Supplementary Material - Springer Static Content Server10.1007/s123… · Web viewBerg K,...
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Supplementary Material
Figure S1: Updated search strategy to identify evidence on AMD and the
specified interventions and comparators in Ovid MEDLINE
1 retinal degeneration/ or exp macular degeneration/ (25843)2 Retinal Neovascularization/ (2346)3 Choroidal Neovascularization/ (4331)4 exp Macula Lutea/ (10610)5 maculopath$.ti,ab,kf. (3309)6 ((macula$ or retina$ or sub-retina$ or choroid$) adj3 (degener$ or neovascula$ or neo-vascula$)).ti,ab,kf. (26136)7 (macula$ adj3 lutea).ti,ab,kf. (400)8 (AMD or wAMD or GAMD or ARMD or wARMD or CNV or mCNV or nAMD).ti,ab,kf. (13780)9 or/1-8 (54123)10 Vascular Endothelial Growth Factor A/ (38654)11 angiogenesis inhibitors/ (18444)12 antibodies, monoclonal, humanized/ (28873)13 bevacizumab/ (7825)14 ranibizumab/ (1920)15 photosensitizing agents/ (11222)16 phototherapy/ or exp photochemotherapy/ (20374)17 (aflibercept or eylea$ or zaltrap$ or trapeye$ or trap-eye$ or 862111-32-8 or "862111328" or 8621-11-328 or 862111-328 or 862-111-328).ti,ab,rn,kf. (714)18 (ranibizumab or lucentis$ or rhufab$ or 347396-82-1 or "347396821" or 347396-821 or 347-396-821 or 3473-96-821).ti,ab,rn,kf. (2694)19 (bevacizumab or avastin$ or 216974-75-3 or "216974753" or 216974-753 or 216-974-753 or 2169-74-753).ti,ab,rn,kf. (11929)20 (photodynamic$ or photo-dynamic$ or phototherap$ or photo-therap$ or photosensiti$ or photo-sensiti$ or photochemotherap$ or photo-chemotherap$ or pdt).ti,ab,kf. (39844)21 porphyrins/ (14851)22 (verteporfin or visudyne$ or benzoporphyrin or porphyrin or 129497-78-5 or "129497785" or 129497-785 or 129-497-785 or 1294-97-785).ti,ab,rn,kf. (15453)
1
1
2
3
4
56789
10111213141516171819202122232425262728293031323334353637
23 (fovista or E10030 or anti-PDGF or antiPDGF or anti-platelet derived growth factor$1 or antiplatelet derived growth factor$1 or pegpleranib).ti,ab,rn,kf. (341)24 or/10-23 (142433)25 9 and 24 (7590)26 exp animals/ not humans/ (4189142)27 25 not 26 (6845)
We also searched the following congress abstracts on 1 March 2016 (full details are
provided in Appendix A): American Association of Ophthalmology (AAO) congress
abstracts (2013-2016); Association for Research in Vision and Ophthalmology
(ARVO) congress abstracts (2013-2016); European Society of Retina Specialists
(EURETINA) congress abstracts (2013-2016); and we assessed the reference lists
of relevant reviews to identify any studies missed by the database searches.
2
38394041424344
45
46
47
48
49
50
51
5253
Table S1. Information sources searched for the review
Database InterfaceDate searched
MEDLINE and MEDLINE In-Process
OvidSP 25/2/16
EMBASE OvidSP 25/2/16
Cochrane Database of Systematic Reviews (CDSR)
Cochrane Library/Wiley Interscience
25/2/16
Cochrane Central Register of Controlled Trials (CENTRAL)
Cochrane Library/Wiley Interscience
25/2/16
DARE Database of Abstracts of Reviews of Effects (DARE)
Cochrane Library/Wiley Interscience
25/2/16
Health Technology Assessment Database (HTA)
Cochrane Library/Wiley Interscience
25/2/16
Science Citation Index (SCI) and Conference Proceedings Citation Index – Science (CPCI-S)
Web of Science 25/2/16
Biosis Biosis Citation Index (Web of Science)
1/3/16
FDA website http://www.fda.gov/ 1/3/16
NICE website http://www.nice.org.uk/ 1/3/16
AHRQ website http://www.ahrq.gov/ 1/3/16
CADTH website http://www.cadth.ca/ 1/3/16
ClinicalTrials.gov www.clinicaltrials.gov 1/3/16
World Health Organization International Clinical Trials Registry Platform (WHO ICTRP)
http://apps.who.int/trialsearch/
1/3/16
ISRCTTN registry (replaces previous Current Controlled Trials, including MRC Trials)
http://www.controlled-trials.com/
1/3/16
3
54
Database InterfaceDate searched
NHS EEDCochrane Library
25/2/16
Econlit Ovid 29/2/16
Cost-effectiveness analysis registry
https://research.tufts-nemc.org/cear4/1
29/2/16
1 The original search included a search of HEED. This database has now ceased publication.
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56
1
Table S2. Number of records identified from each resource
DatabaseNumber of records downloaded
Number of unique records remaining for assessment after deduplication
MEDLINE and MEDLINE In-Process 2,845 2,257
EMBASE 7,250 923
Cochrane Database of Systematic Reviews (CDSR)
32 7
Cochrane Central Register of Controlled Trials (CENTRAL)
850 56
DARE Database of Abstracts of Reviews of Effects (DARE)
53 16
Health Technology Assessment Database (HTA)
67 21
Science Citation Index (SCI) and Conference Proceedings Citation Index – Science (CPCI-S)
6,107 566
Biosis 3,335 161
FDA website 5 5
NICE website 1 1
AHRQ website 0 0
CADTH website 8 5
ClinicalTrials.gov 624 383
World Health Organization International Clinical Trials Registry Platform (WHO ICTRP)
1,293 1,088
ISRCTN registry (replaces previous Current Controlled Trials, including MRC Trials)
35 23
NHS EED 47 5
Econlit 23 11
5
57
58
DatabaseNumber of records downloaded
Number of unique records remaining for assessment after deduplication
Cost-effectiveness analysis registry 125 14
American Association of Ophthalmology (AAO) congress abstracts
28 28
ARVO 205 2
EURETINA 14 14
Number of records found by checking trial records for associated publications
1 1
Total number of records 22,948 5,587
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Table S3. Similarity of methods used in candidate trials considered for inclusion in the NMA of treatments for nAMD: Methods of
randomisation, allocation concealment, blinding, follow up and analysis methods
Study nameMethod of
randomisation and allocation
concealment
Blinding Follow up duration/ months
Number of drop outs – lost to follow up
ITT analysis and methods used to impute
missing dataPatient and personnel
Outcome assessment
ANCHOR (1) Not described. Yes Yes 24
Ranibizumab 0.3mg: 23 (16.4%);
Ranibizumab 0.5mg: 24 (17.1%);
PDT: 33 (23.1%).
ITT analysis was conducted on all
randomised patients. Complete case analysis was used to account for
missing data.
BeMOc (2) Not described. No No 54 weeksLoading dose arm: 0;
PRN arm: 1 (2%).
Analysis was carried out on the per-protocol
population; Complete case analysis was used to
account for missing data.
Biswas 2011 (3)
Randomisation list created using a random
number table;
Method of allocation concealment not
described.
Patients: Unclear;
Personnel: YesUnclear 18
Ranibizumab: 6 (10%);
Bevacizumab: 10 (16.7%).
Analysed as randomised. Complete case analysis was used to account for
missing data.
BRAMD (4) Not described. Unclear Unclear 12 Not reportedAuthors reported an ITT
approach was used, but no information is provided on
7
60
61
62
Study nameMethod of
randomisation and allocation
concealment
Blinding Follow up duration/ months
Number of drop outs – lost to follow up
ITT analysis and methods used to impute
missing dataPatient and personnel
Outcome assessment
how missing data were imputed.
CATT (5)
Patients randomly assigned in block;
Method of allocation concealment was not
described.
No No 24
Ranibizumab monthly: 12 (8.2%)
Bevacizumab monthly: 6 (4.4%);
Ranibizumab PRN: 23 (8%);
Bevacizumab PRN: 19 (7.0%);
Ranibizumab switched: 8 (5.8%);
Bevacizumab switched: 9 (6.9%).
Complete case analysis was used. Other methods were used in sensitivity analysis (analysis not
reported).
DETAIL (6)
Method of randomisation was not
reported; allocation was not concealed as this
was an open label trial.
No No 12 Unclear
It was unclear whether the ITT population was
analysed. It is unclear how missing data were
managed in the analysis.
ENS12 (7)
Randomisation list created using a
computer; allocation was not concealed as this was an open label
trial.
No Yes 12None. All patients
completed the 12-month follow-up
ITT analysis was conducted on all
randomised patients. All patients completed the
study.
ENS5 (8) Method of No No 12 Bevacizumab 4 weeks: It was unclear whether the
8
Study nameMethod of
randomisation and allocation
concealment
Blinding Follow up duration/ months
Number of drop outs – lost to follow up
ITT analysis and methods used to impute
missing dataPatient and personnel
Outcome assessment
randomisation was not reported; allocation was
not concealed as this was an open label trial.
18 (28.1%);
Bevacizumab 6 weeks: 6 (9.5%);
Bevacizumab 8 weeks: 10 (15.6%).
ITT population was analysed. It is unclear how
missing data were managed in the analysis.
EXTEND-I (9)
Method of randomisation was not
reported; allocation was not concealed as this
was an open label trial.
No No 36
At 24 months
Ranibizumab 0.3mg: 11 (30.1%);
Ranibizumab 0.5mg: 9 (25%).
ITT analysis was conducted on all
randomised patients. Complete case analysis
was used for missing data.
FOCUS (10) Not described.Patients: Yes;
Personnel: Some
Yes 24Ranibizumab: 9 (16.1%);
PDT: 15 (14.2%).
ITT analysis was conducted on all
randomised patients. LOCF method was used
for missing data.
GEFAL 2013 (11) Not described. Yes Yes 12
Bevacizumab: 64 (25.1%);
Ranibizumab: 63 (25.6%).
Analysis carried out on per-protocol population. Complete case analysis
was used for missing data.
9
Study nameMethod of
randomisation and allocation
concealment
Blinding Follow up duration/ months
Number of drop outs – lost to follow up
ITT analysis and methods used to impute
missing dataPatient and personnel
Outcome assessment
Giustolisi 2011 (12)
Method of randomisation was not described; allocation was not concealed as this was an open-label
trial.
No Yes 6 None. All patients completed the study.
ITT analysis was conducted on all
randomised patients. All patients completed the
study.
HARBOR (13)
Randomisation list created using a
computer; method of allocation concealment
was not reported clearly.
Yes Yes 24
Ranibizumab 0.5mg monthly: 18 (6.2%);
Ranibizumab 0.5mg PRN: 12 (4.4%);
Ranibizumab 2mg monthly: 16 (5.8%);
Ranibizumab 2mg PRN: 15 (5.5%).
ITT analysis was conducted on all
randomised patients. LOCF method was used
for missing data.
IVAN (14)
Randomisation list created using computer and concealed via an
internet based system.
Yes Yes 24
Ranibizumab monthly: 23 (14.6%);
Bevacizumab monthly: 21 (14.2%);
Ranibizumab PRN: 18 (11.6%);
Bevacizumab PRN: 18 (12.4%).
Modified ITT analysis was conducted, based on the
requirement that a participant must have
received at least one dose of the allocated drug.
Complete case analysis was used for missing data.
Lebanon (15) Not described. No Yes 6Bevacizumab: 0;
PDT: 2 (6.25%).
It was unclear whether the ITT population was
analysed. Complete case analysis was used for
10
Study nameMethod of
randomisation and allocation
concealment
Blinding Follow up duration/ months
Number of drop outs – lost to follow up
ITT analysis and methods used to impute
missing dataPatient and personnel
Outcome assessment
missing data.
LUCAS (16)
Randomisation was computer generated
using fixed blocks and stratified by centre.
Method of allocation concealment was not
described.
Yes Yes 24
Bevacizumab (Year 1): 36 (16.4%*);
Bevacizumab (Year 2): 17 (24.1%);
Ranibizumab (Year 1): 34 (15.4%*);
Ranibizumab (Year 2): 15 (22.2%*).
Authors reported conducting an ITT, but only
213/220 (Bevacizumab) and 218/221
(Ranibizumab) patients were included in the
efficacy analysis.
MAAM (17)
Method of randomisation was not
reported; allocation was concealed via sealed
envelopes.
Patients: Yes; Personnel: No. Yes 6 Unclear
It was unclear whether the ITT population was
analysed. It is unclear how missing data were
managed in the analysis.
MANTA (18) Not described. Yes Yes 12
Bevacizumab: 33 (17.3%);
Ranibizumab: 36 (22.1%).
ITT analysis was conducted on all
randomised patients. LOCF method was used
for missing data.
MARINA (19)
Randomisation list created using "dynamic
algorithm";
method of allocation concealment was not
reported.
Yes Yes 24 Unclear
ITT analysis was conducted on all
randomised patients. LOCF method was used
for missing data.
11
Study nameMethod of
randomisation and allocation
concealment
Blinding Follow up duration/ months
Number of drop outs – lost to follow up
ITT analysis and methods used to impute
missing dataPatient and personnel
Outcome assessment
Moon 2011 (20)
Method of randomisation was not
reported; allocation was not concealed as this
was an open label trial.
No No 12 Unclear
Population analysed was not reported. The method
of dealing with missing data was not reported.
NCT01089517 (21) Not described. Unclear Unclear Not reported
Ranibizumab: 4 (2.7%*);
Pegpleranib (low dose) plus Ranibizumab: 5
(3.4%*);
Pegpleranib (high dose) plus Ranibizumab: 5
(3.3%*).
ITT analysis was conducted and missing
values were imputed using the LOCF method.
Subramanian 2010 (22)
Method of randomisation was not described; allocation
was concealed by pharmacist using identical syringes.
Yes Yes 12 Unclear
Population analysed was not reported. The method
of dealing with missing data was not reported.
TREX-AMD (23)
Unclear - patients were randomised
sequentially, but the randomisation process
was not described.
No No 12 Ranibizumab, monthly: 1 (5%*);
Ranibizumab,
Treat and extend: 6 (15%*).
Authors reported conducting an ITT, but only
19/20 (Ranibizumab, monthly) and 37/40
(Ranibizumab, TREX) patients were included in
ITT analysis.
Authors also report results for the per-protocol
12
Study nameMethod of
randomisation and allocation
concealment
Blinding Follow up duration/ months
Number of drop outs – lost to follow up
ITT analysis and methods used to impute
missing dataPatient and personnel
Outcome assessment
population.
VIEW I (24)
Randomisation list generated centrally using fixed blocks;
method of allocation concealment was not
reported.
Yes Yes. 96 weeks
VIEW 1 and II combined
Ranibizumab: 90 (14.8%);
Aflibercept 2.0mg 4 weeks: 88 (14.3%);
Aflibercept 0.5mg 4 weeks: 113 (18.4%);
Aflibercept 2.0mg 8 weeks: 103 (16.7%).
Modified ITT analysis was conducted, based on the
requirement that participant must have a baseline and one post baseline assessment.
LOCF method was used for missing data, although exceptions were applied.
VIEW II (24)
Randomisation list generated centrally using fixed blocks;
method of allocation concealment was not
reported.
Yes Yes. 96 weeks
VIEW 1 and II combined
Ranibizumab: 90 (14.8%);
Aflibercept 2.0mg 4 weeks: 88 (14.3%);
Aflibercept 0.5mg 4 weeks: 113 (18.4%);
Aflibercept 2.0mg 8 weeks: 103 (16.7%).
Modified ITT analysis was conducted, based on the
requirement that participant must have a baseline and one post baseline assessment.
LOCF method was used for missing data, although exceptions were applied.
ITT- Intention to treat; LOCF – last observation carried forward; * - calculated percentages
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6364
Table S4. Candidate trials and interventions assessed in the feasibility assessment of interventions for nAMD
ANCH
OR
BeM
Oc
Bisw
as
BRAM
D
CATT
DETA
IL
ENS-
12 (E
l-Mol
laye
ss 2
012)
ENS-
5 (L
ushc
hyk
2013
)
EXTE
ND-
1
FOCU
S
GEFA
L
Gius
tolis
i
HARB
OR
IVAN
Leba
non
LUCA
S IT
T
MAA
M
MAN
TA
MAR
INA
Moo
n 20
11
OPH
1001
Subr
aman
ian
TREX
-AM
D IT
T
VIEW
1
VIEW
1.5
VIEW
2
TOTA
L (a
ll st
udie
s)
AflibeceptA0.512xmon,PRN
301 613 296 1210A2.012xmon,PRN
304 597 309 1210A2.06x8-wkly,PRN
301 607 306 1214BevacizumabB1.0singledose+PEG0.36wklyPRN 17 17
B1.25 TREX213 213
B1.2512xmon,PRN 117 117B1.253x6weeks,PRN 50 50B1.253xmon,PRN 50 191 144 154 7 546B1.256wkly 57 13 70B1.258wkly 54 54B1.25fixmon 161 130 60 46 144 541B1.25PRN 49 251 60 360B2.5PRN
32 32PDTPDTPRN 143 56 30 229Pegaptanib
14
65
PEG0.3 6wklyPRN18 18
RanibizumabR 0.5 PRN 269 269R0.312xmon,PRN 35 35R0.33xmon,PRN N/A 0R0.36 xmon,Obs N/A 0R0.3fixmon 140 238 378R0.5 TREX
218 37 255R0.5+pegpleranib_fixmon
152 152R0.512xmon,PRN 127 41 304 595 291 1358R0.51xmon,PRN+vPDT1xmon,PRNfrommon3
17 17
R0.53xmon,PRN 54 N/A 183 30 275 154 163 N/A 15 874R0.56xmon,Obs N/A 0R0.5fixmon 139 166 134 275 155 240 N/A 148 19 1276R0.5fixmon+PDTPRN 105 105R2.03xmon,PRN 273 N/A 273R2.0fixmon 274 N/A 274ShamShamIVT
238 238
15
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Table S5. List of studies included in the NMA*
Study name Reports
ANCHOR
Revicki DA, Rentz AM, Harnam N, Thomas VS, Lanzetta P. Reliability and Validity of the National Eye Institute Visual Function Questionnaire-25 in Patients with Age-Related Macular Degeneration. Investigative Ophthalmology & Visual Science 2010;51(2):712-717. Bressler NM, Chang TS, Suner IJ, Fine JT, Dolan CM, Ward J, et al. Vision-related function after ranibizumab treatment by better- or worse-seeing eye: clinical trial results from MARINA and ANCHOR. Ophthalmology 2010;117(4):747-56 e4. Suner IJ, Kokame GT, Yu E, Ward J, Dolan C, Bressler NM. Responsiveness of NEI VFQ-25 to changes in visual acuity in neovascular AMD: Validation studies from two phase 3 clinical trials. Investigative Ophthalmology and Visual Science 2009;50(8):3629-3635.Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med 2006;355(14):1432-44.Kaiser PK, Brown DM, Zhang K, Hudson HL, Holz FG, Shapiro H, et al. Ranibizumab for predominantly classic neovascular age-related macular degeneration: subgroup analysis of first-year ANCHOR results. Am J Ophthalmol 2007;144(6):850-857. Bressler NM, Chang TS, Fine JT, Dolan CM, Ward J. Improved vision-related function after ranibizumab vs photodynamic therapy: a randomized clinical trial. Arch Ophthalmol 2009;127(1):13-21. Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: Two-year results of the ANCHOR study. Ophthalmology 2009;116(1):57-65 e5. Sadda SR, Stoller G, Boyer DS, Blodi BA, Shapiro H, Ianchulev T. Anatomical benefit from ranibizumab treatment of predominantly classic neovascular age-related macular degeneration in the 2-year ANCHOR study. Retina 2010;30(9):1390-1399.
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67
68
Study name Reports
Biswas (2011)
Biswas P, Sengupta S, Choudhary R, Home S, Paul A, Sinha S. Comparative role of intravitreal ranibizumab versus bevacizumab in choroidal neovascular membrane in age-related macular degeneration. Indian J Ophthalmol 2011;59:191-6
CATT
CATT Research group, et al. Ranibizumab and Bevacizumab for treatment of neovascular age-related macular degeneration. Two year results. Ophthalmology 2012;119(7):1388-99DeCroos, F. C., et al. (2012). Optical coherence tomography grading reproducibility during the Comparison of Age-related Macular Degeneration Treatments Trials. Ophthalmology 119(12): 2549-2557.Catt Research Group. (2011). Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med 364(20): 1897-1908.Grunwald, J. E., et al. (2012). Photographic assessment of baseline fundus morphologic features in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology 119(8): 1634-1641.Martin DF, Maguire MG, Fine SL, Ying GS, Jaffe GJ, Grunwald JE, et al. Ranibizumab and Bevacizumab for Treatment of Neovascular Age-Related Macular Degeneration. Ophthalmology. 2012;119(7).
FOCUS
Heier JS, Boyer DS, Ciulla TA, Ferrone PJ, Jumper JM, Gentile RC, et al. Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration: year 1 results of the FOCUS Study. Arch Ophthalmol 2006;124(11):1532-42. Antoszyk AN, Tuomi L, Chung CY, Singh A. Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration (FOCUS): year 2 results. Am J Ophthalmol 2008;145(5):862-74. Apte RS, Alexander SL, Henry EC, Wong P, Tuomi L. An observational retrospective subgroup analysis of verteporfin photodynamic therapy-naive and previously treated patients in the focus trial. Retina 2011;31(1):56-64.
GEFAL (2013)Kodjikian L, Souied EH, Mimoun G, Mauget-Faysse M, Behar-Cohen F, Decullier E, et al. Ranibizumab versus Bevacizumab for Neovascular Age-related Macular Degeneration: Results from the GEFAL Noninferiority Randomized Trial. Ophthalmology. 2013;120(11):2300-9.
Giustolisi 2011
Giustolisi R, Fantozzi N, Staltari M, Marchiori J, Mastrangelo O, Marcucci R, et al. Combined intravitreal ranibizumab and verteporfin photodynamic therapy versus ranibizumab alone for the treatment of age-related macular
17
Study name Reportsdegeneration. Digital Journal of Ophthalmology 2011;17(3):23-30.
IVAN
Chakravarthy U, et al. Ranibizumab versus Bevacizumab to Treat Neovascular Age-related Macular Degeneration: One-Year Findings from the IVAN Randomized Trial. Ophthalmology 2012 Jul;119(7):1399-411.Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Culliford LA, et al. Alternative treatments to inhibit VEGF in age-related choroidal neovascularisation: 2-year findings of the IVAN randomised controlled trial. Lancet. 2013;382(9900):1258-67.
MANTA
Krebs I, Vecsei Marlovits V, Bodenstorfer J, Glittenberg C, Ansari Shahrezaei S, Ristl R, et al. Comparison of Ranibizumab monotherapy versus combination of Ranibizumab with photodynamic therapy with neovascular age-related macular degeneration. Acta Ophthalmol (Oxf). 2013;91(3):e178-83.Krebs I , Schmetterer L, Boltz A, Told R, Vecsei-Marlovits V, Egger S, et al. A randomised double-masked trial comparing the visual outcome after treatment with ranibizumab or bevacizumab in patients with neovascular age-related macular degeneration. Br J Ophthalmol. 2013;97(3):266-71.
MARINA
Yue H, Kotlovker D, Shams N. A phase IIIb, multicenter, randomized, double-masked, sham injection−controlled study of the efficacy and safety of ranibizumab in subjects with subfoveal choroidal neovascularization (CNV) with or without classic CNV secondary to age-related macular degeneration. San Francisco: Genentech, Inc.; 2007. Chang TS, Bressler NM, Fine JT, Dolan CM, Ward J, Klesert TR. Improved vision-related function after ranibizumab treatment of neovascular age-related macular degeneration: results of a randomized clinical trial. Arch Ophthalmol 2007;125(11):1460-9.
Kaiser PK, Blodi BA, Shapiro H, Acharya NR, Group MS. Angiographic and optical coherence tomographic results of the MARINA study of ranibizumab in neovascular age-related macular degeneration. Ophthalmology 2007;114(10):1868-75.
Boyer DS, Antoszyk AN, Awh CC, Bhisitkul RB, Shapiro H, Acharya NR. Subgroup analysis of the MARINA study of ranibizumab in neovascular age-related macular degeneration. Ophthalmology 2007;114(2):246-52.
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Study name ReportsBressler NM, Chang TS, Suner IJ, Fine JT, Dolan CM, Ward J, et al. Vision-related function after ranibizumab treatment by better- or worse-seeing eye: clinical trial results from MARINA and ANCHOR. Ophthalmology 2010;117(4):747-56 e4. Suner IJ, Kokame GT, Yu E, Ward J, Dolan C, Bressler NM. Responsiveness of NEI VFQ-25 to changes in visual acuity in neovascular AMD: Validation studies from two phase 3 clinical trials. Investigative Ophthalmology and Visual Science 2009;50(8):3629-3635.
Revicki DA, Rentz AM, Harnam N, Thomas VS, Lanzetta P. Reliability and Validity of the National Eye Institute Visual Function Questionnaire-25 in Patients with Age-Related Macular Degeneration. Investigative Ophthalmology & Visual Science 2010;51(2):712-717.
Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355(14):1419-31.
OPH1001Ophthotech Corporation. A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration. US: In: Clinicaltrials.gov [Internet], 2013.
Subramanian (2010)
Subramanian ML, Abedi G, Ness S, Ahmed E, Fenberg M, Daly MK, et al. Bevacizumab vs ranibizumab for age-related macular degeneration: 1-year outcomes of a prospective, double-masked randomised clinical trial. Eye. 2010;24(11):1708-15.
VIEW 1
Heier JS, VIEW 1 and VIEW 2 investigators. 96 weeks results from the VIEW 1 and VIEW 2 studies: Intravitreal aflibercept injection versus ranibizumab for neovascular AMD shows sustained improvements in visual acuity. ARVO 2012. Available at: http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=14c6c603-88a2-46c6-8de1-ac24d9f71e9f&cKey=d2fd93bb-6f0e-4a1b-bdc0-b76e87b5b90a&mKey=%7bF0FCE029-9BF8-4E7C-B48E-9FF7711D4A0E%7d. Schmidt-Erfurth U, Heier JS, Majid A, Vitti R. Results of the phase 3 VIEW 1 and VIEW 2 studies of VEGF Trap-Eye vs. ranibizumab in nAMD. XXXIII International Congress of Ophthalmology 16-20th February 2012, Abu Dhabi, United Arab Emirates. Available at: http://www.woc2012.org/files/abstract_book_woc2012.pdf
19
Study name ReportsBayer Healthcare. Summary Report for the studies VIEW 1 and VIEW 2. Two randomized, double masked, active controlled, phase 3 studies of the efficacy, safety, and tolerability of repeated doses of intravitreal VEGF Trap-Eye in subjects with neovascular age-related macular degeneration (AMD). Bayer Healthcare; 2012. Regeneron Pharmaceuticals Inc. Clinical Summary Report: VIEW 1 study at 96 weeks. Regeneron Pharmaceuticals; 2012.Schmidt-Erfurth U, Heier JS, Majid A, Vitti R. Results of the phase 3 VIEW 1 and VIEW 2 studies of VEGF Trap-Eye vs. ranibizumab in nAMD. XXXIII International Congress of Ophthalmology 16-20th February 2012, Abu Dhabi, United Arab Emirates. Available at: http://www.woc2012.org/files/abstract_book_woc2012.pdf
HARBOR Busbee BG, Ho AC, Brown DM, Heier JS, Suner IJ, Li Z, et al. Twelve-month efficacy and safety of 0.5 mg or 2.0 mg ranibizumab in patients with subfoveal neovascular age-related macular degeneration. Ophthalmology. 2013;120(5):1046-56.
VIEW 2
Heier JS, VIEW 1 and VIEW 2 investigators. 96 weeks results from the VIEW 1 and VIEW 2 studies: Intravitreal aflibercept injection versus ranibizumab for neovascular AMD shows sustained improvements in visual acuity. ARVO 2012. Available at: http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=14c6c603-88a2-46c6-8de1-ac24d9f71e9f&cKey=d2fd93bb-6f0e-4a1b-bdc0-b76e87b5b90a&mKey=%7bF0FCE029-9BF8-4E7C-B48E-9FF7711D4A0E%7d. Schmidt-Erfurth U, Heier JS, Majid A, Vitti R. Results of the phase 3 VIEW 1 and VIEW 2 studies of VEGF Trap-Eye vs. ranibizumab in nAMD. XXXIII International Congress of Ophthalmology, 16-20th February 2012, Abu Dhabi, United Arab Emirates. Available at: http://www.woc2012.org/files/abstract_book_woc2012.pdf.
Bayer Healthcare. Summary Report for the studies VIEW 1 and VIEW 2. Two randomized, double masked, active controlled, phase 3 studies of the efficacy, safety, and tolerability of repeated doses of intravitreal VEGF Trap-Eye in subjects with neovascular age-related macular degeneration (AMD). Bayer Healthcare: 2012.
Bayer Healthcare. Clinical Study Report (2 years). VIEW 2. Report No.: A62515. Bayer Healthcare; 2012.
20
Study name ReportsRegeneron Pharmaceuticals Inc. Clinical Summary Report: VIEW 1 study at 52 weeks. Regeneron Pharmaceuticals: 2011.Bayer Healthcare. Integrated Study Protocol (VIEW 2): A randomized, double masked, active controlled, phase 3 study of the efficacy, safety, and tolerability of repeated doses of intravitreal VEGF Trap-Eye in subjects with neovascular age-related macular degeneration (AMD). Report No.: 311523. Bayer Healthcare; 2008.
Bayer Healthcare. Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) (VIEW 2). Bayer Healthcare; 2012.. Available from: http://clinicaltrials.gov/ct2/show/NCT00637377?term=VIEW&rank=7
Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, et al. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012;119(12):2537-48.
EXTEND-1
Tano Y, et al. EXTEND-I: safety and efficacy of ranibizumab in Japanese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. Acta Ophthalmol 2010;88(3):309-16.
Tano Y, Ohji M, Group E-IS. Long-term efficacy and safety of ranibizumab administered pro re nata in Japanese patients with neovascular age-related macular degeneration in the EXTEND-I study. Acta Ophthalmol. 2011;89(3):208-17.
Lebanon
Bashshur ZF, Schakal A, Hamam RN, El Haibi CP, Jaafar RF, Noureddin BN. Intravitreal bevacizumab vs verteporfin photodynamic therapy for neovascular age-related macular degeneration. Arch Ophthalmol 2007;125(10):1357-61.
Moon E, et al. 133/A268 Monthly versus PRN Ranibizumab for Neovascular AMD: A Randomized Phase 2 Open-Label Study. In: Fort Lauderdale: Association for Research in Vision and Ophthalmology; 2011: . NCT00764738. Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration. Torrance, CA: Retina Macula Institute; 2013.
ENS-12El-Mollayess GM, Mahfoud Z, Schakal AR, Salti HI, Jaafar D, Bashshur ZF. Fixed-Interval Versus OCT-Guided Variable Dosing of Intravitreal Bevacizumab in the Management of Neovascular Age-Related Macular Degeneration: A 12-
21
Study name ReportsMonth Randomized Prospective Study. Am J Ophthalmol. 2012;153(3):481-9.e1.
ENS-5Lushchyk, T., S. Amarakoon, et al. (2013). Bevacizumab in age-related macular degeneration: a randomized controlled trial on the effect of injections every 4weeks, 6weeks and 8weeks. Acta Opthalmologica 91(6): e456-461.
MAAM
Schmid-Kubista KE, Krebs I, Ansari-Shahrezaei S, Haas P, Hagen S, Binder S. Comparing treatment of neovascular age-related macular degeneration with sequential intravitreal Avastin and Macugen versus intravitreal mono-therapy--a pilot study. Curr Eye Res. 2011;36(10):958-63.Schmid-Kubista KE, Krebs I, Gruenberger B, Zeiler F, Schueller J, Binder S. Systemic bevacizumab (Avastin) therapy for exudative neovascular age-related macular degeneration. The BEAT-AMD-Study. Br J Ophthalmol. 2009;93(7):914-9.
BeMOcMenon G, Chandran M, Sivaprasad S, Chavan R, Narendran N, Yang Y. Is it necessary to use three mandatory loading doses when commencing therapy for neovascular age-related macular degeneration using bevacizumab? (BeMOc Trial). Eye (Lond). 2013;27(8):959-63..
LUCAS
Berg K, Hadzalic E, Gjertsen I, Forsaa V, Berger LH, Kinge B, et al. Ranibizumab or Bevacizumab for Neovascular Age-Related Macular Degeneration According to the Lucentis Compared to Avastin Study Treat-and-Extend Protocol: Two-Year Results. Ophthalmology. 2016;123(1):51-9.Berg K, Pedersen TR, Sandvik L, Bragadottir R. Comparison of ranibizumab and bevacizumab for neovascular age-related macular degeneration according to LUCAS treat-and-extend protocol. Ophthalmology. 2015;122(1):146-52.
TREXWykoff CC, Croft DE, Brown DM, Wang R, Payne JF, Clark L, et al. Prospective Trial of Treat-and-Extend versus Monthly Dosing for Neovascular Age-Related Macular Degeneration: TREX-AMD 1-Year Results. Ophthalmology. 2015;122(12):2514-22.
*Two studies DETAIL and MOON did not report sufficient data for inclusion in the NMA
22
69
Table S6: A key to the trials and their corresponding IDs included in the network
diagram of mean change in VA of treatments for nAMD
Trial ID used in the network diagrams
ANCHOR A
BeMOc B
Biswas 2011 C
BRAMD D
CATT E
DETAIL F
ENS12 G
ENS5 H
EXTEND-I I
FOCUS J
GEFAL 2013 K
Giustolisi 2011 L
HARBOR M
IVAN N
Lebanon O
LUCAS P
MAAM Q
MANTA R
MARINA S
Moon 2011 T
NCT01089517 U
Subramanian 2010 V
TREX-AMD W
VIEW I X
VIEW II Y
23
70
71
24
72
Figure S2: A) Potential network available for mean change in visual acuity in treatments for nAMD at 0-3 months
25
73
B) Potential network available for mean change in visual acuity in treatments for nAMD at 4-12 months
26
74
75
C) Potential network available for mean change in visual acuity in treatments for nAMD at 13-24 months
27
76
77
Table S7: Assumptions regarding the equivalence of dosing regimens at 0–3 and 4–12 months for the networks of mean change in VA of
treatments for nAMD
Time frame Dosing regimen Assumed equivalent dosage
0 – 12 months
R 0.3 mg 12 x monthly, PRNRanibizumab 0.3mg fixed monthly
R 0.3 mg fixed monthlyR 0.5 12 x monthly, PRN
Ranibizumab 0.5mg fixed monthlyR 0.5 fixed monthly B 1.25 mg 12X monthly, PRN
Bevacizumab 1.25 monthlyB 1.25 fixed monthly
12 -24 months
R 0.3mg 12 x monthly, PRNRanibizumab 0.3mg fixed monthly
R 0.3 mg fixed monthlyR 0.5mg 12 x monthly, PRN
Ranibizumab 0.5mg fixed monthlyR 0.5 fixed monthlyB 1.25 mg 12X monthly, PRN
Bevacizumab 1.25 monthlyB 1.25 fixed monthly
PRN, pro re nata; T&E, treat and extend; R, ranibizumab; B, bevacizumab
28
78
79
8081
APPENDIX 1A: Full Search Strategies
This appendix includes the searches conducted for the Ranibizumab nAMD review in
August 2013 and also the searches conducted for this updated and expanded review
in February 2016.
29
82
83
84
85
86
A.1 MEDLINE
A.1.1. MEDLINE In-Process & Other Non-Indexed Citations and Ovid MEDLINE (Ovid SP, 1946 to Present). Searched 27/08/13.
1 retinal degeneration/ or exp macular degeneration/ (24136)
2 Retinal Neovascularization/ (2317)
3 Choroidal Neovascularization/ (4602)
4 exp Macula Lutea/ (10124)
5 maculopath$.ti,ab. (2960)
6 ((macula$ or retina$ or sub-retina$ or choroid$) adj3 (degener$ or neovascula$
or neo-vascula$)).ti,ab. (24201)
7 (macula$ adj3 lutea).ti,ab. (111)
8 (AMD or wAMD or GAMD or ARMD or wARMD or CNV or mCNV).ti,ab. (12194)
9 or/1-8 (49431)
10 Vascular Endothelial Growth Factor A/ai (6008)
11 Angiogenesis Inhibitors/ (19387)
12 Antibodies, Monoclonal, Humanized/ (31919)
13 Photosensitizing Agents/ (9783)
14 phototherapy/ or exp photochemotherapy/ (18575)
15 (aflibercept or eylea$ or zaltrap$ or trapeye$ or trap-eye$ or 862111-32-8 or
"862111328" or 8621-11-328 or 862111-328 or 862-111-328).ti,ab,rn. (343)
16 (ranibizumab or lucentis$ or rhufab$ or 347396-82-1 or "347396821" or
347396-821 or 347-396-821 or 3473-96-821).ti,ab,rn. (2067)
17 (bevacizumab or avastin$ or altuzan$ or 216974-75-3 or "216974753" or
216974-753 or 216-974-753 or 2169-74-753).ti,ab,rn. (13712)
18 (photodynamic$ or photo-dynamic$ or phototherap$ or photo-therap$ or
photosensiti$ or photo-sensiti$ or photochemotherap$ or photo-chemotherap$ or
pdt).ti,ab. (34872)
19 (verteporfin or visudyne$ or benzoporphyrin or porphyrin or 129497-78-5 or
"129497785" or 129497-785 or 129-497-785 or 1294-97-785).ti,ab,rn. (13646)
20 or/10-19 (98881)
30
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
21 9 and 20 (6520)
22 animals/ not humans/ (3927983)
23 21 not 22 (6117)
A.1.2 MEDLINE In-Process & Other Non-Indexed Citations and Ovid MEDLINE (Ovid SP, 1946 to Present). Searched 25/2/16
1 retinal degeneration/ or exp macular degeneration/ (25843)
2 Retinal Neovascularization/ (2346)
3 Choroidal Neovascularization/ (4331)
4 exp Macula Lutea/ (10610)
5 maculopath$.ti,ab,kf. (3309)
6 ((macula$ or retina$ or sub-retina$ or choroid$) adj3 (degener$ or neovascula$
or neo-vascula$)).ti,ab,kf. (26136)
7 (macula$ adj3 lutea).ti,ab,kf. (400)
8 (AMD or wAMD or GAMD or ARMD or wARMD or CNV or mCNV or
nAMD).ti,ab,kf. (13780)
9 or/1-8 (54123)
10 Vascular Endothelial Growth Factor A/ (38654)
11 angiogenesis inhibitors/ (18444)
12 antibodies, monoclonal, humanized/ (28873)
13 bevacizumab/ (7825)
14 ranibizumab/ (1920)
15 photosensitizing agents/ (11222)
16 phototherapy/ or exp photochemotherapy/ (20374)
17 (aflibercept or eylea$ or zaltrap$ or trapeye$ or trap-eye$ or 862111-32-8 or
"862111328" or 8621-11-328 or 862111-328 or 862-111-328).ti,ab,rn,kf. (714)
18 (ranibizumab or lucentis$ or rhufab$ or 347396-82-1 or "347396821" or
347396-821 or 347-396-821 or 3473-96-821).ti,ab,rn,kf. (2694)
19 (bevacizumab or avastin$ or 216974-75-3 or "216974753" or 216974-753 or
216-974-753 or 2169-74-753).ti,ab,rn,kf. (11929)
31
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
20 (photodynamic$ or photo-dynamic$ or phototherap$ or photo-therap$ or
photosensiti$ or photo-sensiti$ or photochemotherap$ or photo-chemotherap$ or
pdt).ti,ab,kf. (39844)
21 porphyrins/ (14851)
22 (verteporfin or visudyne$ or benzoporphyrin or porphyrin or 129497-78-5 or
"129497785" or 129497-785 or 129-497-785 or 1294-97-785).ti,ab,rn,kf. (15453)
23 (fovista or E10030 or anti-PDGF or antiPDGF or anti-platelet derived growth
factor$1 or antiplatelet derived growth factor$1 or pegpleranib).ti,ab,rn,kf. (341)
24 or/10-23 (142433)
25 9 and 24 (7590)
26 exp animals/ not humans/ (4189142)
27 25 not 26 (6845)
A.2 EMBASE
A.2.1 Embase (OvidSP, 1974 to 2013 August 26). Searched 27/08/13
1 retina degeneration/ (8050)
2 exp retina macula degeneration/ (19251)
3 retina neovascularization/ (3595)
4 subretinal neovascularization/ (6459)
5 retina macula lutea/ (7341)
6 maculopath$.ti,ab. (3495)
7 ((macula$ or retina$ or sub-retina$ or choroid$) adj3 (degener$ or neovascula$
or neo-vascula$)).ti,ab. (26209)
8 (macula$ adj3 lutea).ti,ab. (130)
9 (AMD or wAMD or GAMD or ARMD or wARMD or CNV or mCNV).ti,ab. (13979)
10 or/1-9 (52480)
11 angiogenesis inhibitor/ (13351)
12 monoclonal antibody/ (172618)
13 photosensitizing agent/ (8602)
14 phototherapy/ or photochemotherapy/ or photodynamic therapy/ (35430)
15 aflibercept/ (1181)
32
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
16 ranibizumab/ (3306)
17 bevacizumab/ (28015)
18 verteporfin/ (1087)
19 (ranibizumab or lucentis$ or rhufab$ or 347396-82-1 or "347396821" or
347396-821 or 347-396-821 or 3473-96-821).ti,ab,rn. (3382)
20 (bevacizumab or avastin$ or altuzan$ or 216974-75-3 or "216974753" or
216974-753 or 216-974-753 or 2169-74-753).ti,ab,rn. (28743)
21 (photodynamic$ or photo-dynamic$ or phototherap$ or photo-therap$ or
photosensiti$ or photo-sensiti$ or photochemotherap$ or photo-chemotherap$ or
pdt).ti,ab. (42219)
22 (verteporfin or visudyne$ or benzoporphyrin or porphyrin or 129497-78-5 or
"129497785" or 129497-785 or 129-497-785 or 1294-97-785).ti,ab,rn. (22130)
23 (aflibercept or eylea$ or zaltrap$ or trapeye$ or trap-eye$ or 862111-32-8 or
"862111328" or 8621-11-328 or 862111-328 or 862-111-328).ti,ab,rn. (1199)
24 or/11-23 (281116)
25 10 and 24 (6626)
26 (animal/ or animal experiment/ or animal model/ or nonhuman/) not exp human/
(5026682)
27 25 not 26 (6194)
A.2.2 Embase <1974 to 2016 February 24>. Searched 25/2/16
1 retina degeneration/ or exp macular degeneration/ (12225)
2 Retina Neovascularization/ (3921)
3 subretinal Neovascularization/ (7175)
4 retina Macula Lutea/ (7881)
5 maculopath$.ti,ab,kf. (3896)
6 ((macula$ or retina$ or sub-retina$ or choroid$) adj3 (degener$ or neovascula$
or neo-vascula$)).ti,ab,kf. (30262)
7 (macula$ adj3 lutea).ti,ab,kf. (143)
8 (AMD or wAMD or GAMD or ARMD or wARMD or CNV or mCNV or
nAMD).ti,ab,kf. (17667)
9 or/1-8 (55372)
10 Endothelial Cell Growth Factor/ (2079)
33
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
11 angiogenesis inhibitor/ (14865)
12 monoclonal antibody/ (183822)
13 bevacizumab/ or aflibercept/ or verteporfin/ or pegpleranib/ (40494)
14 ranibizumab/ (5159)
15 photosensitizing agent/ (10247)
16 phototherapy/ or photochemotherapy/ or photodynamic therapy/ (41356)
17 (aflibercept or eylea$ or zaltrap$ or trapeye$ or trap-eye$ or 862111-32-8 or
"862111328" or 8621-11-328 or 862111-328 or 862-111-328).ti,ab,rn,kf. (2485)
18 (ranibizumab or lucentis$ or rhufab$ or 347396-82-1 or "347396821" or
347396-821 or 347-396-821 or 3473-96-821).ti,ab,rn,kf. (5280)
19 (bevacizumab or avastin$ or 216974-75-3 or "216974753" or 216974-753 or
216-974-753 or 2169-74-753).ti,ab,rn,kf. (39767)
20 (photodynamic$ or photo-dynamic$ or phototherap$ or photo-therap$ or
photosensiti$ or photo-sensiti$ or photochemotherap$ or photo-chemotherap$ or
pdt).ti,ab,kf. (48277)
21 porphyrin/ (14043)
22 (verteporfin or visudyne$ or benzoporphyrin or porphyrin or 129497-78-5 or
"129497785" or 129497-785 or 129-497-785 or 1294-97-785).ti,ab,rn,kf. (23772)
23 (fovista or E10030 or anti-PDGF or antiPDGF or anti-platelet derived growth
factor$1 or antiplatelet derived growth factor$1 or pegpleranib).ti,ab,rn,kf. (378)
24 or/10-23 (316845)
25 9 and 24 (7250)
A.3 COCHRANE LIBRARY
Cochrane Database of Systematic Reviews: Issue 8 of 12, August 2013
Database of Abstracts of Reviews of Effects: Issue 3 of 4, July 2013
Cochrane Central Register of Controlled Trials: Issue 7 of 12, July 2013
Health Technology Assessment Database: Issue 3 of 4, July 2013
NHS Economic Evaluation Database: Issue 3 of 4, July 2013
#1 MeSH descriptor: [Retinal Degeneration] this term only 13
#2 MeSH descriptor: [Macular Degeneration] explode all trees 1033
34
220
221
222
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
240
241
242
243
244
245
246
247
248
249
250
251
252
253
#3 MeSH descriptor: [Retinal Neovascularization] this term only 40
#4 MeSH descriptor: [Choroidal Neovascularization] this term only 257
#5 MeSH descriptor: [Macula Lutea] explode all trees 270
#6 maculopath* 222
#7 ((macula* or retina* or "sub-retina*" or choroid*) adj3 (degener* or
neovascula* or "neo-vascula*")) 83
#8 (macula* adj3 lutea) 18
#9 AMD or wAMD or GAMD or ARMD or wARMD or CNV or mCNV 1185
#10 (25-#9) 2163
#11 MeSH descriptor: [Vascular Endothelial Growth Factor A] this term only and
with qualifiers: [Antagonists & inhibitors - AI] 179
#12 MeSH descriptor: [Angiogenesis Inhibitors] this term only 477
#13 MeSH descriptor: [Antibodies, Monoclonal, Humanized] this term only
1542
#14 MeSH descriptor: [Photosensitizing Agents] this term only 365
#15 MeSH descriptor: [Phototherapy] this term only 575
#16 MeSH descriptor: [Photochemotherapy] explode all trees 533
#17 aflibercept or eylea* or zaltrap* or trapeye* or "trap-eye*" or "862111-32-8" or
"862111328" or "8621-11-328" or "862111-328" or "862-111-328" 29
#18 ranibizumab or lucentis* or rhufab* or "347396-82-1" or "347396821" or
"347396-821" or "347-396-821" or "3473-96-821" 234
#19 bevacizumab or avastin* or altuzan* or "216974-75-3" or "216974753" or
"216974-753" or "216-974-753" or "2169-74-753" 781
#20 photodynamic* or "photo-dynamic*" or phototherap* or "photo-therap*" or
"photosensiti*" or "photo-sensiti*" or photochemotherap* or "photo-chemotherap*" or
pdt 2889
#21 verteporfin or visudyne* or benzoporphyrin or porphyrin or "129497-78-5" or
"129497785" or "129497-785" or "129-497-785" or "1294-97-785" 342
#22 (13-#21) 5047
#23 #10 and #22 608
#24 #23 in Cochrane Reviews (Reviews and Protocols) 30
#25 #23 in Other Reviews 22
#26 #23 in Trials 473
#27 #23 in Technology Assessments 45
35
254
255
256
257
258
259
260
261
262
263
264
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
284
285
286
287
#28 #23 in Economic Evaluations 37
Cochrane Library (Wiley InterScience) Searched 25/2/16
Cochrane Database of Systematic Reviews : Issue 2 of 12, February 2016
Database of Abstracts of Reviews of Effect : Issue 2 of 4, April 2015
Cochrane Central Register of Controlled Trials : Issue 1 of 12, January 2016
Health Technology Assessment Database : Issue 1 of 4, January 2016
NHS Economic Evaluation Database: : Issue 2 of 4, April 2015
#1 MeSH descriptor: [Retinal Degeneration] this term only 18
#2 MeSH descriptor: [Macular Degeneration] explode all trees 1441
#3 MeSH descriptor: [Retinal Neovascularization] this term only 55
#4 MeSH descriptor: [Choroidal Neovascularization] this term only 298
#5 MeSH descriptor: [Macula Lutea] explode all trees 325
#6 maculopath* 297
#7 ((macula* or retina* or "sub-retina*" or choroid*) near (degener* or
neovascula* or "neo-vascula*")) 2092
#8 (macula* near lutea) 305
#9 (AMD or wAMD or GAMD or ARMD or wARMD or CNV or mCNV or nAMD)
1513
#10 (26-#9) 3349
#11 MeSH descriptor: [Vascular Endothelial Growth Factor A] this term only
852
#12 MeSH descriptor: [Angiogenesis Inhibitors] this term only 856
#13 MeSH descriptor: [Antibodies, Monoclonal, Humanized] this term only
2894
#14 MeSH descriptor: [Bevacizumab] this term only 563
#15 MeSH descriptor: [Ranibizumab] this term only 252
#16 MeSH descriptor: [Photosensitizing Agents] this term only 538
#17 MeSH descriptor: [Phototherapy] this term only 704
#18 MeSH descriptor: [Photochemotherapy] explode all trees 728
#19 aflibercept or eylea* or zaltrap* or trapeye* or "trap-eye*" or "862111-32-8" or
"862111328" or "8621-11-328" or "862111-328" or "862-111-328" 146
36
288
289
290
291
292
293
294
295
296
297
298
299
300
301
302
303
304
305
306
307
308
309
310
311
312
313
314
315
316
317
318
319
320
321
#20 ranibizumab or lucentis* or rhufab* or "347396-82-1" or "347396821" or
"347396-821" or "347-396-821" or "3473-96-821" 594
#21 bevacizumab or avastin* or altuzan* or "216974-75-3" or "216974753" or
"216974-753" or "216-974-753" or "2169-74-753" 2005
#22 photodynamic* or "photo-dynamic*" or phototherap* or "photo-therap*" or
"photosensiti*" or "photo-sensiti*" or photochemotherap* or "photo-chemotherap*" or
pdt 3981
#23 verteporfin or visudyne* or benzoporphyrin or porphyrin or "129497-78-5" or
"129497785" or "129497-785" or "129-497-785" or "1294-97-785" 363
#24 MeSH descriptor: [Porphyrins] this term only 149
#25 fovista or E10030 or anti-PDGF or antiPDGF or "anti-platelet derived growth
factor*" or "antiplatelet derived growth factor*" or pegpleranib 6
#26 (27-#25) 9044
Cochrane Database of Systematic Reviews: 32 records
Database of Abstracts of Reviews of Effect: 53 records
Cochrane Central Register of Controlled Trials: 850 records
Health Technology Assessment Database: 67 records
NHS Economic Evaluation Database: 47 records
A.4 SCIENCE CITATION INDEX EXPANDED
A.4.1 Science Citation Index Expanded (Web of Science, Thompson Reuters; 1900- 2013-08-23). Searched 27/08/13
Databases=SCI-EXPANDED IC Timespan=All years
# 12 4,501 #11 AND #5
# 11 99,234 #10 OR #9 OR #8 OR #7 OR #6
# 10 33,729 TS=("verteporfin" or "visudyne*" or "benzoporphyrin" or
"porphyrin" or "129497-78-5" or "129497785" or "129497-785" or "129-497-785" or
"1294-97-785")
37
322
323
324
325
326
327
328
329
330
331
332
333
334
335
336
337
338
339
340
341
342
343
344
345
346
347
348
349
350
351
352
353
354
# 9 59,399 TS=("photodynamic*" or "photo-dynamic*" or "phototherap*" or
"photo-therap*" or "photosensiti*" or "photo-sensiti*" or "photochemotherap*" or
"photo-chemotherap*" or "pdt")
# 8 11,565 TS=("bevacizumab" or "avastin*" or "altuzan*" or "216974-75-3"
or "216974753" or "216974-753" or "216-974-753" or "2169-74-753")
# 7 1,921 TS=("ranibizumab" or "lucentis*" or "rhufab*" or "347396-82-1" or
"347396821" or "347396-821" or "347-396-821" or "3473-96-821")
# 6 229 TS=("aflibercept" or "eylea*" or "zaltrap*" or "trapeye*" or "trap-eye*" or
"862111-32-8" or "862111328" or "8621-11-328" or "862111-328" or "862-111-328")
# 5 35,088 #4 OR #3 OR #2 OR #1
# 4 11,868 TS=("AMD" or "wAMD" or "GAMD" or "ARMD" or "wARMD" or
"CNV" or "mCNV")
# 3 76 TS=("macula*" NEAR/3 "lutea")
# 2 26,909 TS=(("macula*" or "retina*" or "sub-retina*" or "choroid*")
NEAR/3 ("degener*" or "neovascula*" or "neo-vascula*"))
# 1 4,722 TS="maculopath*"
A.4.2 Conference Proceedings Citation Index- Science (Web of Science, Thompson Reuters; 1990- 2013-08-23). Searched 28/08/13
Databases=CPCI-S Timespan=All years
# 12 519 #11 AND #5
# 11 14,434 #10 OR #9 OR #8 OR #7 OR #6
# 10 2,886 TS=("verteporfin" or "visudyne*" or "benzoporphyrin" or "porphyrin" or
"129497-78-5" or "129497785" or "129497-785" or "129-497-785" or "1294-97-785")
# 9 10,205 TS=("photodynamic*" or "photo-dynamic*" or "phototherap*" or
"photo-therap*" or "photosensiti*" or "photo-sensiti*" or "photochemotherap*" or
"photo-chemotherap*" or "pdt")
# 8 1,935 TS=("bevacizumab" or "avastin*" or "altuzan*" or "216974-75-3" or
"216974753" or "216974-753" or "216-974-753" or "2169-74-753")
# 7 84 TS=("ranibizumab" or "lucentis*" or "rhufab*" or "347396-82-1" or
"347396821" or "347396-821" or "347-396-821" or "3473-96-821")
# 6 28 TS=("aflibercept" or "eylea*" or "zaltrap*" or "trapeye*" or "trap-eye*" or
"862111-32-8" or "862111328" or "8621-11-328" or "862111-328" or "862-111-328")
38
355
356
357
358
359
360
361
362
363
364
365
366
367
368
369
370
371
372
373
374
375
376
377
378
379
380
381
382
383
384
385
386
387
388
# 5 5,130 #4 OR #3 OR #2 OR #1
# 4 2,286 TS=("AMD" or "wAMD" or "GAMD" or "ARMD" or "wARMD" or "CNV"
or "mCNV")
# 3 10 TS=("macula*" NEAR/3 "lutea")
# 2 3,289 TS=(("macula*" or "retina*" or "sub-retina*" or "choroid*") NEAR/3
("degener*" or "neovascula*" or "neo-vascula*"))
# 1 545 TS="maculopath*"
A.4.3 Science Citation Index Expanded (Web of Science, Thompson Reuters; 1900- 2016-02-24). Searched 25/2/16
Conference Proceedings Citation Index- Science (Web of Science, Thompson
Reuters; 1990- 2016-02-24). Searched 25/2/16
Databases=CPCI-S Timespan=All years
Databases=SCI-EXPANDED IC Timespan=All years
# 13 6,107 #12 AND #5
# 12 129,285 #11 OR #10 OR #9 OR #8 OR #7 OR #6
# 11 288 TS=(“fovista” or “E10030” or “anti-PDGF” or “antiPDGF” or "anti-
platelet derived growth factor*" or "antiplatelet derived growth factor*" or
“pegpleranib”)
# 10 40,076 TS=("verteporfin" or "visudyne*" or "benzoporphyrin" or
"porphyrin" or "129497-78-5" or "129497785" or "129497-785" or "129-497-785" or
"1294-97-785")
# 9 77,120 TS=("photodynamic*" or "photo-dynamic*" or "phototherap*" or
"photo-therap*" or "photosensiti*" or "photo-sensiti*" or "photochemotherap*" or
"photo-chemotherap*" or "pdt")
# 8 17,979 TS=("bevacizumab" or "avastin*" or "altuzan*" or "216974-75-3"
or "216974753" or "216974-753" or "216-974-753" or "2169-74-753")
# 7 3,576 TS=("ranibizumab" or "lucentis*" or "rhufab*" or "347396-82-1" or
"347396821" or "347396-821" or "347-396-821" or "3473-96-821")
39
389
390
391
392
393
394
395
396
397
398
399
400
401
402
403
404
405
406
407
408
409
410
411
412
413
414
415
416
417
418
419
420
# 6 851 TS=("aflibercept" or "eylea*" or "zaltrap*" or "trapeye*" or "trap-eye*" or
"862111-32-8" or "862111328" or "8621-11-328" or "862111-328" or "862-111-328")
# 5 46,057 #4 OR #3 OR #2 OR #1
Indexes=SCI-EXPANDED, CPCI-S Timespan=All years
# 4 17,132 TS=("AMD" or "wAMD" or "GAMD" or "ARMD" or "wARMD" or
"CNV" or "mCNV" or "nAMD")
# 3 95 TS=("macula*" NEAR/3 "lutea")
# 2 34,360 TS=(("macula*" or "retina*" or "sub-retina*" or "choroid*")
NEAR/3 ("degener*" or "neovascula*" or "neo-vascula*"))
# 1 5,741 TS="maculopath*"
40
421
422
423
424
425
426
427
428
429
430
431
432
A.5 BIOSIS
A.5.1 BIOSIS Citation Index- Science (Web of Knowledge, Thompson Reuters; 1969- 2013-08-23). Searched 28/08/13
# 12 2,596 #11 AND #5
# 11 51,980 #10 OR #9 OR #8 OR #7 OR #6
# 10 177 TS=("aflibercept" or "eylea*" or "zaltrap*" or "trapeye*" or "trap-eye*" or
"862111-32-8" or "862111328" or "8621-11-328" or "862111-328" or "862-111-328")
# 9 14,772 TS=("verteporfin" or "visudyne*" or "benzoporphyrin" or
"porphyrin" or "129497-78-5" or "129497785" or "129497-785" or "129-497-785" or
"1294-97-785")
# 8 34,530 TS=("photodynamic*" or "photo-dynamic*" or "phototherap*" or
"photo-therap*" or "photosensiti*" or "photo-sensiti*" or "photochemotherap*" or
"photo-chemotherap*" or "pdt")
# 7 5,575 TS=("bevacizumab" or "avastin*" or "altuzan*" or "216974-75-3" or
"216974753" or "216974-753" or "216-974-753" or "2169-74-753")
# 6 1,047 TS=("ranibizumab" or "lucentis*" or "rhufab*" or "347396-82-1" or
"347396821" or "347396-821" or "347-396-821" or "3473-96-821")
# 5 31,702 #4 OR #3 OR #2 OR #1
# 4 11,465 TS=("AMD" or "wAMD" or "GAMD" or "ARMD" or "wARMD" or
"CNV" or "mCNV")
# 3 68 TS=("macula*" NEAR/3 "lutea")
# 2 25,418 TS=(("macula*" or "retina*" or "sub-retina*" or "choroid*")
NEAR/3 ("degener*" or "neovascula*" or "neo-vascula*"))
# 1 2,639 TS="maculopath*"
A.5.2 BIOSIS Citation Index (Web of Science, Thompson Reuters; 1969- 2016-02-29). Searched 1/3/16
Indexes=BCI Timespan=All years
# 13 3,335 #12 AND #5
41
433
434
435
436
437
438
439
440
441
442
443
444
445
446
447
448
449
450
451
452
453
454
455
456
457
458
459
460
461
462
463
464
465
# 12 60,362 #11 OR #10 OR #9 OR #8 OR #7 OR #6
# 11 368 TS=(“fovista” or “E10030” or “anti-PDGF” or “antiPDGF” or "anti-
platelet derived growth factor*" or "antiplatelet derived growth factor*" or
“pegpleranib”)
# 10 572 TS=("aflibercept" or "eylea*" or "zaltrap*" or "trapeye*" or "trap-eye*" or
"862111-32-8" or "862111328" or "8621-11-328" or "862111-328" or "862-111-328")
# 9 16,176 TS=("verteporfin" or "visudyne*" or "benzoporphyrin" or
"porphyrin" or "129497-78-5" or "129497785" or "129497-785" or "129-497-785" or
"1294-97-785")
# 8 38,478 TS=("photodynamic*" or "photo-dynamic*" or "phototherap*" or
"photo-therap*" or "photosensiti*" or "photo-sensiti*" or "photochemotherap*" or
"photo-chemotherap*" or "pdt")
# 7 7,989 TS=("bevacizumab" or "avastin*" or "altuzan*" or "216974-75-3" or
"216974753" or "216974-753" or "216-974-753" or "2169-74-753")
# 6 1,844 TS=("ranibizumab" or "lucentis*" or "rhufab*" or "347396-82-1" or
"347396821" or "347396-821" or "347-396-821" or "3473-96-821")
# 5 37,967 #4 OR #3 OR #2 OR #1
# 4 14,706 TS=("AMD" or "wAMD" or "GAMD" or "ARMD" or "wARMD" or
"CNV" or "mCNV" or "nAMD")
# 3 81 TS=("macula*" NEAR/3 "lutea")
# 2 30,249 TS=(("macula*" or "retina*" or "sub-retina*" or "choroid*")
NEAR/3 ("degener*" or "neovascula*" or "neo-vascula*"))
# 1 2,954 TS="maculopath*"
A.6 ECONLIT
A.6.1 Econlit (OvidSP, 1961 to July 2013). Searched 28/08/13
1 maculopath$.ti,ab. (0)
42
466
467
468
469
470
471
472
473
474
475
476
477
478
479
480
481
482
483
484
485
486
487
488
489
490
491
492
493
494
495
2 ((macula$ or retina$ or sub-retina$ or choroid$) adj3 (degener$ or neovascula$
or neo-vascula$)).ti,ab. (2)
3 (macula$ adj3 lutea).ti,ab. (0)
4 (AMD or wAMD or GAMD or ARMD or wARMD or CNV or mCNV).ti,ab. (17)
5 1 or 2 or 3 or 4 (18)
A.6.2 Econlit (OvidSP, 1961 to Jan 2016). Searched 28/02/16
1 maculopath$.ti,ab. (0)
2 ((macula$ or retina$ or sub-retina$ or choroid$) adj3 (degener$ or neovascula$
or neo-vascula$)).ti,ab. (3)
3 (macula$ adj3 lutea).ti,ab. (0)
4 (AMD or wAMD or GAMD or ARMD or wARMD or CNV or mCNV or
nAMD).ti,ab. (22)
5 or/1-4 (23)
A.7 CEA REGISTRY
A.7.1 CEA Registry (https://research.tufts-nemc.org/cear4/Home.aspx) Searched 28/08/13
maculopathy – 0 results
macular degeneration – 29 results (2 added to EndNote, 27 duplicates)
retinal degeneration – 0 results
retinal neovascularisation – 0 results
retinal neovascularization – 0 results
macula lutea – 0 results
choroidal neovascularization - 14 results (1 added to EndNote, 13 duplicates)
choroidal neovascularisation - 2 results (0 added to EndNote, 2 duplicates)
A.7.2 CEA Registry (https://research.tufts-nemc.org/cear4/) Searched 29/2/16
43
496
497
498
499
500
501
502
503
504
505
506
507
508
509
510
511
512
513
514
515
516
517
518
519
520
521
522
523
524
525
526
527
528
529
maculopathy – 1 result
macular – 46 results
retinal – 15 results
macula– 46 results (same as macular)
choroidal – 17 results
A.8 HEED
A.8.1 HEED (Wiley InterScience) Searched 28/08/13
AX=maculopath* 3
AX='macular degeneration' within 3 87
AX='retinal degeneration' within 3 0
AX='macula lutea' within 3 0
AX='choroidal neovascularization' within 3 15
AX='choroidal neovascularisation' within 3 6
AX='retinal neovascularization' within 3 1
AX='retinal neovascularisation' within 3 1
AX=AMD or wAMD or GAMD or ARMD or wARMD or CNV or mCNV 61
CS=1 OR 2 OR 3 OR 4 OR 5 OR 6 OR 7 OR 8 OR 9 119
A.8.2 HEED (Wiley InterScience) Update search
This database is no longer available to search.
A.9 FDA WEBSITE
A.9.1 FDA website (http://www.fda.gov/) Searched 02/09/13
44
530
531
532
533
534
535
536
537
538
539
540
541
542
543
544
545
546
547
548
549
550
551
552
553
554
555
556
557
558
559
560
Searched the following terms separately using the drugs @ FDA search box
[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm]:
lucentis
avastin
eylea
verteporfin
Results were scanned and 18 relevant records were downloaded.
45
561
562
563
564
565
566
567
568
569
570
A.9.2 FDA website (http://www.fda.gov/) Searched 1/3/2016
Searched the following terms separately using the drugs @ FDA search box
[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm] and limiting to
documents with dates since 02/09/2013 (last search date).
Fovista – 0 records
Pegpleranib – 0 records
Lucentis
3 label changes since 2013
Final current label downloaded
Avastin
8 label changes since 2013
Final current label downloaded
Summary review for regulatory action downloaded
Eylea (aflibercept)
5 label changes since 2013
Final current label downloaded
ZIV-aflibercept – 2 label changes
Final current label downloaded
Verteporfin
2 label changes since 2013 but no new label issued
A.10 NICE WEBSITE
A.10.1 NICE website Searched 03/09/13
Searched the following terms separately using the NICE site search engine
[http://www.nice.org.uk/]
age-related macular degeneration - results filtered to ‘guidance’
46
571
572
573
574
575
576
577
578
579
580
581
582
583
584
585
586
587
588
589
590
591
592
593
594
595
596
597
598
599
600
601
602
Following results filtered to ‘guidance’ and ‘eye diseases’
lucentis
ranibizumab
rhufab
avastin
bevacizumab
altuzan
eylea
aflibercept
trap-eye
trapeye
zaltrap
verteporfin
visudyne
benzoporphyrin
porphyrin
Results were scanned and 3 relevant records were downloaded.
A.10.2 NICE website Searched 1/3/16
Searched the following terms separately using the NICE site search engine
[http://www.nice.org.uk/]
age-related macular degeneration - results filtered to ‘guidance’. 57 results.
The only downloaded results were those since Sept 2013:
epiretinal brachytherapy – downloaded guidance
pegaptanib – not recommended – no report to download
47
603
604
605
606
607
608
609
610
611
612
613
614
615
616
617
618
619
620
621
622
623
624
625
626
627
628
629
630
631
The results from the following search were filtered to those records in the last three
years:
fovista OR pegpleranib OR lucentis OR ranibizumab OR rhufab OR avastin
OR bevacizumab OR altuzan OR eylea OR aflibercept OR trap-eye OR
tapeye OR zaltrap OR verteporfin OR visudyne OR benzoporphyrin OR
porphyrin
Results were scanned and 0 new relevant records were downloaded.
A.11 AHRQ
A.11.1 AHRQ website Searched 04/09/13
Searched the following terms separately using the AHRQ site search engine
[http://www.ahrq.gov/index.html]
macular degeneration [in title of page]
lucentis
ranibizumab
rhufab
avastin
bevacizumab macular [search with all of the words]
altuzan
eylea
aflibercept
trap-eye
trapeye
48
632
633
634
635
636
637
638
639
640
641
642
643
644
645
646
647
648
649
650
651
652
653
654
655
656
657
658
659
660
661
zaltrap
verteporfin
visudyne
benzoporphyrin
porphyrin
Results were scanned and 4 relevant records were downloaded.
49
662
663
664
665
666
667
668
669
A.11.2 AHRQ website Searched 04/09/13
Searched the following terms separately using the AHRQ site search engine
[http://www.ahrq.gov/index.html]:
macular degeneration [exact phrase, in title of page]
returns NICE guidance Jul 2013 – not downloaded
fovista pegpleranib lucentis ranibizumab rhufab avastin bevacizumab altuzan
eylea aflibercept trap-eye trapeye zaltrap verteporfin visudyne benzoporphyrin
porphyrin [any word, anythwhere in the document]
Results were scanned and 0 additional relevant records were
downloaded.
A.12 CADTH WEBSITE
A.12.1 CADTH website Searched 04/09/13
Searched the following terms separately using the CADTH site search engine
[http://www.cadth.ca/en]:
macular degeneration
lucentis
ranibizumab
rhufab
avastin
bevacizumab
altuzan
eylea
aflibercept
"trap-eye"
50
670
671
672
673
674
675
676
677
678
679
680
681
682
683
684
685
686
687
688
689
690
691
692
693
694
695
696
697
698
699
trapeye
zaltrap
verteporfin
visudyne
benzoporphyrin
porphyrin
Results were scanned and 6 relevant records were downloaded.
A.12.2 CADTH website Searched 1/3/16
Searched the following terms separately using the CADTH site search engine
[http://www.cadth.ca] and looked for publications since Sept 2013:
macular degeneration
downloaded a review on aflibercept
downloaded a review of bevacizumab
downloaded a review of lucentis
downloaded five documents for common drug review of aflibercept
Records were assessed for relevance by an information specialist; five relevant, non
duplicate records were loaded into Endnote.
A.13 CLINICALTRIALS.GOV
A.13.1 ClinicalTrials.gov Searched 04/09/13
The following 3 searches were run separately using ‘Targeted Search’.
Search 1:
51
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708
709
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713
714
715
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718
719
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721
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723
724
725
726
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729
730
Condition field: wet OR "macular degeneration" OR choroidal OR "macula lutea" OR
"retinal degeneration" OR "retina degeneration" OR AMD OR wAMD OR GAMD OR
ARMD OR wARMD OR CNV OR mCNV OR maculopathy OR maculopathies
Intervention field: lucentis OR ranibizumab OR rhufab OR avastin OR bevacizumab
OR altuzan OR eylea OR aflibercept OR trap-eye OR "trap eye" OR trapeye OR
zaltrap OR verteporfin OR visudyne OR benzoporphyrin OR porphyrin
Results = 420
Search 2:
Condition field: wet OR "macular degeneration" OR choroidal OR "macula lutea" OR
"retinal degeneration" OR "retina degeneration" OR AMD OR wAMD OR GAMD OR
ARMD OR wARMD OR CNV OR mCNV OR maculopathy OR maculopathies
Intervention field: photo OR phototherapy OR "photo-therapy" OR phototherapies
OR "photo-therapies" OR photodynamic OR "photo-dynamic" OR
photochemotherapy OR "photo-chemotherapy" OR photochemotherapies OR
"photo-chemotherapies" OR photosensitive OR "photo-sensitive"
Results = 83
Search 3:
Condition field: wet OR "macular degeneration" OR choroidal OR "macula lutea" OR
"retinal degeneration" OR "retina degeneration" OR AMD OR wAMD OR GAMD OR
ARMD OR wARMD OR CNV OR mCNV OR maculopathy OR maculopathies
52
731
732
733
734
735
736
737
738
739
740
741
742
743
744
745
746
747
748
749
750
751
752
753
754
755
756
757
758
759
Intervention field: pdt
Results = 69
53
760
761
762
763
A.13.2 ClinicalTrials.gov Searched 01/03/16
The following 3 searches were run separately using ‘Targeted Search’ in the
Advanced search option.
Search 1:
Condition field: wet OR "macular degeneration" OR choroidal OR "macula lutea" OR
"retinal degeneration" OR "retina degeneration" OR AMD OR wAMD OR GAMD OR
ARMD OR wARMD OR CNV OR mCNV OR maculopathy OR maculopathies
Intervention field: fovista OR pegpleranib OR lucentis OR ranibizumab OR rhufab
OR avastin OR bevacizumab OR altuzan OR eylea OR aflibercept OR trap-eye OR
"trap eye" OR trapeye OR zaltrap OR verteporfin OR visudyne OR benzoporphyrin
OR porphyrin
Results
Records added since 03/09/2013: 192 records
Records updated since 03/09/2013: 369 records
Search 2:
Condition field: wet OR "macular degeneration" OR choroidal OR "macula lutea" OR
"retinal degeneration" OR "retina degeneration" OR AMD OR wAMD OR GAMD OR
ARMD OR wARMD OR CNV OR mCNV OR maculopathy OR maculopathies
Intervention field: photo OR phototherapy OR "photo-therapy" OR phototherapies
OR "photo-therapies" OR photodynamic OR "photo-dynamic" OR
photochemotherapy OR "photo-chemotherapy" OR photochemotherapies OR
"photo-chemotherapies" OR photosensitive OR "photo-sensitive"
Results
Records added since 03/09/2013: 18 records
Records updated since 03/09/2013: 10 records
54
764
765
766
767
768
769
770
771
772
773
774
775
776
777
778
779
780
781
782
783
784
785
786
787
788
789
790
791
792
793
794
795
796
797
Search 3:
Condition field: wet OR "macular degeneration" OR choroidal OR "macula lutea" OR
"retinal degeneration" OR "retina degeneration" OR AMD OR wAMD OR GAMD OR
ARMD OR wARMD OR CNV OR mCNV OR maculopathy OR maculopathies
Intervention field: pdt
Results
Records added since 03/09/2013: 9 records
Records updated since 03/09/2013: 26 records
55
798
799
800
801
802
803
804
805
806
807
808
809
810
A.14 WORLD HEALTH ORGANIZATION INTERNATIONAL CLINICAL TRIALS REGISTRY PLATFORM (WHO ICTRP)
A.14.1 World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) Searched 04/09/13
Searched following using interface at: http://apps.who.int/trialsearch/
macular degeneration OR choroidal neovasc* OR choroidal neo-vasc* OR macula
lutea OR retina degeneration OR retinal degeneration OR AMD OR wAMD OR
GAMD OR ARMD OR wARMD OR CNV OR mCNV OR maculopath* = 904 trials
A.14.2 World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) Searched 01/03/2016
Searched following using interface at: http://apps.who.int/trialsearch/
macular degeneration OR choroidal neovasc* OR choroidal neo-vasc* OR macula
lutea OR retina degeneration OR retinal degeneration OR AMD OR wAMD OR
GAMD OR ARMD OR wARMD OR CNV OR mCNV OR maculopath*
1655 records for 1293 trials (1293 downloaded)
A.15 CURRENT CONTROLLED TRIALS/ ISRCTTN
A.15.1 Current Controlled Trials Searched 06/09/13
Searched International Standard Randomised Controlled Trial Number Register
[http://www.controlled-trials.com/isrctn/] using following terms:
56
811
812
813
814
815
816
817
818
819
820
821
822
823
824
825
826
827
828
829
830
831
832
833
834
835
836
837
838
839
840
841
macular degeneration OR choroidal OR macula lutea OR retina degeneration OR
retinal degeneration OR AMD OR wAMD OR GAMD OR ARMD OR wARMD OR
CNV OR mCNV OR maculopathy OR maculopathies = 75 results
Searched metaRegister of Controlled Trials (mRCT) [http://www.controlled-
trials.com/mrct/] - all registers selected apart from the NIH ClinicalTrials.gov Register
using following terms:
macular degeneration OR choroidal OR macula lutea OR retina degeneration OR
retinal degeneration OR AMD OR wAMD OR GAMD OR ARMD OR wARMD OR
CNV OR mCNV OR maculopathy OR maculopathies = 83 results
A.15.2 Searched International Standard Randomised Controlled Trial Number Register Searched 1/3/16 This register is the current content of Controlled Clinical Trials [http://www.controlled-
trials.com/isrctn/].
It was searched using the following terms:
“macular degeneration” OR choroidal OR “macula lutea” OR “retina degeneration”
OR “retinal degeneration” OR AMD OR wAMD OR GAMD OR ARMD OR wARMD
OR CNV OR mCNV OR maculopathy OR maculopathies OR nAMD
35 results – downloaded to a word document with links
A.16 AMERICAN ASSOCIATION OF OPHTHALMOLOGY (AAO) CONGRESS ABSTRACTS
A.16.1 American Association of Ophthalmology (AAO) congress abstracts Searched 06/09/13
57
842
843
844
845
846
847
848
849
850
851
852
853
854
855
856
857
858
859
860
861
862
863
864
865
866
867
868
869
870
871
872
873
Searched using the Program Search and Meeting Archive
[https://secure.aao.org/apps/MeetingArchive/tabid/433/Default.aspx], limited to years
2009 - 2013 using the following terms.
Lucentis = 14
Ranibizumab = 110
Rhufab = 4
Avastin = 27
Bevacizumab = 144
Altuzan = 4
Eylea = 5
Aflibercept = 11
trap-eye = 15
trapeye = 4
zaltrap = 4
verteporfin = 11
visudyne = 4
benzoporphyrin = 4
porphyrin = 4
photodynamic = 28
pdt = 21
phototherap = 13
photochemo = 4
photo-=4
435 results were downloaded.
58
874
875
876
877
878
879
880
881
882
883
884
885
886
887
888
889
890
891
892
893
894
895
896
897
898
899
900
A.16.2 American Association of Ophthalmology (AAO) congress abstracts Searched 1/3/16
Searched scientific posters at http://aao.scientificposters.com/epsSearchAAO.cfm
limited to 2014 and 2015:
Any type of study design
Search term: fovista
Search term: pegpleranib
RCTs only (downloaded records)
Lucentis
Ranibizumab
Rhufab
Avastin
Bevacizumab
Altuzan
Eylea
Aflibercept
trap-eye
trapeye
zaltrap
verteporfin
visudyne
benzoporphyrin
porphyrin
photodynamic
pdt
phototherapy
photochemotherapy
28 records were downloaded.
59
901
902
903
904
905
906
907
908
909
910
911
912
913
914
915
916
917
918
919
920
921
922
923
924
925
926
927
928
929
930
931
932
933
934
A.17 ASSOCIATION FOR RESEARCH IN VISION AND OPHTHALMOLOGY (ARVO) CONGRESS ABSTRACTS
A.17.1 Association for Research in Vision and Ophthalmology (ARVO) congress abstracts Searched 08/09/13
Searched via the Investigative Ophthalmology & Visual Science (IOVS) database
(holds all ARVO Annual Meeting Abstracts and all IOVS article abstracts, from
February 1962 to the present): [http://www.iovs.org/search.dtl?arvomtgsearch=true]
Searched following in text, abstract, title field; search limited to ARVO Meeting
Abstracts, dates between Jan 2009 and Dec 2013.
("macular degeneration" OR "choroidal neovasc*" OR "choroidal neo-vasc*" OR
"macula lutea" OR "retinal degeneration" OR "retina degeneration" OR AMD OR
wAMD OR GAMD OR ARMD OR wARMD OR CNV OR mCNV OR maculopath*)
AND (lucentis OR ranibizumab OR rhufab OR avastin OR bevacizumab OR altuzan
OR eylea OR aflibercept OR trap-eye OR "trap eye" OR trapeye OR zaltrap OR
verteporfin OR visudyne OR benzoporphyrin OR porphyrin OR photodynamic OR
pdt) = 930 results
("macular degeneration" OR "choroidal neovasc*" OR "choroidal neo-vasc*" OR
"macula lutea" OR "retinal degeneration" OR "retina degeneration" OR AMD OR
wAMD OR GAMD OR ARMD OR wARMD OR CNV OR mCNV OR maculopath*)
AND ("photo-dynamic*" OR photochemo* OR "photo-chemo*" OR phototherap* OR
"photo-therap*") = 1 result (dup of result retrieved in above set – not downloaded]
A.17.2 Association for Research in Vision and Ophthalmology (ARVO) congress abstracts (1/3/16)
60
935
936
937
938
939
940
941
942
943
944
945
946
947
948
949
950
951
952
953
954
955
956
957
958
959
960
961
962
963
964
965
These abstracts are indexed in the databases searched as part of the Web of
Science resources. We carried out an additional search on ALL databases (Web of
science core collection, Biosis citation index, Korean Journal database, medline,
scielo citation index) as follows:
TOPIC: (fovista or E10030 or anti-PDGF or antiPDGF or "anti-platelet derived growth
factor*" or "antiplatelet derived growth factor*" or pegpleranib OR "aflibercept" or
"eylea*" or "zaltrap*" or "trapeye*" or "trap-eye*" or "862111-32-8" or "862111328" or
"8621-11-328" or "862111-328" or "862-111-328 OR "verteporfin" or "visudyne*" or
"benzoporphyrin" or "porphyrin" or "129497-78-5" or "129497785" or "129497-785" or
"129-497-785" or "1294-97-785" OR photodynamic*" or "photo-dynamic*" or
"phototherap*" or "photo-therap*" or "photosensiti*" or "photo-sensiti*" or
"photochemotherap*" or "photo-chemotherap*" or "pdt" OR "bevacizumab" or
"avastin*" or "altuzan*" or "216974-75-3" or "216974753" or "216974-753" or "216-
974-753" or "2169-74-753" OR "ranibizumab" or "lucentis*" or "rhufab*" or "347396-
82-1" or "347396821" or "347396-821" or "347-396-821" or "3473-96-
821") ANDTOPIC: ("AMD" or "wAMD" or "GAMD" or "ARMD" or "wARMD" or "CNV"
or "mCNV" or "nAMD" OR "macula* lutea" OR (("macula*" or "retina*" or "sub-
retina*" or "choroid*") NEAR/3 ("degener*" or "neovascula*" or "neo-vascula*")) OR
maculopathy*)AND PUBLICATION NAME: (IOVS)
Timespan: 2013-2016.
Search language=Auto
205 records were downloaded.
A.18 EUROPEAN SOCIETY OF RETINA SPECIALISTS (EURETINA) CONGRESS ABSTRACTS
A.18.1 European Society of Retina Specialists (EURETINA) congress abstracts Searched 08/09/13
61
966
967
968
969
970
971
972
973
974
975
976
977
978
979
980
981
982
983
984
985
986
987
988
989
990
991
992
993
994
995
996
997
Searched via the EURETINA Abstracts Archive
[http://www.euretina.org/abstracts.asp]
Search functionality limited. Searched following terms in Paper Title:
macular degeneration
choroidal neovascularization
choroidal neovascularisation
macula lutea
retina degeneration
retinal degeneration
AMD
wAMD
GAMD
ARMD
wARMD
CNV
mCNV
maculopathy
maculopathies
347 results were downloaded.
A.18.2 European Society of Retina Specialists (EURETINA) congress abstracts for 2014 and 2015. Searched 1/3/16
Searched via the EURETINA Abstracts Archive
[http://www.euretina.org/abstracts.asp]
62
998
999
1000
1001
1002
1003
1004
1005
1006
1007
1008
1009
1010
1011
1012
1013
1014
1015
1016
1017
1018
1019
1020
1021
1022
1023
1024
1025
Search options were not operational.
Browsed presentation type ‘Free paper’ and within that category browsed sessions:
AMD1
AMD2
New drug treatment
Quick fire free papers sessions 1 to 5
Browsed presentation type ‘Poster’ and within that category browsed session on
AMD.
5 records were downloaded.
15th Euretina conference (2015)
Browsed ‘Free papers’ and within that the following sessions:
AMD1
AMD2
AMD3
New durg treatments and technologies 1 and 2
Browsed ‘Posters’ and within that the following sessions: AMD
9 records were downloaded.
63
1026
1027
1028
1029
1030
1031
1032
1033
1034
1035
1036
1037
1038
1039
1040
1041
1042
1043
1044
1045
1046
1047
1048
1049
1050
1051
A.19 SUPPLEMENTARY SEARCHES UNDERTAKEN FOR PEGAPTANIB TRIALS
Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R)
<1946 to Present>. Searched 17 March 2014
1 (pegaptanib or macugen$ or 222716-86-1 or 2H1PA8H1EN).ti,ab,rn. (514)
2 randomized controlled trial.pt. (367280)
3 controlled clinical trial.pt. (87861)
4 randomized.ab. (287121)
5 placebo.ab. (151535)
6 drug therapy.fs. (1675625)
7 randomly.ab. (208366)
8 trial.ab. (297423)
9 groups.ab. (1329823)
10 or/2-9 (3283177)
11 1 and 10 (391)
12 exp animals/ not humans/ (3901065)
13 11 not 12 (385)
14 remove duplicates from 13 (380)
CENTRAL on the Cochrane Library. Searched 17/03/14
#1 pegaptanib or macugen* or 222716-86-1 or 2H1PA8H1EN in Trials 91
64
1052
1053
1054
1055
1056
1057
1058
1059
1060
1061
1062
1063
1064
1065
1066
1067
1068
1069
1070
1071
1072
1073
1074
1075
1076
1077
APPENDIX 1B: Excluded Records with Reasons for Exclusion
65
1078
1079
1080
1081
1082
1083
1084
1085
1086
1087
1088
1089
1090
1091
Table B.1: Excluded records (94)
ReferenceReason for Exclusion
Abedi F, Wickremasinghe S, Islam AFM, Inglis KM, Guymer RH. Anti-
VEGF treatment in neovascular age-related macular degeneration: a
treat-and-extend protocol over 2 years. Retina. 2014;34(8):1531-8.
Ineligible
study design
Alcon Research. LHA510 Proof-of-Concept Study as a Maintenance
Therapy for Patients With Wet Age-Related Macular Degeneration. In:
ClinicalTrials.gov [internet]. Bethesda. US National Library of
Medicine. 2015. Available from
https://ClinicalTrials.gov/show/NCT02355028. Identifier:
NCT02355028
Trial register
record (no
results at time
of search)
Altaweel MM, Daniel E, Martin DF, Mittra RA, Grunwald JE, Lai MM,
et al. Outcomes of eyes with lesions composed of >50% blood in the
Comparison of Age-related Macular Degeneration Treatments Trials
(CATT). Ophthalmology. 2015;122(2):391-98.e5.
Ineligible
patient
population
Arnold J, Guymer R, Kurstjens N, Markey C. Phase IV ranibizumab
study investigating the extent of retinal fluid resolution in patients with
neovascular age-related macular degeneration (NAMD): The fluid
study [conference abstract]. Clin Experiment Ophthalmol. 2014;
42(Suppl S1): 109. Available from:
http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/638/CN-
01086638/frame.html
Abstract only
- insufficient
information
Australian National University. The RAAMP study. Ranibizumab
versus aflibercept for age-related macular degeneration, using
multifocal objective pupil perimetry. In: Australian New Zealand
Clinical Trials Registry (ANZCTR) [internet]. Sydney. National Health
and Medical Research Council (NHMRC) Clinical Trials Centre -
University of Sydney. 2014. Available from
http://www.anzctr.org.au/ACTRN12614000497606.aspx. Identifier:
Trial register
record (no
results at time
of search)
66
1092
1093
2
ReferenceReason for Exclusion
ACTRN12614000497606
Azienda Ospedaliera Universitaria Integrata. A randomized controlled
multicentre study to assess the non-inferiority of the safety of
bevacizumab compared to ranibizumab administered by intravitreal
injection in patients with macular degeneration or other exudative not
age-related macular. In: EU Clinical Trials Register [internet]. London.
European Medicines Agency. 2014. Available from
https://www.clinicaltrialsregister.eu/ctr-search/search?
query=eudract_number:2013-000133-12. Identifier: EUCTR2013-
000133-12-IT
Trial register
record (no
results at time
of search)
Bakri SJ, Moshfeghi DM, Francom S, Rundle AC, Reshef DS, Lee PP,
et al. Intraocular pressure in eyes receiving monthly ranibizumab in 2
pivotal age-related macular degeneration clinical trials.
Ophthalmology. 2014;121(5):1102-8.
Ineligible
outcomes
Barikian A, Mahfoud Z, Abdulaal M, Safar A, Bashshur ZF. Induction
with intravitreal bevacizumab every two weeks in the management of
neovascular age-related macular degeneration. Am J Ophthalmol.
2015;159(1):131-7.
Dosing study
Bayer HealthCare AG. A randomized, double-masked, sham-
controlled phase 3b/4 study of the efficacy, safety, and tolerability of
intravitreal aflibercept monotherapy compared to aflibercept with
adjunctive photodynamic therapy as indicated in subjects with
polypoidal choroidal vasculopathy (PLANET) - Aflibercept in
polypoidal choroidal vasculopathy. In: EU Clinical Trials Register
[internet]. London. European Medicines Agency. 2014. Available from
https://www.clinicaltrialsregister.eu/ctr-search/search?
query=eudract_number:2013-004464-54. Identifier: 2013-004464-54
Trial register
record (no
results at time
of search)
Bayer, Regeneron Pharmaceuticals. Japanese Treat and Extend
Study of Aflibercept in Neovascular Age-related Macular
Trial register
record (no
673
ReferenceReason for Exclusion
Degeneration. In: ClinicalTrials.gov [internet]. Bethesda. US National
Library of Medicine. 2014. Available from
https://ClinicalTrials.gov/show/NCT02305238. Identifier:
NCT02305238
results at time
of search)
Bayer. Special Drug Use Investigation of EYLEA for Myopic Choroidal
Neovascularization. In: ClinicalTrials.gov [internet]. Bethesda. US
National Library of Medicine. 2014. Available from
https://ClinicalTrials.gov/show/NCT02260687. Identifier:
NCT02260687
Trial register
record (no
results at time
of search)
Bhisitkul RB, Mendes TS, Rofagha S, Enanoria W, Boyer DS, Sadda
SR, et al. Macular atrophy progression and 7-year vision outcomes in
subjects from the ANCHOR, MARINA, and HORIZON studies: the
SEVEN-UP study. Am J Ophthalmol. 2015;159(5):915-24.e2.
Ineligible
study design
Biocad. Safety and Efficacy Study of BCD-021 Compared to
Lucentis® in Patients With Neovascular Wet Age-related Macular
Degeneration. In: ClinicalTrials.gov [internet]. Bethesda. US National
Library of Medicine. 2016. Available from
https://ClinicalTrials.gov/show/NCT02036723. Identifier:
NCT02036723
Trial register
record (no
results at time
of search)
Bioeq GmbH. Efficacy and safety of the biosimilar ranibizumab
FYB201 in comparison to Lucentis in patients with neovascular age-
related macular degeneration (COLUMBUS-AMD). In: EU Clinical
Trials Register [internet]. London. European Medicines Agency. 2015.
Available from https://www.clinicaltrialsregister.eu/ctr-search/search?
query=eudract_number:2015-001961-20. Identifier: EUCTR2015-
001961-20-AT
Trial register
record (no
results at time
of search)
Braun BC, Schneider U, Henrich B, Hatz K, Fuchsjäger-Mayrl G,
Pruente C. Evaluation of Re-Treatment Indications in a Randomized,
Double-masked, Phase IIIb-Study Comparing Lucentis®
Abstract only
- insufficient
information
684
ReferenceReason for Exclusion
Monotherapy versus PDT Combined With Lucentis® in Patients With
Subfoveal Choroidal Neovascularisation [conference abstract]. Invest
Ophthalmol Vis Sci. 2008; 49(13): ARVO E- abstract 1172. Available
from:
http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/673/CN-
00793673/frame.html
Bressler NM, Rosenfeld PJ, Lim JI, Group VIMS. A Phase II Placebo -
Controlled, Double - Masked, Randomized Trial – Verteporfin in
Minimally Classic CNV due to AMD (VIM). Invest Ophthalmol Vis Sci.
2003;44(13):1100.
Abstract only
- insufficient
information
Canadian Agency For Drugs And Technologies In Health (CADTH).
Aflibercept (Eylea - Bayer Inc.) indication: wet age-related macular
degeneration (Structured abstract). HTA Database. 2014; (1):
Available from:
http://onlinelibrary.wiley.com/o/cochrane/clhta/articles/HTA-
32015000167/frame.html
Review of
trials already
included
Canadian Agency for Drugs and Technologies in Health (CADTH).
CDR clinical review report for Aflibercept (Eylea). Ottawa: CADTH;
2015. Available from:
https://www.cadth.ca/sites/default/files/cdr/clinical/SR0361_Eylea_CL
_Report.pdf.
Review of
trials already
included
Canadian Agency for Drugs and Technologies in Health (CADTH).
CDR pharmacoeconomic review report for Aflibercept (Eylea).
Ottawa: Canadian Agency for Drugs and Technologies in Health;
2015. Available from:
https://www.cadth.ca/sites/default/files/cdr/pharmacoeconomic/SR036
1_Eylea_PE_Report.pdf.
Review of
trials already
included
Chakravarthy U, Adamis AP, Cunningham ET, Goldbaum M, Guyer
DR, Katz B, et al. Year 2 efficacy results of 2 randomized controlled
Ineligible
study design
695
ReferenceReason for Exclusion
clinical trials of pegaptanib for neovascular age-related macular
degeneration. Ophthalmology. 2006;113(9):1508-21.
Chakravarthy U, Jaffe GJ. Dual Antagonism of Platelet Derived
Growth Factor (Fovista 1.5 mg) and Vascular Endothelial Growth
Factor (Lucentis 0.5 mg) Results in Reduced Subretinal Fibrosis and
Neovascular Growth. In: Annual Meeting - American Academy of
Opthalmology, Chicago; Tuesday, October 21. 2014. PA092
Retrospective
analysis
Chang TS, Fine JT, Alexander S, Bressler N. Ranibizumab (Lucentis)
Self-Reported Vision Specific Quality of Life Through 12 Months in
Age-Related Macular Degeneration Patients with Minimally Classic or
Occult-with-No-Classic Choroidal Neovascularization in a Phase III
Randomized Clinical Trial [conference presentation]. In: The Macula
Society, San Diego; 2006. 106
Results of
MARINA and
ANCHOR
trials
Ciulla TA, Cuilla TA, Ying G-S, Maguire MG, Martin DF, Jaffe GJ, et
al. Influence of the Vitreomacular Interface on Treatment Outcomes in
the Comparison of Age-Related Macular Degeneration Treatments
Trials. Ophthalmology. 2015;122(6):1203-11.
Ineligible
comparator
Csaky KG, Dugel PU, Pierce AJ, Fries MA, Kelly DS, Danis RP, et al.
Clinical evaluation of pazopanib eye drops versus ranibizumab
intravitreal injections in subjects with neovascular age-related macular
degeneration. Ophthalmology. 2015;122(3):579-88.
Dosing study
for eye drops
Daniel E, Shaffer J, Ying G-S, Grunwald JE, Martin DF, Jaffe GJ, et
al. Outcomes in Eyes with Retinal Angiomatous Proliferation in the
Comparison of Age-Related Macular Degeneration Treatments Trials
(CATT). Ophthalmology. 2016;123(3):609-16.
Ineligible
comparator
Daniel E, Toth CA, Grunwald JE, Jaffe GJ, Martin DF, Fine SL, et al.
Risk of scar in the comparison of age-related macular degeneration
treatments trials. Ophthalmology. 2014;121(3):656-66.
Ineligible
outcomes
706
ReferenceReason for Exclusion
Department of Ophthalmology - Kagawa University Faculty of
Medicine. The switching therapy with Ranibizumab for Exudative Age-
related Macular Degeneration resistant to Aflibercept. In: UMIN
Clinical Trials Registry (UMIN-CTR) [internet]. Tokyo. University of
Tokyo Hospital. 2013. Available from https://upload.umin.ac.jp/cgi-
open-bin/ctr/ctr.cgi?
function=brows&action=brows&type=summary&langua
ge=E&recptno=R000014609. Identifier: JPRN-UMIN000012724
Trial register
record (no
results at time
of search)
Department of Ophthalmology - Kagawa University Faculty of
Medicine. Treatment outcomes in wet age-related macular
degeneration using a Treat-and-Extend regimen. In: UMIN Clinical
Trials Registry (UMIN-CTR) [internet]. Tokyo. University of Tokyo
Hospital. 2015. Available from
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?
function=brows&action=brows&type=summary&langua
ge=E&recptno=R000020961. Identifier: JPRN-UMIN000018106
Trial register
record (no
results at time
of search)
Desai S, Bhisitkul RB, Enoria W, Rofagha S, Boyer DS, Sadda SR, et
al. Visual outcomes and macular atrophy in non-study eyes in
ANCHOR/MARINA subjects (SEVEN-UP Study). Invest Ophthalmol
Vis Sci. 2015;56(7):2836.
Ineligible
study design
Dugel PU, Kunimoto D, Quinlan E, Jamal K, Goldenberg D, Mehta S,
et al. Anti-VEGF resistance in neovascular AMD: Role of PDGF
antagonism. Invest Ophthalmol Vis Sci. 2015;56(7):2826.
Non
comparative
subgroup
analysis
Duke University, Bausch & Lomb Incorporated. Adjunctive
Photodynamic Therapy + Aflibercept vs. Afilbercept Alone for PDA in
NV AMD. In: ClinicalTrials.gov [internet]. Bethesda. US National
Library of Medicine. 2016. Available from
https://ClinicalTrials.gov/show/NCT02457026. Identifier:
Trial register
record (no
results at time
of search)
717
ReferenceReason for Exclusion
NCT02457026
El Gawhara Eye Center - Egypt. Prophylactic Ranibizumab in the
fellow eye in patients with wet type Age Related Macular
Degeneration. In: Australian New Zealand Clinical Trials Registry
[internet]. Sydney. National Health and Medical Research Council
(NHMRC) Clinical Trials Centre - University of Sydney. 2014.
Available from
http://www.anzctr.org.au/ACTRN12614000511639.aspx. Identifier:
ACTRN12614000511639
Trial register
record (no
results at time
of search)
Eldem BM, Muftuoglu G, Topbas S, Cakir M, Kadayifcilar S, Ozmert
E, et al. A randomized trial to compare the safety and efficacy of two
ranibizumab dosing regimens in a Turkish cohort of patients with
choroidal neovascularization secondary to AMD. Acta Ophthalmol.
2015;93(6):e458-64.
Dosing study
Fauser S, Viebahn U, Muether PS. Intraocular and systemic
inflammation-related cytokines during one year of ranibizumab
treatment for neovascular age-related macular degeneration. Acta
Ophthalmol. 2015;93(8):734-8.
Ineligible
study design
Folgar FA, Jaffe GJ, Ying G-S, Maguire MG, Toth CA, Comparison of
Age-Related Macular Degeneration Treatments Trials Research G.
Comparison of optical coherence tomography assessments in the
comparison of age-related macular degeneration treatments trials.
Ophthalmology. 2014;121(10):1956-65.
Ineligible
comparator
Frenkel REP, Fung AE, Shapiro H, Stoilov I. Low luminance vision
improves nearly twice as much as standard vision with ranibizumab
for neovascular age-related macular degeneration. Invest Ophthalmol
Vis Sci. 2015;56(7)
Ineligible
study design
Genentech Inc. Study of the Efficacy and Safety of the Ranibizumab
Port Delivery System for Sustained Delivery of Ranibizumab in
Trial register
record (no
728
ReferenceReason for Exclusion
Patients With Subfoveal Neovascular Age-Related Macular
Degeneration. In: ClinicalTrials.gov [internet]. Bethesda. US National
Library of Medicine. 2015. Available from
https://ClinicalTrials.gov/show/NCT02510794. Identifier:
NCT02510794
results at time
of search)
Gillies M, Hunyor A, Woodcock C, Walsh M, Kurstjens N. Design and
rationale of a clinical trial to measure the development of geographic
atrophy in patients undergoing anti-vascular endothelial growth factor
treatment for neovascular (WET) age-related macular degeneration:
The rival study [conference abstract]. Clin Experiment Ophthalmol.
2014; (Suppl S1): 113. Available from:
http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/868/CN-
01103868/frame.html
Abstract only
- insufficient
information
Grunwald JE, Daniel E, Huang J, Ying G-S, Maguire MG, Toth CA, et
al. Risk of geographic atrophy in the comparison of age-related
macular degeneration treatments trials. Ophthalmology.
2014;121(1):150-61.
Ineligible
outcomes
Grunwald JE, Pistilli M, Ying G-S, Maguire MG, Daniel E, Martin DF,
et al. Growth of geographic atrophy in the comparison of age-related
macular degeneration treatments trials. Ophthalmology.
2015;122(4):809-16.
Ineligible
indication
Hospices Civils de Lyon. Phase II study evaluating the efficacy of
aflibercept for the treatment of choroidal neovascularization
complicating angioid streaks in young subjects: the ASTRID study. In:
EU Clinical Trials Register [internet]. London. European Medicines
Agency. 2015. Available from https://www.clinicaltrialsregister.eu/ctr-
search/search?query=eudract_number:2014-003661-18. Identifier:
EUCTR2014-003661-18-FR
Trial register
record (no
results at time
of search)
Hospices Civils de Lyon. Phase II study evaluating the efficacy of Trial register
739
ReferenceReason for Exclusion
aflibercept for the treatment of inflammatory choroidal
neovascularization in young subjects: the ALINEA study. In: EU
Clinical Trials Register [internet]. London. European Medicines
Agency. 2015. Available from https://www.clinicaltrialsregister.eu/ctr-
search/search?query=eudract_number:2014-003695-23. Identifier:
EUCTR2014-003695-23-FR
record (no
results at time
of search)
Hospital Authority - Hong Kong. A randomised control trial of anti-
VEGF in the Hospital Authority Setting – the AVIHA Trial: a
Neovascular AMD study. In: Chinese Clinical Trial Register [internet].
Chengdu. Chinese University of Hong Kong. 2014. Available from
http://www.chictr.org.cn/showprojen.aspx?proj=4819. Identifier:
ChiCTR-TRC-14004754
Trial register
record (no
results at time
of search)
Ikuno Y, Ohno-Matsui K, Wong TY, Korobelnik J-F, Vitti R, Li T, et al.
Intravitreal Aflibercept Injection in Patients with Myopic Choroidal
Neovascularization: The MYRROR Study. Ophthalmology.
2015;122(6):1220-7.
Ineligible
indication
Intas Biopharmaceuticals. To compare the safety and efficacy of
Ranibizumab of Intas Biopharmaceuticals Ltd. in comparison with
Lucentis in patients of wet Age related Macular Degeneration. In:
Clinical Trials Registry - India [internet]. New Delhi. National Institute
of Medical Statistics. 2013. Available from
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=7625.
Identifier: CTRI/2013/10/004063
Trial register
record (no
results at time
of search)
Kaiser PK, Grp TAPS. Verteporfin therapy of subfoveal choroidal
neovascularization in age-related macular degeneration: 5-year
results of two randomized clinical trials with an open-label extension -
TAP Report No. 8. Graefes Arch Clin Exp Ophthalmol
2006;244(9):1132-42.
Ineligible
study design
Kertes PJ, Sheidow TG, Williams RG, Greve M, Galic IJ, Rampakakis Abstract-
7410
ReferenceReason for Exclusion
E, et al. Canadian Treat-and-Extend Analysis Trial With Ranibizumab
in Patients With Neovascular AMD: Interim Analysis of the
CANTREAT Study. In: Annual Meeting - American Academy of
Ophthalmology, Las Vegas; Monday, November 16. 2015. PO486
insufficient
info. Listed in
CT.gov as
observational
NCT0210373
8. No results
Khanani A, Hill L, Tuomi L. Improvement in visual acuity following
ranibizumab treatment in neovascular age-related macular
degeneration patients with large pigment epithelial detachments: a
subgroup analysis of the HARBOR study [meeting abstract]. Invest
Ophthalmol Vis Sci. 2015;56(7):A5363.
Dosing study
Li J, Sun JH. Ranibizumab with transpupillary thermotherapy for
clinical efficacy in wet age-related macular degeneration. Int Eye Sci.
2014; 14(10): 1744-8. Available from:
http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/614/CN-
01050614/frame.html
Ineligible
comparator
Li XX, Chen YX, Zhang JJ, Xu X, Cheung GM, Wu HL, et al.
Intravitreal aflibercept shows consistent outcomes in Asian and white
patients with wet age-related macular degeneration: novel results
from the SIGHT and VIEW studies. Invest Ophthalmol Vis Sci.
2015;56(7)
Combined
results of
SIGHT and
VIEW
Lloyd Clark W. Long-term Follow-up of Intravitreal Aflibercept Injection
for Neovascular AMD. In: Annual Meeting - American Academy of
Ophthalmology, Chicago; 20 October. 2014. PO534
Open label
extension of
VIEW I
Lotery AJ, Gibson J, Cree AJ, Downes SM, Harding SP, Rogers CA,
et al. Pharmacogenetic associations with vascular endothelial growth
factor inhibition in participants with neovascular age-related macular
degeneration in the IVAN Study. Ophthalmology. 2013;120(12):2637-
43.
Ineligible
outcomes
7511
ReferenceReason for Exclusion
Mahmood S, Roberts SA, Aslam TM, Parkes J, Barugh K, Bishop PN,
et al. Routine versus As-Needed Bevacizumab with 12-Weekly
Assessment Intervals for Neovascular Age-Related Macular
Degeneration: 92-Week Results of the GMAN Trial. Ophthalmology.
2015;122(7):1348-55.
Dosing study
Medizinische Universität Wien. Activity patterns of the cortical optic
area in wet age-related macular degeneration patients [fMRI analysis
of the visual cortex in neovascular age-related macular degeneration].
In: EU Clinical Trials Register [internet]. London. European Medicines
Agency. 2013. Available from https://www.clinicaltrialsregister.eu/ctr-
search/search?query=eudract_number:2012-004758-27. Identifier:
EUCTR2012-004758-27-AT
Trial register
record (no
results at time
of search)
Meredith TA, McCannel CA, Barr C, Doft BH, Peskin E, Maguire MG,
et al. Postinjection endophthalmitis in the comparison of age-related
macular degeneration treatments trials (CATT). Ophthalmology.
2015;122(4):817-21.
Insufficient
information
Mie University Graduate School of Medicine. Randomized controlled
phase IV trial of combination aflibercept and Kallidinogenase for
neovascular age-related macular degeneration. In: UMIN Clinical
Trials Registry (UMIN-CTR) [internet]. Tokyo. University of Tokyo
Hospital. 2013. Available from
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?
function=brows&action=brows&type=summary&langua
ge=E&recptno=R000012529. Identifier: JPRN-UMIN000011703
Trial register
record (no
results at time
of search)
Moorfields Eye Hospital. The LEAVO study. In: ISRCTN Registry
[internet]. London. BioMed Central. 2014. Available from
http://isrctn.com/ISRCTN13623634. Identifier: ISRCTN13623634
Trial register
record (no
results at time
of search)
Nagoya City University Graduate School of Medical Sciences. Study Trial register
7612
ReferenceReason for Exclusion
of efficacy of aflibercept in neovascular age-related macular
degeneration (wAMD) with non-responder of ranibizumab. In: UMIN
Clinical Trials Registry (UMIN-CTR) [internet]. Tokyo. University of
Tokyo Hospital. 2013. Available from https://upload.umin.ac.jp/cgi-
open-bin/ctr/ctr.cgi?
function=brows&action=brows&type=summary&langua
ge=E&recptno=R000012350. Identifier: JPRN-UMIN000010577
record (no
results at time
of search)
Nagoya City University Graduate School of Medical Sciences. Study
of efficacy of aflibercept in neovascular age-related macular
degeneration (wAMD) with refractory of ranibizumab. In: UMIN
Clinical Trials Registry (UMIN-CTR) [internet]. Tokyo. University of
Tokyo Hospital. 2013. Available from https://upload.umin.ac.jp/cgi-
open-bin/ctr/ctr.cgi?
function=brows&action=brows&type=summary&langua
ge=E&recptno=R000012353. Identifier: JPRN-UMIN000010578
Trial register
record (no
results at time
of search)
Novartis Pharma. Comparison of systemic VEGF protein dynamics
following monthly intravitreal injections of 0.5 mg ranibizumab versus
2 mg aflibercept in patients with neovascular (wet) age-related
macular degeneration. In: EU Clinical Trials Register [internet].
London. European Medicines Agency. 2014. Available from
https://www.clinicaltrialsregister.eu/ctr-search/search?
query=eudract_number:2014-001182-27. Identifier: EUCTR2014-
001182-27-DE
Trial register
record (no
results at time
of search)
Novartis Pharma. Efficacy of ranibizumab compared to aflibercept
bimonthly intravitreal injections on retinal thickness stabilityin in
patients with nAMD. In: EU Clinical Trials Register [internet]. London.
European Medicines Agency. 2013. Available from
https://www.clinicaltrialsregister.eu/ctr-search/search?
query=eudract_number:2013-002431-15. Identifier: EUCTR2013-
Trial register
record (no
results at time
of search)
7713
ReferenceReason for Exclusion
002431-15-DE
Novartis Pharmaceuticals. A Comparison of Ranibizumab and
Aflibercept for the Development of Geographic Atrophy in (Wet) AMD
Patients. In: ClinicalTrials.gov [internet]. Bethesda. US National
Library of Medicine. 2014. Available from
https://ClinicalTrials.gov/show/NCT02130024. Identifier:
NCT02130024
Trial register
record (no
results at time
of search)
Novartis Pharmaceuticals. Assess the Efficacy/Safety of Intravitreal
Ranibizumab in People With Vision Loss Due to Choroidal
Neovascularization. In: ClinicalTrials.gov [internet]. Bethesda. US
National Library of Medicine. 2013. Available from
https://ClinicalTrials.gov/show/NCT01840410. Identifier:
NCT01840410
Trial register
record (no
results at time
of search)
Novartis Pharmaceuticals. Efficacy of Ranibizumab Prn Treatment
Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal
Thickness Stability in Patients With NAMD. In: ClinicalTrials.gov
[internet]. Bethesda. US National Library of Medicine. 2013. Available
from https://ClinicalTrials.gov/show/NCT01958918. Identifier:
NCT01958918
Trial register
record (no
results at time
of search)
Novartis Pharmaceuticals. Prospective study of safety and efficacy of
combination therapy using intravitreal triamcinolone acetonide and
ranibizumab versus ranibizumab monotherapy for neovascular age-
related macular degeneration. In: Chinese Clinical Trial Register
[internet]. Chengdu. Chinese University of Hong Kong. 2015.
Available from http://www.chictr.org.cn/showproj.aspx?proj=11249.
Identifier: ChiCTR-ICR-15006619
Trial register
record (no
results at time
of search)
Novartis Pharmaceuticals. Randomized Study for Efficacy and Safety
of Ranibizumab 0.5mg in Treat-extend and Monthly Regimens in
Patients With nAMD. In: ClinicalTrials.gov [internet]. Bethesda. US
Trial register
record (no
results at time
7814
ReferenceReason for Exclusion
National Library of Medicine. 2013. Available from
https://ClinicalTrials.gov/show/NCT01948830. Identifier:
NCT01948830
of search)
Novartis Pharmaceuticals. Systemic VEGF Protein Dynamics
Following Intravitreal Injections of Ranibizumab Versus Aflibercept in
Patients With Neovascular Age-related Macular Degeneration. In:
ClinicalTrials.gov [internet]. Bethesda. US National Library of
Medicine. 2015. Available from
https://ClinicalTrials.gov/show/NCT02257632. Identifier:
NCT02257632
Trial register
record (no
results at time
of search)
Novartis Pharmaceuticals. UNcovering the Difference Between
Ranibizumab and Aflibercept, Focusing on Systemic Anti-VEGF
Effects in Patients With neovascuLar AMD. In: ClinicalTrials.gov
[internet]. Bethesda. US National Library of Medicine. 2014. Available
from https://ClinicalTrials.gov/show/NCT01988662. Identifier:
NCT01988662
Trial register
record (no
results at time
of search)
Ohr Pharmaceutical Inc. Effect of Squalamine Lactate Ophthalmic
Solution, 0.2% in Subjects With Neovascular Age-Related Macular
Degeneration. In: ClinicalTrials.gov [internet]. Bethesda. US National
Library of Medicine. 2015. Available from
https://ClinicalTrials.gov/show/NCT02511613. Identifier:
NCT02511613
Trial register
record (no
results at time
of search)
Patel PJ, Rubin GS, Chen FK, da Cruz L, Tufail A, Investigators
ABCT. Impact of Anti-vascular Endothelial Growth Factor Therapy on
Reading Performance in Age-related Macular Degeneration: A
Randomized Controlled Trial. Invest Ophthalmol Vis Sci.
2015;56(7):4794.
Abstract only
- insufficient
information
Piri N, Ahmadieh H, Taei R, Soheilian M, Karkhaneh R, Lashay A, et
al. Photodynamic Therapy and Intravitreal Bevacizumab with Versus
Ineligible
intervention
7915
ReferenceReason for Exclusion
without Triamcinolone for Neovascular Age-related Macular
Degeneration; a Randomized Clinical Trial. J Ophthalmic Vis Res.
2014;9(4):469-77.
Pistilli M, Ying G-S, Toth CA, Jaffe GJ, Martin DF, Grp CR. Resolution
of Retinal Fluid on Optical Coherence Tomography in the Comparison
of AMD Treatments Trials (CATT). Invest Ophthalmol Vis Sci.
2015;56(7):1657.
Abstract only
- insufficient
information
Pusan National University Hospital. Effect of Intravitreal VEGF-Trap
Eye on Polypoidal Choroidal Vasculopathy. In: ClinicalTrials.gov
[internet]. Bethesda. US National Library of Medicine. 2013. Available
from https://ClinicalTrials.gov/show/NCT01950741. Identifier:
NCT01950741
Trial register
record (no
results at time
of search)
Ramsay CR. Aflibercept solution for injection for the treatment of wet
age-related macular degeneration (ID519) [project record: report
unpublished as yet]. Southampton: NIHR; 2013. Available from:
http://onlinelibrary.wiley.com/o/cochrane/clhta/articles/HTA-
32013000885/frame.html.
Review of
trials already
included
Ranibizumab (Lucentis) in high myopia with neovascularization. Better
short-term visual acuity but serious adverse effects. Prescrire Int.
2015;24(161):151.
Abstract only
- insufficient
information
Rezar S, Sacu S, Eibenberger K, Buehl W, Krall C, Weigert G, et al.
Role of additional dexamethasone treatment for the management of
persistent choroidal neovascularization secondary to age-related
macular degeneration. In: ARVO 2015 Annual Meeting, Denver; 4
May. 2015. 1280, A203
Abstract only
- insufficient
information
Rofagha S, Bhisitkul RB, Boyer DS, Sadda SR, Zhang K, Group S-
US. Seven-year outcomes in ranibizumab-treated patients in
ANCHOR, MARINA, and HORIZON: a multicenter cohort study
Ineligible
study design
8016
ReferenceReason for Exclusion
(SEVEN-UP). Ophthalmology. 2013;120(11):2292-9.
Rofagha S, Bhisitkul RB, Boyer DS, Sadda SR, Zhang K, Grp S-US.
Seven-Year Outcomes in Ranibizumab-Treated Patients in ANCHOR,
MARINA, and HORIZON. Ophthalmology. 2013;120(11):2292-99.
Ineligible
study design
Russo A, Costagliola C, Delcassi L, Romano MR, Semeraro F. A
randomised controlled trial of ranibizumab with and without ketorolac
eyedrops for exudative age-related macular degeneration. Br J
Ophthalmol. 2013;97(10):1273-6.
Ineligible
intervention
Saturnino LTM, Silveira MR, Guerra AA, Acurcio FDA. Efficacy and
Safety of Ranibizumab and Bevacizumab in Treatment for Age
Related Macular Degeneration. Value Health. 2013;16(7):A667-A68.
Abstract only
- insufficient
information
Saviano S, Piermarocchi R, Leon PE, Mangogna A, Zanei A,
Cavarzeran Sc F, et al. Combined therapy with bevacizumab and
photodynamic therapy for myopic choroidal neovascularization: A
one-year follow-up controlled study. insert correct info here.
2014;7(2):335-9.
Ineligible
study design
Schmidt-Erfurth U, Waldstein SM, Deak G-G, Kundi M, Simader C.
Pigment epithelial detachment followed by retinal cystoid
degeneration leads to vision loss in treatment of neovascular age-
related macular degeneration. Ophthalmology. 2015;122(4):822-32.
Ineligible
outcomes
Selim A, Kocak N, Aslankara H, Kaynak S. Comparative study of
photodynamic therapy monotherapy versus triple management in age-
related macular degeneration. Turk J Med Sci. 2014;44(5):889-95.
Ineligible
intervention
Shi X, Wei W, Zhang C. Intravitreal ranibizumab therapy versus
photodynamic therapy for idiopathic choroidal neovascularization: a
comparative study on visual acuity, retinal and choroidal thickness.
Chin Med J. 2014;127(12):2279-85.
Ineligible
study design
Simader C, Ritter M, Bolz M, Deak GG, Mayr-Sponer U, Golbaz I, et Dosing study
8117
ReferenceReason for Exclusion
al. Morphologic parameters relevant for visual outcome during anti-
angiogenic therapy of neovascular age-related macular degeneration.
Ophthalmology. 2014;121(6):1237-45.
Sin M, Chrapek O, Karhanova M, Pracharova Z, Langova K, Rehak J.
Progression of macular atrophy after PDT combined with the COX-2
inhibitor Nabumetone in the treatment of neovascular ARMD. Biomed
Pap Med Fac Univ Palacky Olomouc Czech Repub. 2014;158(1):138-
43.
Ineligible
intervention
Singer MA. Safety of Intravitreal Aflibercept Injection From RE-VIEW
in Neovascular AMD. In: Annual Meeting - American Academy of
Ophthalmology, Las Vegas; 15 November. 2015. PO212
Abstract only
- extension of
VIEW trials
Sizmaz S, Kucukerdonmez C, Kal A, Pinarci EY, Canan H, Yilmaz G.
Retinal and choroidal thickness changes after single anti-VEGF
injection in neovascular age-related macular degeneration:
ranibizumab vs bevacizumab. Eur J Ophthalmol. 2014;24(6):904-10.
Ineligible
outcomes
St. Michael's Hospital Toronto. Intravitreal Aflibercept in Wet Age
Related Macular Degeneration Patients With an Incomplete Response
to Routine Ranibizumab Injections. In: ClinicalTrials.gov [internet].
Bethesda. US National Library of Medicine. 2014. Available from
https://ClinicalTrials.gov/show/NCT02002377. Identifier:
NCT02002377
Trial register
record (no
results at time
of search)
Sulzbacher F, Sacu S, Roberts PK, Munk MR, Kroh ME, Kaider A, et
al. Relationship of Retinal morphology and Sensitivity in Neovascular
Age-related Macular Degeneration (NAMD). Comparision of
Ranibizumab versus Aflibercept treatment over 1 year. Invest
Ophthalmol Vis Sci. 2015;56(7):A1521.
Ineligible
study design
Tyrogenex. X-82 to Treat Age-related Macular Degeneration. In:
ClinicalTrials.gov [internet]. Bethesda. US National Library of
Medicine. 2015. Available from
Trial register
record (no
results at time
8218
ReferenceReason for Exclusion
https://ClinicalTrials.gov/show/NCT02348359. Identifier:
NCT02348359of search)
University Health Network Toronto. Intraocular Cytokines in Non-
responders to Ranibizumab Treatment for Neovascular AMD. In:
ClinicalTrials.gov [internet]. Bethesda. US National Library of
Medicine. 2014. Available from
https://ClinicalTrials.gov/show/NCT02218177. Identifier:
NCT02218177
Trial register
record (no
results at time
of search)
Willoughby AS, Ying G-S, Toth CA, Maguire MG, Burns RE, Grunwald
JE, et al. Subretinal Hyperreflective Material in the Comparison of
Age-Related Macular Degeneration Treatments Trials.
Ophthalmology. 2015;122(9):1846-53.e5.
Ineligible
comparator
Zehetner C, Kralinger MT, Modi YS, Waltl I, Ulmer H, Kirchmair R, et
al. Systemic levels of vascular endothelial growth factor before and
after intravitreal injection of aflibercept or ranibizumab in patients with
age-related macular degeneration: a randomised, prospective trial.
Acta Ophthalmol. 2015;93(2):e154-9.
Ineligible
outcomes
83
1094
1095
19
References
1. Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006;355(14):1432-44.
2. Menon G, Chandran M, Sivaprasad S, Chavan R, Narendran N, Yang Y. Is it necessary to use three mandatory loading doses when commencing therapy for neovascular age-related macular degeneration using bevacizumab? (BeMOc Trial). Eye. 2013;27(8):959-63.
3. Biswas P, Sengupta S, Choudhary R, Home S, Paul A, Sinha S. Comparative role of intravitreal ranibizumab versus bevacizumab in choroidal neovascular membrane in age-related macular degeneration. Indian J Ophthalmol. 2011;59(3):191-6.
4. Schauwvlieghe AME, Dijkman G, Hooymans JM, Verbraak FD, Hoyng CB, Dijkgraaf MGW, et al. Ranibizumab versus Bevacizumab in the Netherlands: Comparing the Efficacy of Bevacizumab to Ranibizumab in Patients with Exudative Age-Related Macular Degeneration - The BRAMD Study. Ophthalmologica. 2013;230:2-3.
5. CATT Research Group, Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, et al. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011;364(20):1897-908.
6. London NJ, Fung AE, Dugel PU, Bakri SJ, Shaw RE, Miner JL, et al. A Prospective Evaluation of Ranibizumab for Retinal Pigment Epithelial Detachments in Neovascular Age-related Macular Degeneration. Invest Ophthalmol Vis Sci. 2009;50(5):2379.
7. El-Mollayess GM, Mahfoud Z, Schakal AR, Salti HI, Jaafar D, Bashshur ZF. Fixed-Interval Versus OCT-Guided Variable Dosing of Intravitreal Bevacizumab in the Management of Neovascular Age-Related Macular Degeneration: A 12-Month Randomized Prospective Study. American Journal of Ophthalmology. 2012;153(3):481-9.e1.
8. Lushchyk T, Amarakoon S, Martinez-Ciriano JP, van den Born LI, Baarsma GS, Missotten T. Bevacizumab in age-related macular degeneration: a randomized controlled trial on the effect of injections every 4weeks, 6weeks and 8weeks. Acta Ophthalmol (Oxf). 2013;91(6):e456-61.
9. Tano Y, Ohji M, Group E-IS. EXTEND-I: safety and efficacy of ranibizumab in Japanese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. Acta ophthalmologica. 2010;88(3):309-16.
10. Heier JS, Boyer DS, Ciulla TA, Ferrone PJ, Jumper JM, Gentile RC, et al. Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration: year 1 results of the FOCUS Study. Archives of ophthalmology. 2006;124(11):1532-42.
11. Kodjikian L, Souied EH, Mimoun G, Mauget-Faysse M, Behar-Cohen F, Decullier E, et al. Ranibizumab versus Bevacizumab for Neovascular Age-related
84
1096
1097
109810991100
1101110211031104
1105110611071108
11091110111111121113
111411151116
1117111811191120
11211122112311241125
1126112711281129
113011311132
1133113411351136
11371138
20
Macular Degeneration: Results from the GEFAL Noninferiority Randomized Trial. Ophthalmology. 2013;120(11):2300-9.
12. Giustolisi R, Fantozzi N, Staltari M, Marchiori J, Mastrangelo O, Marcucci R, et al. Combined intravitreal ranibizumab and verteporfin photodynamic therapy versus ranibizumab alone for the treatment of age-related macular degeneration. Digit. 2011;17(3):23-30.
13. Busbee BG, Ho AC, Brown DM, Heier JS, Suner IJ, Li Z, et al. Twelve-month efficacy and safety of 0.5 mg or 2.0 mg ranibizumab in patients with subfoveal neovascular age-related macular degeneration. Ophthalmology. 2013;120(5):1046-56.
14. Chakravarthy U, Harding, S. P., Rogers, C. A., Downes, S. M., Lotery, A. J., Wordsworth, S., & Reeves, B. C. Ranibizumab versus bevacizumab to treat neovascular age-related macular degeneration: One-year findings from the IVAN randomized trial. Ophthalmology. 2012(119):1399-411.
15. Bashshur ZF, Schakal A, Hamam RN, El Haibi CP, Jaafar RF, Noureddin BN. Intravitreal bevacizumab vs verteporfin photodynamic therapy for neovascular age-related macular degeneration. Archives of ophthalmology. 2007;125(10):1357-61.
16. Berg K, Hadzalic E, Gjertsen I, Forsaa V, Berger LH, Kinge B, et al. Ranibizumab or Bevacizumab for Neovascular Age-Related Macular Degeneration According to the Lucentis Compared to Avastin Study Treat-and-Extend Protocol: Two-Year Results. Ophthalmology. 2016;123(1):51-9.
17. Schmid-Kubista KE, Krebs I, Gruenberger B, Zeiler F, Schueller J, Binder S. Systemic bevacizumab (Avastin) therapy for exudative neovascular age-related macular degeneration. The BEAT-AMD-Study. British Journal of Ophthalmology. 2009;93(7):914-9.
18. Krebs I, Vecsei Marlovits V, Bodenstorfer J, Glittenberg C, Ansari Shahrezaei S, Ristl R, et al. Comparison of Ranibizumab monotherapy versus combination of Ranibizumab with photodynamic therapy with neovascular age-related macular degeneration. Acta Ophthalmol (Oxf). 2013;91(3):e178-83.
19. Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355(14):1419-31.
20. Moon E, al e. Monthly versus PRN ranibizumab for neovascular AMD: a randomized phase 2 open-label study. Invest Ophthalmol Vis Sci 2011;52(6):Article ID 2349645.
21. Ophthotech Corporation, cartographer A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration. Bethesda: US National Library of Medicine; 2010.
22. Subramanian ML, Abedi G, Ness S, Ahmed E, Fenberg M, Daly MK, et al. Bevacizumab vs ranibizumab for age-related macular degeneration: 1-year outcomes of a prospective, double-masked randomised clinical trial. Eye. 2010;24(11):1708-15.
23. Wykoff CC, Croft DE, Brown DM, Wang R, Payne JF, Clark L, et al. Prospective Trial of Treat-and-Extend versus Monthly Dosing for Neovascular Age-
85
11391140
1141114211431144
1145114611471148
1149115011511152
115311541155
1156115711581159
1160116111621163
1164116511661167
116811691170
117111721173
117411751176
1177117811791180
11811182
21
Related Macular Degeneration: TREX-AMD 1-Year Results. Ophthalmology. 2015;122(12):2514-22.
24. Heier JS. VIEW 1 and VIEW 2 investigators. 96 weeks results from the VIEW 1 and VIEW 2 studies: Intravitreal aflibercept injection versus ranibizumab for neovascular AMD shows sustained improvements in visual acuity. ARVO 2012 Available at: http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=14c6c603-88a2-46c6-8de1-ac24d9f71e9f&cKey=d2fd93bb-6f0e-4a1b-bdc0-b76e87b5b90a&mKey=%7bF0FCE029-9BF8-4E7C-B48E-9FF7711D4A0E%7d..
25. Higgins J, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0. London: Cochrane; updated March 2011.
26. Hodgson R, Barata T, Fleetwood K, Edwards M, Glanville J. Indirect treatment comparison of lucentis for wet age related macular degeneration. York: York Health Economics Consortium Ltd., 2014 June. Report No.
27. Ophthotech Corporation, cartographer Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD. Bethesda: US National Library of Medicine; 2014.
86
11831184
118511861187118811891190
11911192
119311941195
1196119711981199
1200
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