VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)
NCT ID: NCT01482910
Last Updated: 2016-11-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
304 participants
INTERVENTIONAL
2011-12-31
2014-08-31
Brief Summary
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Subjects will be randomized in a 3:1 ratio to either receive VEGF Trap-Eye or PDT. Both treatment groups will receive the other treatment as a sham procedure.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Aflibercept injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Participants in the VEGF Trap-Eye group received intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks for an overall treatment period of 48 weeks. Additionally, sham PDT treatments was administered as needed.
PDT treatments
Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
Visudyne
Participants in the PDT group (Visudyne group) received Visudyne as needed. Additionally, sham IVT injections was administered until week 28. Thereafter, subjects in the PDT group received active (= no sham) VEGF Trap-Eye treatment until week 48.
Interventions
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Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Participants in the VEGF Trap-Eye group received intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks for an overall treatment period of 48 weeks. Additionally, sham PDT treatments was administered as needed.
Visudyne
Participants in the PDT group (Visudyne group) received Visudyne as needed. Additionally, sham IVT injections was administered until week 28. Thereafter, subjects in the PDT group received active (= no sham) VEGF Trap-Eye treatment until week 48.
Eligibility Criteria
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Inclusion Criteria
* Men and women ≥ 50 years of age.
* Active predominantly classic subfoveal choroidal neovascularization (CNV) lesions secondary to wAMD (wet Age-Related Macular Degeneration)
* BCVA (best corrected visual acuity) of 20/40 to 20/320 in the study eye
Exclusion Criteria
* Presence of CNV with an origin other than wAMD
* Any prior ocular or systemic treatment or surgery for wAMD, except dietary supplements or vitamins
50 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Guangzhou, Guangdong, China
Changsha, Hunan, China
Xi'an, Shaanxi, China
Qingdao, Shandong, China
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Wenzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Shanghai, , China
Tianjin, , China
Countries
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Other Identifiers
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13406
Identifier Type: -
Identifier Source: org_study_id