VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)
|ClinicalTrials.gov Identifier: NCT01482910|
Recruitment Status : Completed
First Posted : December 1, 2011
Results First Posted : March 13, 2015
Last Update Posted : November 4, 2016
This study will assess the efficacy and safety of intravitreally (IVT), i.e. directly into the eye administered VEGF Trap-Eye compared with photodynamic therapy (PDT) on visual function in Chinese subjects with age-related neovascular or "wet" age-related macular degeneration.
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.
|Condition or disease||Intervention/treatment||Phase|
|Macular Degeneration||Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) Drug: Visudyne||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||304 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-masked, Photodynamic Therapy-controlled Phase-3 Study of the Efficacy, Safety, and Tolerability of Intravitreal VEGF Trap-Eye in Chinese Subjects With Neovascular Age-Related Macular Degeneration|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||August 2014|
Experimental: 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.
Biological: 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.
Active Comparator: 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.
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.
- Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 - Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and at week 28 ]Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.
- Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 - LOCF [ Time Frame: At week 28 ]Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482910
|Guangzhou, Guangdong, China, 510060|
|Changsha, Hunan, China, 410011|
|Xi'an, Shaanxi, China, 710032|
|Qingdao, Shandong, China|
|Chengdu, Sichuan, China, 610041|
|Hangzhou, Zhejiang, China, 310003|
|Hangzhou, Zhejiang, China, 310009|
|Wenzhou, Zhejiang, China|
|Beijing, China, 100044|
|Beijing, China, 100083|
|Beijing, China, 100730|
|Beijing, China, 2000080|
|Tianjin, China, 300384|
|Study Director:||Bayer Study Director||Bayer|