CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 304 enrolled
Drug / intervention
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01482910
NCT01482910Phase 3Completed
CompareCT.gov

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

Bayer·interventional·Posted Dec 1, 2011·Updated Nov 4, 2016

In Brief

A Phase 3 clinical trial evaluating Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) and Visudyne for Macular Degeneration. Completed, enrolled 304 participants across 14 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Degeneration
CountriesChina
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 1, 2011
Enrollment StartDec 1, 2011
Primary CompletionMar 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.6 years ago

Interventions

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)biological

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.

Visudynedrug

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.