CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 177 enrolled
Drug / intervention
Aflibercept Injection (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/NCT01012973
NCT01012973Phase 3Completed
CompareCT.gov

A Randomized, Double-masked, Sham-controlled Phase 3 Study of the Efficacy, Safety and Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)

Bayer·interventional·Posted Nov 13, 2009·Updated Nov 3, 2014

In Brief

A Phase 3 clinical trial evaluating Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) and Sham treatment for Retinal Vein Occlusion. Completed, enrolled 177 participants across 73 sites in 10 countries.

Detailed Summary

To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetinal Vein Occlusion
CountriesAustralia, Austria, France, Germany, Hungary, Italy, Japan, Latvia, Singapore, South Korea
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 13, 2009
Enrollment StartOct 1, 2009
Primary CompletionFeb 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.6 years ago

Interventions

Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)biological

Intravitreal injection. Weeks 0 to 20 of Aflibercept Injection every 4 weeks; Weeks 24 to 52 every 4 weeks PRN (pro re nata, on demand); plus additional on Week 60 and 68.

Sham treatmentother

Sham treatment. Weeks 0 to 52 sham treatment every 4 weeks; plus additional on Week 60 and 68.