CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 406 enrolled
Drug / intervention
VEGF Trap-Eye (BAY86-5321) +2 morebiological
Likely dose
VEGF Trap-Eye (BAY86-5321) 2mgfrom 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/NCT01331681
NCT01331681Phase 3Completed
CompareCT.gov

A Randomized, Double Masked, Active Controlled, Phase III Study of the Efficacy and Safety of Repeated Doses of Intravitreal VEGF Trap-Eye in Subjects With Diabetic Macular Edema

Bayer·interventional·Posted Apr 8, 2011·Updated Nov 27, 2023

In Brief

A Phase 3 clinical trial evaluating VEGF Trap-Eye (BAY86-5321) and Macular Laser Photocoagulation (Control) for Diabetes Mellitus and Macular Edema. Completed, enrolled 406 participants across 73 sites in 11 countries.

Detailed Summary

To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Macular Edema
CountriesAustralia, Austria, Czechia, Denmark, France, Germany, Hungary, Italy, Japan, Poland, Spain
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 8, 2011
Enrollment StartMay 9, 2011
Primary CompletionJun 3, 2013
Study CompletionMar 30, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.2 years ago

Interventions

VEGF Trap-Eye (BAY86-5321)biological

Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).

VEGF Trap-Eye (BAY86-5321)biological

Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).

Macular Laser Photocoagulation (Control)procedure

Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.