CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 381 enrolled
Drug / intervention
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) +2 morebiological
Likely dose
Aflibercept (Eylea, 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/NCT01783886
NCT01783886Phase 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 Feb 5, 2013·Updated May 12, 2016

In Brief

A Phase 3 clinical trial evaluating Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) and Macular Laser Photocoagulation for Macular Edema. Completed, enrolled 381 participants across 25 sites in 4 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--
ConditionsMacular Edema
CountriesChina, Hong Kong, Russia, South Korea
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 5, 2013
Enrollment StartFeb 1, 2013
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.4 years ago

Interventions

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

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

Aflibercept (Eylea, 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 Photocoagulationprocedure

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.