At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 466 enrolled
Drug / intervention
Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) +1 moredrug
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.
A Double-Masked, Randomized, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema
In Brief
A Phase 3 clinical trial evaluating Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) and Macular Laser Photocoagulation for Diabetic Macular Edema. Completed, enrolled 466 participants across 51 sites.
Detailed Summary
The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involvement.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesUnited States
CollaboratorsBayer
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedJun 2011
Primary CompletionJan 2013
Study CompletionNov 2014
TodayJul 2026
First PostedJun 1, 2011
Enrollment StartMay 1, 2011
Primary CompletionJan 1, 2013
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.1 years ago
Interventions
Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)drug
Macular Laser Photocoagulationprocedure
Laser therapy