At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 221 enrolled
Drug / intervention
Intravitreal Aflibercept Injection +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, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema (DME)
In Brief
A Phase 2 clinical trial evaluating Laser Photocoagulation and Intravitreal Aflibercept Injection for Diabetic Macular Edema. Completed, enrolled 221 participants across 47 sites in 3 countries.
Detailed Summary
This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesAustria, Canada, United States
CollaboratorsBayer
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartDec 2008
Primary CompletionDec 2009
Study CompletionSep 2010
TodayJul 2026
First PostedNov 11, 2008
Enrollment StartDec 1, 2008
Primary CompletionDec 1, 2009
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.6 years ago
Interventions
Laser Photocoagulationprocedure
laser every 16 weeks as needed
Intravitreal Aflibercept Injectiondrug