At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 463 enrolled
Drug / intervention
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)drug
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.
An Open-label, Randomized, Active-controlled, Parallel-group, Phase-3b Study of the Efficacy, Safety, and Tolerability of Three Different Treatment Regimens of 2 mg Aflibercept Administered by Intravitreal Injections to Subjects With Diabetic Macular Edema (DME)
In Brief
A Phase 3 clinical trial evaluating Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) for Macular Edema. Completed, enrolled 463 participants across 64 sites in 14 countries.
Detailed Summary
To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different intravitreal (IVT) treatment regimens to participants with DME pretreated with 2 mg aflibercept every 8 weeks after 5 initial monthly injections for approximately 1 year or more (according to the EU label for the first year of treatment)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Edema
CountriesAustria, Canada, Czechia, France, Germany, Hungary, Italy, Lithuania, Poland, Portugal, Slovakia, Spain, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartNov 2016
Primary CompletionNov 2018
Study CompletionSep 2019
TodayJul 2026
First PostedJun 30, 2016
Enrollment StartNov 16, 2016
Primary CompletionNov 13, 2018
Study CompletionSep 24, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 10.0 years ago
Interventions
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)drug