At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 153 enrolled
Drug / intervention
Aflibercept +2 morebiological
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.
Phase 1b/2a Study of OPT-302 in Combination With Aflibercept for Persistent Central-involved Diabetic Macular Edema
In Brief
A Phase 2 clinical trial evaluating Aflibercept, OPT-302, and 1 other intervention for Diabetic Macular Edema. Completed, enrolled 153 participants across 53 sites in 4 countries.
Detailed Summary
A two part, multi-center study consisting of a Phase 1b open label, sequential dose escalation followed by a Phase 2a randomized, double-masked, dose expansion evaluating OPT-302 in combination with aflibercept in participants with persistent central-involved Diabetic Macular Edema.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesAustralia, Israel, Latvia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 2018
Enrollment StartJan 2018
Primary CompletionMar 2020
Study CompletionJun 2020
TodayJul 2026
First PostedJan 11, 2018
Enrollment StartJan 16, 2018
Primary CompletionMar 26, 2020
Study CompletionJun 11, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.5 years ago
Interventions
Afliberceptbiological
Intravitreal injection
OPT-302biological
Intravitreal Injection
Sham intravitreal injectionother
Sham (mock) intravitreal injection