At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 360 enrolled
Drug / intervention
Brolucizumab +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 Two-Year, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Diabetic Macular Edema
In Brief
A Phase 3 clinical trial evaluating Brolucizumab and Aflibercept for Diabetic Macular Edema. Completed, enrolled 360 participants across 78 sites in 23 countries.
Detailed Summary
This was a Phase III, randomized, double-masked, multi-center, active-controlled, two-arm study designed to evaluate the efficacy and safety of brolucizumab 6 mg compared to the active control, aflibercept 2 mg used per authorized label, in subjects with visual impairment due to diabetic macular edema (DME).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesBelgium, Bulgaria, Czechia, Denmark, Estonia, France, Germany, Hungary, India, Latvia, Lebanon, Lithuania, Malaysia, Norway, Poland, Russia, Singapore, Slovakia, South Korea, Sweden, Switzerland, Taiwan, Turkey (Türkiye)
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMar 2018
Enrollment StartJul 2018
Primary CompletionJun 2020
Study CompletionJun 2021
TodayJul 2026
First PostedMar 29, 2018
Enrollment StartJul 27, 2018
Primary CompletionJun 29, 2020
Study CompletionJun 8, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.3 years ago
Interventions
Brolucizumabdrug
Intravitreal injection
Afliberceptdrug
Intravitreal injection