CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 660 enrolled
Drug / intervention
aflibercept +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.

Search/NCT04429503
NCT04429503Phase 3Completed
CompareCT.gov

A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema

Regeneron Pharmaceuticals·interventional·Posted Jun 12, 2020·Updated Aug 8, 2025

In Brief

A Phase 3 clinical trial evaluating aflibercept and High-dose aflibercept for Diabetic Macular Edema and 2 related conditions. Completed, enrolled 660 participants across 138 sites in 8 countries.

Detailed Summary

The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks. The secondary objectives of the study are as follows: * To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response * To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
CountriesCanada, Czechia, Germany, Hungary, Japan, Puerto Rico, United Kingdom, United States
CollaboratorsBayer

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJun 12, 2020
Enrollment StartJun 29, 2020
Primary CompletionMay 30, 2022
Study CompletionJun 18, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.1 years ago

Interventions

afliberceptdrug

Intravitreally (IVT) administered as a liquid formulation in a vial

High-dose afliberceptdrug

Intravitreally (IVT) administered as a liquid formulation in a vial