CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,011 enrolled
Drug / intervention
Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) +1 moredrug
Likely dose
Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321) 2 mgfrom 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/NCT04423718
NCT04423718Phase 3Completed
CompareCT.gov

Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration

Bayer·interventional·Posted Jun 9, 2020·Updated Aug 29, 2025

In Brief

A Phase 3 clinical trial evaluating Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) and Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321) for Neovascular Age-Related Macular Degeneration. Completed, enrolled 1,011 participants across 235 sites in 27 countries.

Detailed Summary

In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeovascular Age-Related Macular Degeneration
CountriesArgentina, Australia, Austria, Bulgaria, Canada, China, Czechia, Estonia, France, Georgia, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Portugal, Russia, Serbia, Singapore, Slovakia, South Korea, Spain, Switzerland, Taiwan, Ukraine, United States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJun 9, 2020
Enrollment StartAug 11, 2020
Primary CompletionJul 27, 2022
Study CompletionAug 7, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.1 years ago

Interventions

Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)drug

Solution in Vial, intravitreal (IVT) injection

Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)drug

Solution in Vial, 2 mg, intravitreal (IVT) injection