CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 106 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/NCT04126317
NCT04126317Phase 2Completed
CompareCT.gov

A Randomized, Single-Masked, Active-Controlled Phase 2 Study of the Safety, Tolerability, and Efficacy of Repeated Doses of High-Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration

Regeneron Pharmaceuticals·interventional·Posted Oct 15, 2019·Updated Aug 14, 2023

In Brief

A Phase 2 clinical trial evaluating aflibercept and High-dose aflibercept for Neovascular (Wet) Age-Related Macular Degeneration. Completed, enrolled 106 participants across 46 sites in 2 countries.

Detailed Summary

The primary objectives of the study are to determine the safety of high-dose aflibercept (hereafter referred to as HD) and to determine if HD provides greater intraocular pharmacodynamic (PD) effect and/or longer duration of action compared to intravitreal aflibercept injection (hereafter referred to as IAI).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeovascular (Wet) Age-Related Macular Degeneration
CountriesPuerto Rico, United States
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 15, 2019
Enrollment StartNov 4, 2019
Primary CompletionMay 14, 2021
Study CompletionNov 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.7 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