CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Aflibercept Injectiondrug
Likely dose
Aflibercept Injection 2mgfrom 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/NCT03531294
NCT03531294Phase 2Completed
CompareCT.gov

Intravitreal Aflibercept as Indicated by Real-Time Objective Imaging to Achieve Diabetic Retinopathy Improvement

Greater Houston Retina Research·interventional·Posted May 21, 2018·Updated May 21, 2021

In Brief

A Phase 2 clinical trial evaluating Aflibercept Injection for Diabetic Retinopathy. Completed, enrolled 40 participants across 2 sites.

Detailed Summary

The PRIME trial will assess the safety of 2 mg intravitreal aflibercept injections (IAI) to achieve and maintain DRSS improvements (2 or more steps) in patients with a baseline DRSS level of 47A to 71A inclusive through 104 weeks as determined by reading center determined DRSS gradings on OPTOS fundus photos and leakage index on OPTOS WF-FA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Retinopathy
CountriesUnited States
CollaboratorsRegeneron Pharmaceuticals, The Cleveland Clinic

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 21, 2018
Enrollment StartMay 23, 2018
Primary CompletionApr 9, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.1 years ago

Interventions

Aflibercept Injectiondrug

intravitreal 2mg aflibercept injection