At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Double-Masked, Randomized Study of the Efficacy and Safety of Intravitreal Aflibercept Injection in Patients With Moderately Severe to Severe Nonproliferative Diabetic Retinopathy
In Brief
A Phase 3 clinical trial evaluating Intravitreal aflibercept injection [IAI] and Sham for Nonproliferative Diabetic Retinopathy. Completed, enrolled 402 participants across 89 sites in 6 countries.
Detailed Summary
The primary objective of the study is to assess the efficacy of intravitreal (IVT) aflibercept compared to sham treatment in the improvement of moderately severe to severe nonproliferative diabetic retinopathy (NPDR). The secondary objectives of the study are: * To characterize the safety of IVT aflibercept in patients with moderately severe to severe NPDR * To determine if IVT aflibercept will prevent the worsening of diabetic retinopathy and reduce the incidence of DME * To determine the anatomic effects of IVT aflibercept in patients with moderately severe to severe NPDR