Trials / Completed
CompletedNCT02718326
Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 402 (actual)
- Sponsor
- Regeneron Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Intravitreal aflibercept injection [IAI] | |
| DRUG | Sham |
Timeline
- Start date
- 2016-03-29
- Primary completion
- 2018-08-06
- Completion
- 2019-07-16
- First posted
- 2016-03-24
- Last updated
- 2020-07-30
- Results posted
- 2019-11-21
Locations
89 sites across 6 countries: United States, Germany, Hungary, Japan, Puerto Rico, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02718326. Inclusion in this directory is not an endorsement.