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NCT02718326 · ClinicalTrials.gov registry record · Phase 3
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 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 402
- Enrollment target
NCT02718326: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT02718326 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 402 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02718326, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 402 participants
- Enrollment target
Study 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
Primary Outcome
The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 24 from baseline.
Interventions
- DRUG Sham
- DRUG Intravitreal aflibercept injection [IAI]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 402 participants |
| Start Date | 2016-03-29 |
| Est. Completion | 2019-07-16 |
| Phase | Phase 3 |
What the finished NCT02718326 record still lists
NCT02718326 is an interventional study that assigns participants to a tested intervention. The registered 402 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.
NCT02718326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02718326 about?
NCT02718326 is a clinical study titled "Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)". 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 a...
What is the current status of trial NCT02718326?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 402 participants. The study started on 2016-03-29. Estimated completion is 2019-07-16.
What interventions are being tested in trial NCT02718326?
The interventions under investigation include: Sham (DRUG), Intravitreal aflibercept injection [IAI] (DRUG).
Who is sponsoring clinical trial NCT02718326?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02718326's enrollment target sits among peer trials
402 919th of 2000 higher than 1,080 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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