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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 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 402 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02718326
The ClinicalTrials.gov registry entry for NCT02718326 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 402 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.
NCT02718326 reports 0 study locations.
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.
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