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NCT02863354 · ClinicalTrials.gov registry record · Phase 2
Intravitreal Aflibercept for Retinal Non-Perfusion in Proliferative Diabetic Retinopathy
A Phase 2 study of Proliferative Diabetic Retinopathy, sponsored by Charles C Wykoff, PhD, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 4
- Study locations
NCT02863354: Completed Phase 2 study of Proliferative Diabetic Retinopathy, sponsored by Charles C Wykoff, PhD, MD.
NCT02863354 is a Phase 2 study of Proliferative Diabetic Retinopathy that has completed, run by Charles C Wykoff, PhD, MD. The registered enrollment target is 43 participants, below the 208-participant average among 5 other Proliferative Diabetic Retinopathy trials with a reported enrollment target (79% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02863354, a Phase 2 study of Proliferative Diabetic Retinopathy, has completed, sponsored by Charles C Wykoff, PhD, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 4
- Study locations
Study Summary
The RECOVERY trial will assess the safety and tolerability of 2 mg intravitreal aflibercept injections (IAI) given monthly (Q4WK) or every 12 weeks (Q12WK) for the treatment of retinal capillary non-perfusion (RNP) associated with proliferative diabetic retinopathy (PDR). * Assess the safety and tolerability of IAI for the treatment of proliferative diabetic retinopathy by evaluating the incidence and severity of ocular and systemic adverse events through week 52 * Change in area of retinal capillary non-perfusion, as assessed by central reading center, from baseline through week 52
Primary Outcome
• Assess the safety and tolerability of IAI for the treatment of proliferative diabetic retinopathy by evaluating the incidence and severity of ocular and systemic adverse events through week 52 and week 100.
Conditions Studied
Interventions
- DRUG Aflibercept
Study Locations (4)
Texas
- Retina Consultants of Houston/The Medical Center - Houston
- Retina Consultants of Houston/Katy office - Katy
- Retina Consultants of Houston - Kingwood
- Retina Consultants of Houston - The Woodlands
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2016-08 |
| Est. Completion | 2019-05 |
| Phase | Phase 2 |
What the finished NCT02863354 record still lists
NCT02863354 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 208-participant average among 5 other Proliferative Diabetic Retinopathy trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Proliferative Diabetic Retinopathy appearing as the primary indexed condition, and to 1 intervention - of which Aflibercept is the first listed.
NCT02863354 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02863354 about?
NCT02863354 is a clinical study titled "Intravitreal Aflibercept for Retinal Non-Perfusion in Proliferative Diabetic Retinopathy". The RECOVERY trial will assess the safety and tolerability of 2 mg intravitreal aflibercept injections (IAI) given monthly (Q4WK) or every 12 weeks (Q12WK) for the treatment of retinal capillary non-perfusion (RNP) associated with proliferative diabetic retinopathy (PDR). * Assess the safety and to...
What is the current status of trial NCT02863354?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2016-08. Estimated completion is 2019-05.
What conditions does trial NCT02863354 study?
This clinical trial studies the following conditions: Proliferative Diabetic Retinopathy.
What interventions are being tested in trial NCT02863354?
The interventions under investigation include: Aflibercept (DRUG).
Who is sponsoring clinical trial NCT02863354?
This trial is sponsored by Charles C Wykoff, PhD, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02863354 being conducted?
This trial has 4 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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