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NCT05393284 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy
A Phase 2 study of Proliferative Diabetic Retinopathy and Non-Proliferative Diabetic Retinopathy, sponsored by Valo Health.
- Active
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
- 20
- Study locations
NCT05393284: Active Phase 2 study of Proliferative Diabetic Retinopathy and Non-Proliferative Diabetic Retinopathy, sponsored by Valo Health.
NCT05393284 is a Phase 2 study of Proliferative Diabetic Retinopathy and Non-Proliferative Diabetic Retinopathy that is active but no longer recruiting, run by Valo Health. The registered enrollment target is 114 participants, below the 194-participant average among 5 other Proliferative Diabetic Retinopathy trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05393284, a Phase 2 study of Proliferative Diabetic Retinopathy and Non-Proliferative Diabetic Retinopathy, is active but no longer recruiting, sponsored by Valo Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
- 20
- Study locations
Study Summary
OPL-0401-201 is a multicenter study to investigate the safety and efficacy of OPL-0401 in patients with diabetes mellitus (DM) with diabetic retinopathy.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG OPL-0401 Dose 1
Study Locations (20)
Texas
- Austin Retina Associates - Austin
- Austin Clinical Research, LLC - Austin
- Texas Retina Associates - Dallas
- Valley Retina Institute, PA - McAllen
- Austin Retina Associates - Round Rock - Round Rock
- Medical Center Ophthalmology Associates - San Antonio
California
- Northern California Retina Vitreous Associates - Mountain View
- Retina Consultants of Southern California - Riverside
- Southern California Permanente Medical Group - Riverside
- Retinal Consultants Medical Group - Sacramento
- California Retina Consultants - Santa Barbara
Colorado
- Panorama Eye Care, LLC - Fort Collins
Florida
- Mid Florida Eye Center - Mt. Dora
Louisiana
- Eye Associates of Northeast Louisiana - West Monroe
Maryland
- The Retina Care Center - Baltimore
Massachusetts
- Massachussetts Eye and Ear - Boston
Michigan
- Retina Associates of Michigan - Grand Blanc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2022-08-16 |
| Est. Completion | 2024-08 |
| Phase | Phase 2 |
What the registry record for NCT05393284 still lists
NCT05393284 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 194-participant average among 5 other Proliferative Diabetic Retinopathy trials with a reported enrollment target (41% lower).
The record links to 2 conditions, with Proliferative Diabetic Retinopathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05393284 names 20 study sites across 11 states, led by Texas, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT05393284 about?
NCT05393284 is a clinical study titled "Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy". OPL-0401-201 is a multicenter study to investigate the safety and efficacy of OPL-0401 in patients with diabetes mellitus (DM) with diabetic retinopathy.
What is the current status of trial NCT05393284?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2022-08-16. Estimated completion is 2024-08.
What conditions does trial NCT05393284 study?
This clinical trial studies the following conditions: Proliferative Diabetic Retinopathy, Non-Proliferative Diabetic Retinopathy.
What interventions are being tested in trial NCT05393284?
The interventions under investigation include: Placebo (DRUG), OPL-0401 Dose 1 (DRUG).
Who is sponsoring clinical trial NCT05393284?
This trial is sponsored by Valo Health, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05393284 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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