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NCT05956626 · ClinicalTrials.gov registry record · Phase 2
A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease
A Phase 2 study of Stargardt Disease, sponsored by Ocugen.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 14
- Study locations
NCT05956626: Recruiting Phase 2 study of Stargardt Disease, sponsored by Ocugen.
NCT05956626 is a Phase 2 study of Stargardt Disease that is actively recruiting participants, run by Ocugen. The registered enrollment target is 51 participants, below the 88-participant average among 16 other Stargardt Disease trials with a reported enrollment target (42% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05956626, a Phase 2 study of Stargardt Disease, is actively recruiting participants, sponsored by Ocugen.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 14
- Study locations
Study Summary
Phase 2/3 Pivotal Confirmatory Clinical Trial is a randomized, outcome assessor-masked, multicenter study, that will enroll fifty-one (51) subjects. Subjects will be enrolled in a 2:1 ratio to either the treatment group (n=34 subjects) or to an untreated control group (n=17 subjects). Phase 1 is complete and closed for enrollment. It was a multicenter, open-label, dose ranging/dose escalation study that enrolled 9 subjects.
Primary Outcome
Change in the area of atrophy will be evaluated from the baseline measurements, using FAF to assess the loss of retinal layers.
Conditions Studied
Interventions
- DRUG OCU410ST
Study Locations (14)
Florida
- Vitreo Retinal Associates, P.A. - Gainesville
- Bascom Palmer Eye Institute - Miami
- Advanced Research, LLC - Pompano Beach
Texas
- Retina Consultants of Texas - Bellaire
- Retina Foundation of the Southwest - Dallas
- Valley Retina Institute - McAllen
Arizona
- Associated Retina Consultants - Phoenix
California
- Retinal Consultants Medical Group - Sacramento
Indiana
- Retina Partners Midwest, P.C. - Carmel
Massachusetts
- Boston Children's Hospital - Boston
Mississippi
- Mississippi Retina Associates - Jackson
Missouri
- The Retina Institute - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2023-08-25 |
| Est. Completion | 2026-09-28 |
| Phase | Phase 2 |
What NCT05956626 shows while recruiting
NCT05956626 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 88-participant average among 16 other Stargardt Disease trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Stargardt Disease appearing as the primary indexed condition, and to 1 intervention - of which OCU410ST is the first listed.
NCT05956626 lists 14 locations in 10 states (Florida, Texas, Arizona).
Frequently Asked Questions
What is clinical trial NCT05956626 about?
NCT05956626 is a clinical study titled "A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease". Phase 2/3 Pivotal Confirmatory Clinical Trial is a randomized, outcome assessor-masked, multicenter study, that will enroll fifty-one (51) subjects. Subjects will be enrolled in a 2:1 ratio to either the treatment group (n=34 subjects) or to an untreated control group (n=17 subjects). Phase 1 is co...
What is the current status of trial NCT05956626?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2023-08-25. Estimated completion is 2026-09-28.
What conditions does trial NCT05956626 study?
This clinical trial studies the following conditions: Stargardt Disease.
What interventions are being tested in trial NCT05956626?
The interventions under investigation include: OCU410ST (DRUG).
Who is sponsoring clinical trial NCT05956626?
This trial is sponsored by Ocugen, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05956626 being conducted?
This trial has 14 study locations across Arizona, California, Florida, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05956626's enrollment target sits among peer trials
51 10th of 16 higher than 7 of 16 other Stargardt Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stargardt Disease 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.
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