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A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease
NCT05956626 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05956626
The ClinicalTrials.gov registry entry for NCT05956626 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ocugen, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05956626 reports 14 study locations spanning 10 distinct geographic areas — top geographies include Florida, Texas, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05956626?
The interventions under investigation include: OCU410ST (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05956626?
This trial is sponsored by Ocugen, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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