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A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa
NCT06388200 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and patients with any other RP associated mutation with a clinical phenotype of RP. This is a multicenter, assessor blinded and randomized study which will enroll 140 subjects. Study has completed enrollment of all 140 subjects.
Conditions Studied
Interventions
- GENETIC Sub-Retinal Administration of OCU400-301
Study Locations (17)
Texas
- Retina Consultants of Texas — Bellaire
- Retina Foundation of the Southwest — Dallas
- Baylor College of Medicine — Houston
- Valley Retina Institute — McAllen
California
- University of Southern Califormia — La Jolla
- University of Southern California, Roski Eye Insitute — Los Angeles
Florida
- Advanced Research, LLC. — Deerfield Beach
- Bascom Palmer Eye Institute, University of Miami, Miller School of Medicine — Miami
Alberta
- Calgary Retina Consultants — Calgary
- University of Alberta — Edmonton
Arizona
- Associated Retina Consultants — Phoenix
Pennsylvania
- Erie Retina Research LLC — Erie
Tennessee
- Vanderbilt Eye Institute — Nashville
Wisconsin
- Gundersen Health System — La Crosse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2024-06-18 |
| Est. Completion | 2027-02-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06388200
The ClinicalTrials.gov registry entry for NCT06388200 describes a study currently listed as active not recruiting. It is categorized as Phase 3, 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 140 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 Retinitis Pigmentosa appearing as the primary indexed condition, and to 1 intervention — of which Sub-Retinal Administration of OCU400-301 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: NCT06388200 reports 17 study locations spanning 11 distinct geographic areas — top geographies include Texas, California, Florida. 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 NCT06388200 about?
NCT06388200 is a clinical study titled "A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa". This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and patients with any other RP associated mutation with a clinical phenotype of RP. This is a multicenter, assessor blinded and randomized study...
What is the current status of trial NCT06388200?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2024-06-18. Estimated completion is 2027-02-12.
What conditions does trial NCT06388200 study?
This clinical trial studies the following conditions: Retinitis Pigmentosa. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06388200?
The interventions under investigation include: Sub-Retinal Administration of OCU400-301 (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06388200?
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 NCT06388200 being conducted?
This trial has 17 study locations across Arizona, California, Florida, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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