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NCT06388200 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa
A Phase 3 study of Retinitis Pigmentosa, sponsored by Ocugen.
- Active
- Registry status
- Phase 3
- Development phase
- 140
- Enrollment target
- 17
- Study locations
NCT06388200: Active Phase 3 study of Retinitis Pigmentosa, sponsored by Ocugen.
NCT06388200 is a Phase 3 study of Retinitis Pigmentosa that is active but no longer recruiting, run by Ocugen. The registered enrollment target is 140 participants, below the 258-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (46% lower). The trial reports 17 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06388200, a Phase 3 study of Retinitis Pigmentosa, is active but no longer recruiting, sponsored by Ocugen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 140 participants
- Enrollment target
- 17
- Study locations
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.
Primary Outcome
Change in functional vision from baseline to week 52 in pooled analysis from retinitis pigmentosa subjects when study eyes in treatment group were compared to study eyes in untreated control, as measured by the ability of a study participant to navigate through a maze in Luminance Dependent Navigation Assessment (LDNA)
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 |
What the registry record for NCT06388200 still lists
NCT06388200 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 258-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (46% lower).
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.
NCT06388200 lists 17 locations in 11 states (Texas, California, Florida).
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.
What interventions are being tested in trial NCT06388200?
The interventions under investigation include: Sub-Retinal Administration of OCU400-301 (GENETIC).
Who is sponsoring clinical trial NCT06388200?
This trial is sponsored by Ocugen, which has 8 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Retinitis Pigmentosa
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06388200's enrollment target sits among peer trials
140 9th of 37 higher than 29 of 37 other Retinitis Pigmentosa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Retinitis Pigmentosa 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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