Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 258-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (46% lower). The listed sponsor is Ocugen, which has 8 total studies on file at ClinicalTrials.gov.
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 reports 17 study locations spanning 11 distinct geographic areas - top geographies include 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.
-
Oral N-acetylcysteine for Retinitis Pigmentosa
ACTIVE NOT RECRUITING · Phase 3
-
Promising ROd-cone DYstrophy Gene therapY
RECRUITING · Phase 1
-
High Resolution Retinal Imaging
RECRUITING
-
Safety of a Single, Intravitreal Injection of 6.0M jCell (Famzeretcel) in Retinitis Pigmentosa (RP)
RECRUITING · Phase 2
-
Observational Study to Assess Endpoint Operational Feasibility & Measurement Properties in Patients with Retinal Degeneration
RECRUITING
-
Retinal Imaging in Patients With Inherited Retinal Degenerations
RECRUITING
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.