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Active, not recruiting Phase 3 Interventional

A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa

ClinicalTrials.gov ID: NCT06388200

Public ClinicalTrials.gov record NCT06388200. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 16, 2026, 7:47 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Multi-Center, Randomized Study to Assess The Efficacy, Safety and Tolerability of Subretinal OCU400 Gene Therapy for the Treatment of Retinitis Pigmentosa

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06388200
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Ocugen
Industry
Enrollment
140 participants

Conditions and interventions

Eligibility (public fields only)

Age range
3 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 18, 2024 (Actual)
Primary completion
Feb 12, 2027 (Estimated)
Completion
Feb 12, 2027 (Estimated)
Last update posted
Jul 31, 2026

2024 – 2027

United States locations

U.S. sites
12
U.S. states
7
U.S. cities
12
Facility City State ZIP Site status
Associated Retina Consultants Phoenix Arizona 85020 —
University of Southern Califormia La Jolla California 92093 —
University of Southern California, Roski Eye Insitute Los Angeles California 90033 —
Advanced Research, LLC. Deerfield Beach Florida 33064 —
Bascom Palmer Eye Institute, University of Miami, Miller School of Medicine Miami Florida 33136 —
Erie Retina Research LLC Erie Pennsylvania 16507 —
Vanderbilt Eye Institute Nashville Tennessee 37232 —
Retina Consultants of Texas Bellaire Texas 77401 —
Retina Foundation of the Southwest Dallas Texas 75231 —
Baylor College of Medicine Houston Texas 77030 —
Valley Retina Institute McAllen Texas 78503 —
Gundersen Health System La Crosse Wisconsin 54601 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06388200, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 31, 2026 · Synced Oct 16, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06388200 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →