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ACTIVE NOT RECRUITING
NCT06388200
PHASE3

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

Sponsor: Ocugen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

3 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2024-06-18

Completion Date

2027-02-12

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

GENETIC

Sub-Retinal Administration of OCU400-301

Sub-Retinal Administration of OCU400-301

Locations (17)

Associated Retina Consultants

Phoenix, Arizona, United States

University of Southern Califormia

La Jolla, California, United States

University of Southern California, Roski Eye Insitute

Los Angeles, California, United States

Advanced Research, LLC.

Deerfield Beach, Florida, United States

Bascom Palmer Eye Institute, University of Miami, Miller School of Medicine

Miami, Florida, United States

Erie Retina Research LLC

Erie, Pennsylvania, United States

Vanderbilt Eye Institute

Nashville, Tennessee, United States

Retina Consultants of Texas

Bellaire, Texas, United States

Retina Foundation of the Southwest

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Valley Retina Institute

McAllen, Texas, United States

Gundersen Health System

La Crosse, Wisconsin, United States

Calgary Retina Consultants

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

The University of British Columbia

Vancouver, British Columbia, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada