🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT06388200
Active, not recruiting Phase 3

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

NCT06388200 · tracked via the Priya Life Science USA tracker
Sponsor
Ocugen
Phase
Phase 3
Started
2024-06-18
Last updated
2026-07-31

Condition(s) studied

Retinitis Pigmentosa

Investigational drug(s) / intervention(s)

Sub-Retinal Administration of OCU400-301

Sub-Retinal Administration of OCU400-301: Sub-Retinal Administration of OCU400-301

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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Males or females ≥ 3 years of age 2. Confirmed genetic diagnosis of autosomal dominant RHO mutation with clinical diagnosis of RP 3. Clinical Diagnosis of Syndromic or Non-Syndromic RP with/without confirmed genetic diagnosis of any other RP associated mutation (except AD-NR2E3) 4. BCVA ≤ 80 letters and ≥25 letters as measured by an ETDRS chart 5. Visual field of \>5° in any meridian as measured by a III4e isopter or equivalent 6. Able to perform a Luminance LDNA at certain light intensity at the Screening visit 7. Presence of photoreceptors as determined by SD-OCT Exclusion Criteria: 1. Subject lacks evidence of outer nuclear layer 2. Previous treatment with a gene-therapy or cell therapy product or treatment with any investigational drug or ocular device within one year. 3. History of any corticosteroid contraindication, corticosteroid related IOP spikes or uncontrolled glaucoma. 4. Cataract surgery within 3 months. YAG capsulotomy within 1 month. Any other intraocular surgery within 6 months. 5. Active ocular/intraocular infection, any history of rhegmatogenous retinal detachment or Current retinal detachment or retinal implant. 6. Breast-feeding, pregnancy, sperm donation or inability to practice strict contraception

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
Associated Retina Consultants Phoenix Arizona
University of Southern Califormia La Jolla California
University of Southern California, Roski Eye Insitute Los Angeles California
Advanced Research, LLC. Deerfield Beach Florida
Bascom Palmer Eye Institute, University of Miami, Miller School of Medicine Miami Florida
Erie Retina Research LLC Erie Pennsylvania
Vanderbilt Eye Institute Nashville Tennessee
Retina Consultants of Texas Bellaire Texas
Retina Foundation of the Southwest Dallas Texas
Baylor College of Medicine Houston Texas
Valley Retina Institute McAllen Texas
Gundersen Health System La Crosse Wisconsin
Calgary Retina Consultants Calgary Alberta
University of Alberta Edmonton Alberta
The University of British Columbia Vancouver British Columbia
Sunnybrook Health Sciences Centre Toronto Ontario
Research Institute of the McGill University Health Centre Montreal Quebec

More Ocugen trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06388200 on ClinicalTrials.gov ↗ ← All trials in the USA