Expanded Access Program for RP in Adults

NO_LONGER_AVAILABLE

Conditions studied: Retinitis Pigmentosa

In brief

This intermediate-size patient population expanded access program is to provide access to investigational product OCU400 for up to 75 patients with Retinitis Pigmentosa (RP) outside of the ongoing clinical trial Phase 3 program for patients who do not have access to alternative Food and Drug Administration (FDA)-approved products for treatment of the disease.

Key facts

Study ID

NCT06574997

Run by

Ocugen

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females ≥18 years of age at the time of informed consent.
• Confirmed clinical and CLIA certified genetic diagnosis of RP (except subjects with AD-NR2E3 mutation)
• Presence of photoreceptors as determined by spectral-domain optical coherence tomography (SD-OCT).

You may not qualify if…

• Subject lacks evidence of outer nuclear layer, i.e., containing the nuclei of the retinal photoreceptors as determined by SD- OCT.
• Considered unsuitable for any reason that may either place the subject at increased risk during participation or interfere with the interpretation of the study outcomes by the Investigator, or the Sponsor after reviewing the subject medical history and condition.
• Previous treatment with a gene-therapy or cell therapy product, excluding OCU400.
• Previous treatment with any investigational drug or device within one year, excluding OCU400.
• Any contraindications for subretinal injection.
• Cataract surgery within 3 months. YAG capsulotomy within 1 month. Any other intraocular surgery within 6 months

Where it is running

• Associated Retina Consultants — Phoenix, Arizona, United States
• Advanced Research — Deerfield Beach, Florida, United States
• Erie Retina Research — Erie, Pennsylvania, United States
• Valley Retina Institute — McAllen, Texas, United States
• Gundersen Health — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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