Expanded Access Program for RP in Adults

Status:

AVAILABLE

Expanded Access Program for RP in Adults

Lead Sponsor:

Ocugen

Conditions:

Retinitis Pigmentosa

Eligibility:

All Genders

18-99 years

Brief Summary

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 cli...

Detailed Description

This expanded access protocol provides access to OCU400 for a subset of patients. Subjects will undergo specific ocular testing included in the study. Subjects will follow-up with physical examination...

Eligibility Criteria

Inclusion

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).

Exclusion

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

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT06574997

Last Update

July 28 2025

Active Locations (4)

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Page 1 of 1 (4 locations)

Associated Retina Consultants

Phoenix, Arizona, United States, 85020

Advanced Research

Deerfield Beach, Florida, United States, 33064

Erie Retina Research

Erie, Pennsylvania, United States, 16507