NCT06574997

Expanded Access Program for RP in Adults

An Expanded Access Program for Retinitis Pigmentosa in Adults Aged 18 Years and Older

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Ocugen · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: —

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 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.

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, review of concomitant medication, blood work and ocular examinations for up to 52 weeks (about 12 months) post dosing.

Conditions

• Retinitis Pigmentosa

Interventions

Type	Name	Description
DRUG	OCU400	Participants will receive a subretinal injection of OCU400 modifier gene therapy product.

Timeline

• First posted: 2024-08-28
• Last updated: 2026-04-13

Locations

4 sites across 1 country: United States