Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCU400 | Drug | Participants will receive a subretinal injection of OCU400 modifier gene therapy product. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Huma Qamar, MD, MPH, CMI | Ocugen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants | Phoenix | Arizona | 85020 | United States | ||
| Advanced Research |
Not provided
| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
Not provided
Not provided
| Deerfield Beach |
| Florida |
| 33064 |
| United States |
| Erie Retina Research | Erie | Pennsylvania | 16507 | United States |
| Gundersen Health | La Crosse | Wisconsin | 54601 | United States |
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |