Safety and Tolerability Subretinal OPGx-001 for LCA5-Associated Inherited Retinal Degeneration (LCA5-IRD) and Non-interventional Arm With Untreated Patients

Exclusion Criteria

• •1. Women who are pregnant or individuals (women of childbearing potential and men) unwilling to use effective contraception for the duration of the study, including barrier methods for the first year after investigational product (IP) administration (Part A only).
• •2. Pre-existing eye conditions or complicating systemic diseases that would preclude the planned surgery. This includes individuals who are immunocompromised.
• •3. History of intraocular surgery for either eye within 6 months prior to planned IP administration (Part A only).
• •4. Have previously received gene therapy.
• •5. Have used any investigational drug or device within 90 days or 5 estimated half-lives of treatment, whichever is longer or plan to participate in another study of drug or device during the study period.
• •6. History of disease which may preclude the participant from participation, or which may interfere with outcome measure testing or test results.
• •7. Incapable of performing visual function testing (e.g., FST testing) for reasons other than poor vision.
• •8. Any absolute contraindication to a course of oral steroids.
• •9. Any other condition that would not allow the potential participant to complete follow-up examinations during the study and, in the opinion of the Investigator, makes the potential participant unsuitable for the study.