Safety and Tolerability of Subretinal OPGx-001 for LCA5-Associated Inherited Retinal Degeneration (LCA5-IRD)

Brief description of study

To evaluate the safety and tolerability of OPGx-001 administered via subretinal injection to one eye (treated eye) of participants with LCA5-IRD. The safety and tolerability as assessed by: 1. Number of dose limiting toxicity (DLT) events at the proposed doses 2. Number of procedure-related adverse events (AEs) 3. Number and severity of AEs related to OPGx-001 4. Change from baseline in total retinal thickness as assessed by optical coherence tomography (OCT) (changes in total retinal thickness, outer retinal thickness, in microns) To assess the efficacy of a single subretinal injection of OPGx-001 (at three different doses) in the treated eye over 3 years in participants with LCA5-IRD.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
Medical Research
Age: - 99 Years
Gender: All

TBD

Updated on 09 Mar 2024. Study ID: 852708

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