Clinical Trial

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

Recruiting Phase 1/2
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Summary
The goals of this clinical trial are assess the natural course of LCA5-IRD over 6 months and to evaluate the safety and preliminary efficacy of subretinal gene therapy with OPGx-001 in patients with inherited retinal degeneration due to biallelic mutations in the LCA5 gene. Funding Source- FDA Office of Orphan Products Development (OOPD).
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2022-11-07; most recent amendment 2026-02-18.
Status change: Not Yet Recruiting → Recruiting 2023-06-15
Trial Details
NCT Number NCT05616793
Lead Sponsor Opus Genetics, Inc
Collaborators: University of Pennsylvania
Conditions LCA5
Enrollment 22 participants
Start Date 2023-06-15
Primary Completion 2028-06-15 (estimated)
Study Completion 2028-06-15 (estimated)
Updated on ClinicalTrials.gov 2026-02-19