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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site contacts updated at 1 of 2 sitesv8
  2. Primary endpoints: 4 to 15v7 Show 7 more changesShow less
    • Enrollment target: 15 to 22
    • Study sites: 1 to 2
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: 6 to 4
    • Study description expanded, about 27 words
    • Study title expanded, about 6 words
    • Study arms: 3 to 4
  3. Site contact updated
    • Collaborators: 2 to 1
    v6
  4. Primary completion date: Dec 30, 2024 to Jun 15, 2028
    • Study completion date: Jan 30, 2028 to Jun 15, 2028
    • Collaborators: 1 to 2
    v5
  5. Enrollment target: 9 to 15v4 Show 7 more changesShow less
    • Primary endpoints revised (4)
    • Primary completion date: Aug 30, 2024 to Dec 30, 2024
    • Study completion date: Sep 30, 2027 to Jan 30, 2028
    • Eligibility criteria revised
    • Secondary endpoints: 5 to 6
    • Study description revised
    • Collaborators expanded, about 3 words
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 31, 2023 to Jun 15, 2023
    v3
  2. Enrollment target: 6 to 9
    • Study completion date: Sep 30, 2026 to Sep 30, 2027
    • Eligibility criteria shortened, about 20 words
    • Study description shortened, about 6 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05616793
Lead Sponsor Opus Genetics, Inc
Collaborators: University of Pennsylvania
Conditions
(from sponsor)		 LCA5
Related terms Retinal Degeneration
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov