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NCT05616793 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability Subretinal OPGx-001 for LCA5-Associated Inherited Retinal Degeneration (LCA5-IRD) and Non-interventional Arm With Untreated Patients
A Phase 1 study of LCA5, sponsored by Opus Genetics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 2
- Study locations
NCT05616793 is a Phase 1 study of LCA5 that is actively recruiting participants, run by Opus Genetics. The registered enrollment target is 22 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT05616793, a Phase 1 study of LCA5, is actively recruiting participants, sponsored by Opus Genetics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 2
- Study locations
Study 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).
Conditions Studied
Interventions
- BIOLOGICAL AAV8.hLCA5
Study Locations (2)
Pennsylvania
- University of Pennsylvania Perelman School of Medicine - Philadelphia
Texas
- Retina Foundation of the Southwest - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2023-06-15 |
| Est. Completion | 2028-06-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05616793
The ClinicalTrials.gov registry entry for NCT05616793 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Opus Genetics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with LCA5 appearing as the primary indexed condition, and to 1 intervention - of which AAV8.hLCA5 is the first listed.
NCT05616793 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT05616793 about?
NCT05616793 is a clinical study titled "Safety and Tolerability Subretinal OPGx-001 for LCA5-Associated Inherited Retinal Degeneration (LCA5-IRD) and Non-interventional Arm With Untreated Patients". 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 Offic...
What is the current status of trial NCT05616793?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2023-06-15. Estimated completion is 2028-06-15.
What conditions does trial NCT05616793 study?
This clinical trial studies the following conditions: LCA5.
What interventions are being tested in trial NCT05616793?
The interventions under investigation include: AAV8.hLCA5 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05616793?
This trial is sponsored by Opus Genetics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05616793 being conducted?
This trial has 2 study locations across Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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