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NCT05203939 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety and Efficacy of OCU400 for Retinitis Pigmentosa and Leber Congenital Amaurosis
A Phase 1 study of Retinitis Pigmentosa and Leber Congenital Amaurosis, sponsored by Ocugen.
- Active
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 7
- Study locations
NCT05203939: Active Phase 1 study of Retinitis Pigmentosa and Leber Congenital Amaurosis, sponsored by Ocugen.
NCT05203939 is a Phase 1 study of Retinitis Pigmentosa and Leber Congenital Amaurosis that is active but no longer recruiting, run by Ocugen. The registered enrollment target is 22 participants, below the 261-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (92% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05203939, a Phase 1 study of Retinitis Pigmentosa and Leber Congenital Amaurosis, is active but no longer recruiting, sponsored by Ocugen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a Phase 1/2 Study to Assess the Safety and Efficacy of OCU400 in patients with retinitis pigmentosa associated with NR2E3 and RHO mutations and in patients with LCA due to mutation(s) in CEP290 gene (OCU400-101). To document prospective eye pathology in the above subjects Investigators will also conduct a Natural History Study (OCU400-104)i This is a multicenter study, which will be conducted in two phases and will enroll up to a total of 24 subjects in the OCU400-101 and 100 subjects in the OCU400-104 study.
Primary Outcome
Counts, frequencies and percentages of SDAEs. SDAE is a primary adverse event of interest and defined as AEs and SAEs that are direct subjects to the Study Drug only.
Conditions Studied
Interventions
- DRUG OCU400 Low Dose
- DRUG OCU400 Med Dose
- DRUG OCU400 High Dose
- DRUG OCU400 Second Eye Dosing
Study Locations (7)
Arizona
- Associated Retina Consultants - Phoenix
California
- Ocugen Site 5 - University of California, San Diego (UCSD) - Shiley Eye Institute - La Jolla
Florida
- Ocugen Site 3 - Bascom Palmer Eye Institute - Miami
Georgia
- Ocugen Site 6 - Emory University - Atlanta
Oregon
- Ocugen Site 2 - Casey Eye Institute - OHSU - Portland
Pennsylvania
- Ocugen Site 8 - Mid Atlantic Retina - Wills Eye Hospital - Philadelphia
Texas
- Ocugen Site 1 - Retina Foundation of the Southwest - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2022-01-24 |
| Est. Completion | 2027-03 |
| Phase | Phase 1 |
What the registry record for NCT05203939 still lists
NCT05203939 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 261-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Retinitis Pigmentosa appearing as the primary indexed condition, and to 4 interventions - of which OCU400 Low Dose is the first listed.
NCT05203939 lists 7 locations in 7 states (Arizona, California, Florida).
Frequently Asked Questions
What is clinical trial NCT05203939 about?
NCT05203939 is a clinical study titled "Study to Assess the Safety and Efficacy of OCU400 for Retinitis Pigmentosa and Leber Congenital Amaurosis". This is a Phase 1/2 Study to Assess the Safety and Efficacy of OCU400 in patients with retinitis pigmentosa associated with NR2E3 and RHO mutations and in patients with LCA due to mutation(s) in CEP290 gene (OCU400-101). To document prospective eye pathology in the above subjects Investigators will ...
What is the current status of trial NCT05203939?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2022-01-24. Estimated completion is 2027-03.
What conditions does trial NCT05203939 study?
This clinical trial studies the following conditions: Retinitis Pigmentosa, Leber Congenital Amaurosis.
What interventions are being tested in trial NCT05203939?
The interventions under investigation include: OCU400 Low Dose (DRUG), OCU400 Med Dose (DRUG), OCU400 High Dose (DRUG), OCU400 Second Eye Dosing (DRUG).
Who is sponsoring clinical trial NCT05203939?
This trial is sponsored by Ocugen, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05203939 being conducted?
This trial has 7 study locations across Arizona, California, Florida, Georgia, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Retinitis Pigmentosa
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05203939's enrollment target sits among peer trials
22 24th of 37 higher than 14 of 37 other Retinitis Pigmentosa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Retinitis Pigmentosa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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