Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Conditions Studied

Retinitis Pigmentosa Leber Congenital Amaurosis

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

FieldValue
Enrollment Target 22 participants
Start Date 2022-01-24
Est. Completion 2027-03
Phase Phase 1

Sponsor

Ocugen

8 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05203939

The ClinicalTrials.gov registry entry for NCT05203939 describes a study currently listed as active not 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, below the 261-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (92% lower). The listed sponsor is Ocugen, which has 8 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 7 distinct geographic areas - top geographies include 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.

Explore more on PlainTrial

Retinitis Pigmentosa

All registered trials for this condition

Leber Congenital Amaurosis

All registered trials for this condition

Arizona

All trials with a study site in Arizona

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.