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A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa

NCT06388200 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-03-05

No results posted yet for this study

Summary

This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and patients with any other RP associated mutation with a clinical phenotype of RP.

This is a multicenter, assessor blinded and randomized study which will enroll 140 subjects. Study has completed enrollment of all 140 subjects.

Conditions

Interventions

GENETIC

Sub-Retinal Administration of OCU400-301

Sub-Retinal Administration of OCU400-301

Sponsors & Collaborators

Principal Investigators

  • Huma Qamar · Ocugen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-18
Primary Completion
2027-02-12
Completion
2027-02-12
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06388200 on ClinicalTrials.gov