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OCU400

Study Overview

The Phase 1/2 clinical study to evaluate the safety and efficacy of OCU400 for Retinitis Pigmentosa associated with NR2E3 and RHO mutations, utilizing unilateral sub-retinal injection (one eye per study subject) in up to 18 patients, with an extension for contralateral eye and long-term safety follow up.

CURRENTLY RECRUITING

Yes

FOR MORE INFORMATION

www.clinicaltrials.gov

QUESTIONS?

Contact us at
clinical.request@ocugen.com

Study title

A Phase 1/2 Study to Assess the Safety and Efficacy of OCU400 for Retinitis Pigmentosa associated with NR2E3 and RHO mutations

Medical Condition(s)

Retinal degeneration resulting from genetic mutations NR2E3, RHO

Product

AAV-NR2E3
Received orphan drug designation

OCUGEN PROTOCOL NUMBER

OCU400-101

NUMBER OF SUBJECTS

Up to 18 adults who meet eligibility criteria

STUDY LENGTH

12 months

SEX

Male & Female

STUDY DATES

January 2022 – April 2023

AGE

18+

PHASE

1/2

COUNTRY

United States