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NOT YET RECRUITING
NCT07282457
PHASE1/PHASE2

Prospective, Randomized, Sham-controlled, Dose-finding I/II Trial of Safety and Efficacy of Modified Optogenetic Gene Therapy (ZM-02 Injection)

Sponsor: Zhongmou Therapeutics

View on ClinicalTrials.gov

Summary

This is a Phase 1/2, multi-center, randomized, sham-controlled, dose-escalation study evaluating ZM-02 in patients with advanced retinitis pigmentosa (RP).

Official title: A Prospective, Randomized, Sham-controlled, Dose-finding Phase 1/2 Two-part Trial to Evaluate the Safety, Tolerability, and Efficacy of ZM-02 Injection in Patients With Advanced Retinitis Pigmentosa

Key Details

Gender

All

Age Range

6 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2026-02-25

Completion Date

2031-12-25

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

GENETIC

ZM-02 (low dose)

Single unilateral IVT injection of low-dose ZM-02 in the study eye

GENETIC

ZM-02 (high dose)

Single unilateral IVT injection of high-dose ZM-02 in the study eye

GENETIC

ZM-02 (selected dose)

Single unilateral IVT injection of selected-dose ZM-02 in the study eye

PROCEDURE

Sham injection

Sham IVT procedure in the study eye