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Prospective, Randomized, Sham-controlled, Dose-finding I/II Trial of Safety and Efficacy of Modified Optogenetic Gene Therapy (ZM-02 Injection)
Sponsor: Zhongmou Therapeutics
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
Conditions
Interventions
ZM-02 (low dose)
Single unilateral IVT injection of low-dose ZM-02 in the study eye
ZM-02 (high dose)
Single unilateral IVT injection of high-dose ZM-02 in the study eye
ZM-02 (selected dose)
Single unilateral IVT injection of selected-dose ZM-02 in the study eye
Sham injection
Sham IVT procedure in the study eye