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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)

NCT07282457 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-04-13

No results posted yet for this study

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).

Conditions

  • Retinitis Pigmentosa (RP)

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

Sponsors & Collaborators

  • Zhongmou Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
6 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-25
Primary Completion
2029-12-25
Completion
2031-12-25

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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 NCT07282457 on ClinicalTrials.gov