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Safety and Efficacy Study of Novel Gene Therapy ZM-02 for Retinitis Pigmentosa Patients

NCT06292650 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-31

No results posted yet for this study

Summary

This is zM-02's safety, tOlerability, and efficacy in retinitis pigmentOsa first-in-humaN study (MOON). This trial is meant to evaluate the safety and efficacy of ZM-02 in Retinitis pigmentosa (RP) patients. Unilateral intravitreal injections (IVT) will be given into the subject's Study Eye.

Conditions

Interventions

DRUG

ZM-02-L

rAAV-PsCatCh2.0 intravitreal injection of low dose

DRUG

ZM-02-H

rAAV-PsCatCh2.0 intravitreal injection of high dose

PROCEDURE

ZM-02-S

sham intravitreal injection of ZM-02 (not actual injection)

Sponsors & Collaborators

  • Zhongmou Therapeutics

    lead INDUSTRY

Principal Investigators

  • Wenbin Wei, PhD · Beijing Tongren Hospital, CMU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-25
Primary Completion
2027-12-25
Completion
2028-12-25

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06292650 on ClinicalTrials.gov