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Safety and Efficacy Study of Novel Gene Therapy ZM-01 for X-linked Retinoschisis Patients

NCT06066008 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2026-03-31

No results posted yet for this study

Summary

This trial is meant to evaluate the safety and efficacy of ZM-01 of X-linked retinoschisis. Unilateral intravitreal injections (IVT) will be given into the subject's Study Eye.

Conditions

  • X-linked Retinoschisis

Interventions

DRUG

ZM-01-L

rAAV-hRS1 intravitreal injection of low dose

DRUG

ZM-01-H

rAAV-hRS1 intravitreal injection of high dose

Sponsors & Collaborators

  • Zhongmou Therapeutics

    lead INDUSTRY

Principal Investigators

  • Yin Shen, PhD · Zhongmou Theraputics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-25
Primary Completion
2023-10-31
Completion
2026-01-31

Countries

  • China

Study Locations

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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 NCT06066008 on ClinicalTrials.gov