RecruitingEarly Phase 1NCT06292650

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

Prospective, Dose-Escalating, Investigator Initiated Trial to Evaluate the Safety and Efficacy of ZM-02 in Retinitis Pigmentosa


Sponsor

Zhongmou Therapeutics

Enrollment

12 participants

Start Date

Feb 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new gene therapy called ZM-02 for people with retinitis pigmentosa (RP) — a genetic eye disease where the light-sensing cells in the retina slowly break down over time, leading to progressive vision loss and potentially blindness. **You may be eligible if...** - You have been clinically diagnosed with retinitis pigmentosa - Your vision in the study eye is very poor (no better than being able to count fingers) but not total darkness — you must have had better vision in the past - An OCT eye scan shows specific retinal findings: the outer photoreceptor layer (ellipsoid zone) has disappeared, but inner retinal layers are still present - Your eye prescription is between -6.00 and +6.00 diopters - You do not have HIV or other active infectious diseases **You may NOT be eligible if...** - You have no remaining functional inner retinal layers - You have total blindness with no prior visual experience - You have HIV or another serious active infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZM-02-L

rAAV-PsCatCh2.0 intravitreal injection of low dose

DRUGZM-02-H

rAAV-PsCatCh2.0 intravitreal injection of high dose

PROCEDUREZM-02-S

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


Locations(1)

Beijing Tongren Hospital of Capital Medical University

Beijing, Beijing Municipality, China

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NCT06292650


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