Actively Recruiting
Safety and Efficacy Study of Novel Gene Therapy ZM-02 for Retinitis Pigmentosa Patients
Led by Zhongmou Therapeutics · Updated on 2026-03-31
12
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy Study of Novel Gene Therapy ZM-02 for Retinitis Pigmentosa Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically diagnosed with retinal pigment degeneration
- Visual acuity of the study eye is no better than finger counting and not better than the other eye
- Subject has had visual experience better than finger counting
- OCT shows disappearance of the ellipsoid zone but preservation of inner nuclear and nerve fiber layers in the tested eye
- Refractive power of the tested eye between -6.00 D and +6.00 D
- Not infected with HIV or other acute or chronic infectious diseases
- Age between 18 and 65 years and voluntarily signed informed consent
- Able to fully understand and agree to cooperate with the research protocol
You will not qualify if you...
- Pregnant or breastfeeding women, or subjects unwilling to use contraception 12 months before and after medication
- Narrow anterior chamber angles or medical conditions contraindicating pupil dilation
- Allergy or intolerance to corticosteroids or active infections contraindicating treatment
- Systemic diseases, mental illnesses, or safety concerns for the study
- Other diseases affecting visual function (e.g., glaucoma, CNS lesions), excluding mild cataracts
- Eye diseases interfering with vision assessment or ocular tests like OCT
- Tumors, metabolic or immune-related diseases affecting trial
- Major eye surgery within 3 months before screening
- History of malignant tumors within 5 years
- Retinal diseases unsuitable for study such as retinal detachment
- Current or potential immunosuppressive treatment for other diseases
- Participation in other clinical trials within last 3 months
- Prior gene therapy outside this study
- Other reasons deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
W
Windy Zhou
CONTACT
Y
Yin Shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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