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

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Retinitis Pigmentosa

In brief

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.

Key facts

Study ID

NCT06292650

Run by

Zhongmou Therapeutics

People needed

12

Starts

2024-02-25

Expected to finish

2028-12-25

Last updated by the study team

2026-03-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who meet all of the following criteria can be selected as subjects:
• Clinically diagnosed with retinal pigment degeneration
• The visual acuity of study eye is no better than the finger counting, while the visual acuity of the study eye is not better than that of the contralateral eye
• The subject has had visual experience above the finger counting
• In the OCT examination of the tested eye, the disappearance of the ellipsoid zone is observed, but the inner nuclear layer and the nerve fiber layer of the retina are still present
• The refractive power of the tested eye is between -6.00 D and +6.00 D
• Not infected with the Human Immunodeficiency Virus (HIV) and other acute and chronic infectious diseases
• Voluntarily sign an Informed Consent Form (ICF), and the age is not less than 18 years and not more than 65 years
• Able to fully understand and agree to cooperate with the implementation of the research protocol

You may not qualify if…

• Subjects who meet any one of the following exclusion criteria will be excluded from the study:
• Pregnant women, breastfeeding women, or male and female subjects who do not agree to contraception during the 12 months before and after medication
• Subjects with narrow anterior chamber angles or any other medical conditions that contraindicate pupil dilation
• Subjects allergic to corticosteroids, who are unable to tolerate the corticosteroid treatment described in the protocol, or have active 4. concurrent infections that contraindicate treatment
• Subjects with systemic diseases, or other medical or mental illnesses, or other safety concerns for the study
• Subjects with other symptoms and/or diseases or conditions that can alter visual function, including but not limited to glaucoma and central nervous system lesions (mild cataracts are not included in this restriction)
• Eye diseases that may interfere with the assessment of vision during the study and/or interfere with other ocular assessments such as OCT
• Diseases that may affect the clinical trial, such as tumors, metabolic, immune-related diseases, etc.
• Subjects who have undergone major eye surgery within the last 3 months before screening
• Subjects with a history of malignant tumors within the last 5 years
• Subjects with other retinal diseases not suitable for this study, such as retinal detachment
• Patients undergoing or potentially undergoing immunosuppressive treatment for other diseases, excluding this study
• Participation in any clinical trials other than this study within the last 3 months
• Subjects who have received gene therapy outside of this study
• Other reasons deemed by the researcher as unsuitable for participation in this study

Where it is running

• Beijing Tongren Hospital of Capital Medical University — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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