Gene therapy for patients with retinitis pigmentosa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of a novel gene therapy, ZM-02, in patients diagnosed with retinitis pigmentosa (RP). The study involves administering unilateral intravitreal injections of ZM-02 to participants, with a control group receiving sham injections. The trial aims to assess the treatment's tolerability and effectiveness in improving vision in individuals with this inherited retinal disease. A total of 8 to 12 subjects will be recruited, with varying doses of the gene therapy being tested.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients who meet all of the following criteria can be selected as subjects:

1. Clinically diagnosed with retinal pigment degeneration
2. 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
3. The subject has had visual experience above the finger counting
4. 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
5. The refractive power of the tested eye is between -6.00 D and +6.00 D
6. Not infected with the Human Immunodeficiency Virus (HIV) and other acute and chronic infectious diseases
7. Voluntarily sign an Informed Consent Form (ICF), and the age is not less than 18 years and not more than 65 years
8. Able to fully understand and agree to cooperate with the implementation of the research protocol

Exclusion Criteria:

Subjects who meet any one of the following exclusion criteria will be excluded from the study:

1. Pregnant women, breastfeeding women, or male and female subjects who do not agree to contraception during the 12 months before and after medication
2. Subjects with narrow anterior chamber angles or any other medical conditions that contraindicate pupil dilation
3. 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
4. Subjects with systemic diseases, or other medical or mental illnesses, or other safety concerns for the study
5. 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)
6. Eye diseases that may interfere with the assessment of vision during the study and/or interfere with other ocular assessments such as OCT
7. Diseases that may affect the clinical trial, such as tumors, metabolic, immune-related diseases, etc.
8. Subjects who have undergone major eye surgery within the last 3 months before screening
9. Subjects with a history of malignant tumors within the last 5 years
10. Subjects with other retinal diseases not suitable for this study, such as retinal detachment
11. Patients undergoing or potentially undergoing immunosuppressive treatment for other diseases, excluding this study
12. Participation in any clinical trials other than this study within the last 3 months
13. Subjects who have received gene therapy outside of this study
14. Other reasons deemed by the researcher as unsuitable for participation in this study

Where it's running

• Beijing Tongren Hospital of Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Wenbin Wei, PhD — Beijing Tongren Hospital, CMU
• Study coordinator: Windy Zhou
• Email: zmt@zmtherapeutics.com
• Phone: +86 18986214263

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• ZVS203e eye gene-editing therapy for a specific RHO-related retinitis pigmentosa

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• Safety of a one-time DSP-3077 retinal sheet injection in adults with retinitis pigmentosa

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.