Safety and Efficacy of ZVS203e in the Treatment of Retinitis Pigmentosa Caused by RHO Gene Mutation

Launched by CHIGENOVO CO., LTD · Apr 28, 2025

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ClinConnect Summary

This clinical trial is studying a new treatment called ZVS203e for people with retinitis pigmentosa (RP), a condition that affects the retina and can lead to vision loss. Specifically, the trial is looking at patients with a specific mutation in the RHO gene. The goal is to find out how safe the treatment is, how well it works, and whether it can be tolerated by patients when injected into the eye. The trial will include two stages: first, a smaller group will test different doses to ensure safety, and then a larger group will receive the most effective dose.

To be eligible for this trial, participants must be 18 years or older and have been diagnosed with RP due to the specific RHO gene mutation. They should also have a certain level of vision that can be measured. Participants need to agree to use effective contraception during the trial and for a year afterward. They should be willing to sign consent forms and follow the study's requirements. It's important to note that individuals with certain eye conditions or those who have had specific eye surgeries recently may not qualify. Overall, participants can expect close monitoring and support throughout the trial process.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with a clinical diagnosis of retinitis pigmentosa (RP) (aged 18 years or older);
• • 2. RHO (c.403C\>T, p.R135W) gene site-specific mutation was confirmed by genetic testing, and no other ophthalmic genetic diseases were complicated;
• • 3. The researchers judged that the target eye had viable retinal photoreceptor cells and retinal pigment epithelial cells;
• • 4. The best corrected visual acuity of the target eye is between 2.0 LogMAR and 0.5 LogMAR (including 2.0 LogMAR and 0.5 LogMAR, which is equivalent to a number of fingers to 60 letters);
• • 5. The subject and his or her spouse agree to use effective contraception during the trial period and for at least 1 year after dosing;
• • 6. Voluntarily participate in clinical trials and sign informed consent, and can complete the whole test process according to the protocol requirements.
• Exclusion Criteria:
• • 1. The researcher determined that the target eye currently has or had macular lesions such as macular hiatal hole or macular neovascularization;
• • 2. Have other eye conditions that may prevent surgery or interfere with interpretation of the study endpoint, such as glaucoma, diabetic retinopathy, eye or periocular infections, active endophthalmitis, etc.
• • 3. Within 3 months prior to enrollment, the study eye had received any intraocular surgery, such as phacoemulsification cataract extraction.
• • 4. The study eye had undergone retinal reattachment or vitrectomy.
• • 5. Participants who had participated in any drug or medical device clinical trial within 3 months before enrollment;
• • 6. Previously treatment of either eye with gene therapy or stem cell therapy for RP and other ocular diseases, including but not limited to viral vector gene therapy, RNA therapy.
• • 7. Treatment with medications that may affect the efficacy and safety evaluation of the investigational product within 3 months prior to enrollment (e.g., ranibizumab, bevacizumab, aflibercept, conbercept).
• • 8. Known allergy to the drug planned to be used in the study.