NCT06952842 Safety and Efficacy of ZVS203e in the Treatment of Retinitis Pigmentosa Caused by RHO Gene Mutation
| NCT ID | NCT06952842 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Chigenovo Co., Ltd |
| Condition | Retinitis Pigmentosa |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2025-08-04 |
| Primary Completion | 2030-06-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2025-08-04 with a primary completion date of 2030-06-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This trial employs a single-arm, open-label seamless Phase I/II design, consisting of two stages: Phase I dose exploration and Phase II dose expansion.The primary objective of this trial is to evaluate the safety, tolerability, and efficacy of subretinal injection of ZVS203e solution.
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.
Contact & Investigator
Hongliang Dou, M.D.
PRINCIPAL INVESTIGATOR
Peking University Third Hospital
Frequently Asked Questions
Who can join the NCT06952842 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Retinitis Pigmentosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06952842 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06952842 currently recruiting?
Yes, NCT06952842 is actively recruiting participants. Contact the research team at zhangjinlu@chinagene.cc for enrollment information.
Where is the NCT06952842 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06952842 clinical trial?
NCT06952842 is sponsored by Chigenovo Co., Ltd. The principal investigator is Hongliang Dou, M.D. at Peking University Third Hospital. The trial plans to enroll 18 participants.