Tests ZVS203e in adults with retinitis pigmentosa caused by an RHO gene change
Tests ZVS203e, injected under the retina, in adults with retinitis pigmentosa.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of ZVS203e in the Treatment of Retinitis Pigmentosa Caused by RHO Gene Mutation
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1/2
Where in China
- Peking University Third HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chigenovo Co., Ltd
- Trial code
- NCT06952842
- Record updated
- 17 June 2026
- Original description
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.Read full original descriptionShow less
A Single-Arm, Open-Label, Phase 1/2 Clinical Trial of ZVS203e in Subjects With Retinitis Pigmentosa Associated With RHO Mutation
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.
Inclusion: Patients with a clinical diagnosis of retinitis pigmentosa (RP) (aged 18 years or older); RHO (c.403C>T, p.R135W) gene site-specific mutation was confirmed by genetic testing, and no other ophthalmic genetic diseases were complicated; The researchers judged that the target eye had viable retinal photoreceptor cells and retinal pigment epithelial cells; 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); The subject and his or her spouse agree to use effective contraception during the trial period and for at least 1 year after dosing; Voluntarily participate in clinical trials and sign informed consent, and can complete the whole test process according to the protocol requirements.
Exclusion: Within 3 months prior to enrollment, the study eye had received any intraocular surgery, such as phacoemulsification cataract extraction; Participants who had participated in any drug or medical device clinical trial within 3 months before enrollment; 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; 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); 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; Known allergy to the drug planned to be used in the study; The researcher determined that the target eye currently has or had macular lesions such as macular hiatal hole or macular neovascularization; The study eye had undergone retinal reattachment or vitrectomy.