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.
• 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.