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

Recruiting Phase 1 Phase 2 Interventional Study
Retinitis Pigmentosa
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
18 (estimated)
Sponsor
Chigenovo Co., Ltd · Research network
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About This Trial

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.

Trial Locations
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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 ta…
Contacts

Jinlu Zhang, MD

15810570898

zhangjinlu@chinagene.cc

CONTACT