ZVS101e in Patients With Bietti's Crystalline Dystrophy
Condition(s) studied
Investigational drug(s) / intervention(s)
ZVS101e: ZVS101e injection contains a recombinant adeno-associated virus serotype 8 (rAAV8) vector that expresses human CYP4V2 protein.
Study summary
The goal of this clinical trial is to evaluate the safety and early effectiveness of ZVS101e in patients with Bietti crystalline dystrophy who meet the eligibility criteria for treatment under the translational application program in the Hainan Boao Lecheng International Medical Tourism Pilot Zone.
Participants will:
undergo screening and baseline assessments to confirm eligibility; receive a single subretinal injection of ZVS101e in the study eye; complete follow-up visits over 4 weeks after treatment for safety monitoring and assessment of early effectiveness.
Eligibility
Primary outcome measure(s)
- Change from baseline in Best corrected visual acuity (BCVA) — From enrollment to the end of treatment at 52 weeks
- The incidence and severity of adverse events and serious adverse events — From enrollment to the end of treatment at 52 weeks
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Boao Super Hospital | Qionghai | Hainan | |
| Hainan Boao Ophthalmology Center, Zhongshan Ophthalmic Center, Sun Yat-sen University | Qionghai | Hainan |
More Chigenovo Co., Ltd trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07653971 on ClinicalTrials.gov ↗ ← All trials in China