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ZVS101e in Patients With Bietti's Crystalline Dystrophy
Sponsor: Chigenovo Co., Ltd
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.
Official title: Clinical Translation and Application Protocol for ZVS101e in the Gene Therapy of Bietti Crystalline Corneoretinal Dystrophy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-07-30
Completion Date
2035-12
Last Updated
2026-06-17
Healthy Volunteers
No
Interventions
ZVS101e
ZVS101e injection contains a recombinant adeno-associated virus serotype 8 (rAAV8) vector that expresses human CYP4V2 protein.
Locations (2)
Boao Super Hospital
Qionghai, Hainan, China
Hainan Boao Ophthalmology Center, Zhongshan Ophthalmic Center, Sun Yat-sen University
Qionghai, Hainan, China