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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
ZVS101e injection contains a recombinant adeno-associated virus serotype 8 (rAAV8) vector that expresses human CYP4V2 protein.
Boao Super Hospital
Qionghai, Hainan, China
Hainan Boao Ophthalmology Center, Zhongshan Ophthalmic Center, Sun Yat-sen University
Qionghai, Hainan, China
Change from baseline in Best corrected visual acuity (BCVA)
Time frame: From enrollment to the end of treatment at 52 weeks
The incidence and severity of adverse events and serious adverse events
Time frame: From enrollment to the end of treatment at 52 weeks
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