To provide treatment options for the control group of subjects who completed the 52-week follow-up of the Phase III clinical trial (Protocol number: ZYA-2024-001) of ZVS101e in subjects with crystalline retinal degeneration (BCD).
The trial period lasts for a total of 8 weeks, including a 4-week screening period, a administration period, and visits on the 1st day, 7th day, and 4th week after administration. The patients were followed up at the research center on the 1st day, 7th day and 4th week after administration to evaluate the safety.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
ZVS101e is a recombinant adeno-associated virus serotype 8 (rAAV8) vector expressing human CYP4V2 protein
Peking University Third Hospital
Beijing, Beijing Municipality, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Safety evaluation
Incidence of adverse events
Time frame: 4 weeks
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Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China