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 Bietti crystalline corneoretinal dystrophy (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 will be 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
NA
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
Incidence and severity of adverse events and serious adverse events
This study specifies that the recording of adverse events begins on Day 0 (D0). Adverse events (AEs) include, but are not limited to, the following: 1. Worsening of pre-existing medical conditions/diseases (i.e., conditions present prior to enrollment in the clinical trial), including exacerbation of symptoms, signs, frequency of episodes, or abnormal laboratory test results; 2. Any newly occurring adverse medical conditions (including symptoms, signs, or newly diagnosed diseases); 3. Abnormal laboratory test values or results with clinical significance, or other safety assessments (e.g., vital signs measurements).
Time frame: 4 weeks
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Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China