An interventional study of ZVS101e in Bietti Crystalline Corneoretinal Dystrophy, sponsored by Chigenovo Co., Ltd. Enrolling by invitation at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Chigenovo Co., Ltd · Not applicable, Interventional, and Treatment
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.
Chigenovo Co., Ltd is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The following laboratory test abnormalities have clinical significance:
Liver function: ALT or AST>2 times the upper limit of the normal value; Abnormal coagulation function (prothrombin time ≥ the upper limit of normal value by 3 seconds, activated partial thromboplastin time ≥ the upper limit of normal value by 10 seconds).
The study eye of the subject receives a subretinal injection of ZVS101e.
Drug: ZVS101e
ZVS101e is a recombinant adeno-associated virus serotype 8 (rAAV8) vector expressing human CYP4V2 protein
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
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Bietti Crystalline Dystrophy
Chigenovo Co., Ltd