NCT07307469

Compassionate Administration of ZVS101e Injection for Extended Treatment

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Chigenovo Co., Ltd · Network
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Patients With Bietti Crystalline Corneoretinal Dystrophy (Carrying Biallelic CYP4V2 Mutations)

Interventions

Type	Name	Description
DRUG	ZVS101e	ZVS101e is a recombinant adeno-associated virus serotype 8 (rAAV8) vector expressing human CYP4V2 protein

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-01-01
• Completion: 2027-07-01
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

5 sites across 1 country: China