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NOT YET RECRUITING
NCT07653971
NA

ZVS101e in Patients With Bietti's Crystalline Dystrophy

Sponsor: Chigenovo Co., Ltd

View on ClinicalTrials.gov

Summary

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.

Official title: Clinical Translation and Application Protocol for ZVS101e in the Gene Therapy of Bietti Crystalline Corneoretinal Dystrophy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-07-30

Completion Date

2035-12

Last Updated

2026-06-17

Healthy Volunteers

No

Interventions

DRUG

ZVS101e

ZVS101e injection contains a recombinant adeno-associated virus serotype 8 (rAAV8) vector that expresses human CYP4V2 protein.

Locations (2)

Boao Super Hospital

Qionghai, Hainan, China

Hainan Boao Ophthalmology Center, Zhongshan Ophthalmic Center, Sun Yat-sen University

Qionghai, Hainan, China