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Compassionate Administration of ZVS101e Injection for Extended Treatment

NCT ID: NCT07307469

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2027-07-31

Brief Summary

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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

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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

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Safety evaluation

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Group Type EXPERIMENTAL

ZVS101e

Intervention Type DRUG

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

Interventions

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ZVS101e

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects who were randomly assigned as the control group in a multicenter, randomized controlled, Phase III clinical trial (Protocol number: ZYA-2024-001) on the efficacy and safety of a single subretinal injection of ZVS101e in subjects with crystalline retinal degeneration (BCD) and completed a 52-week safety follow-up were included.
2. Voluntarily participate in clinical trials and sign informed consent forms, and be willing to complete all trial procedures as required by the protocol.
3. Study the BCVA of the eye ≤60 ETDRS letters.

Exclusion Criteria

1. The study eye currently has or has had macular degeneration such as macular holes or neovascularization in the macular area; Other ocular diseases such as glaucoma and diabetic retinopathy that may hinder surgery or interfere with the interpretation of the study endpoint.
2. The study eye had undergone retinal repositioning surgery, vitrectomy, or had undergone any intraocular surgery within 3 months prior to enrollment, such as phacoemulsification for cataract.
3. Within one month prior to enrollment, the patient had a viral infectious disease that may affect the efficacy and safety evaluation of the investigational drug or had received an antiviral vaccine.
4. Any eye has previously received gene therapy or stem cell therapy for BCD and other ocular diseases, including but not limited to other viral vector gene therapies, mRNA therapies, etc.
5. Known to be allergic to the drugs planned to be used in the study.
6. 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).
7. Pregnant or lactating women.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chigenovo Co., Ltd

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Other Identifiers

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ZYA-2025-004

Identifier Type: -

Identifier Source: org_study_id