Efficacy and Safety of ZVS101e in Patients With Bietti 's Crystalline Dystrophy

Last updated: January 1, 2025
Sponsor: Chigenovo Co., Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

Retina

Retinitis Pigmentosa

Treatment

ZVS101e

Clinical Study ID

NCT06743646
ZYA-2024-001
  • Ages > 18
  • All Genders

Study Summary

This is a multi-center, randomized and controlled phase 3 clinical trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. All of the following inclusion criteria should be met for enrollment into the trial:

  2. Fully understand the purpose and requirements of this trial, voluntarily participatein the clinical trial and sign the informed consent form, and be able to completeall trial procedures as required by the protocol;

  3. Clinical diagnosis of Bietti's crystalline dystrophy (BCD), age≥18 years ;

  4. Genetic testing confirmed biallelic CYP4V2 mutations without other ophthalmicgenetic diseases;

  5. Best-corrected visual acuity of 5-60 ETDRS letters.

Exclusion

Exclusion Criteria:

  1. The study eye has or has had macular lesions such as macular hole or macularneovascularization; glaucoma, diabetic retinopathy, or any other ocular disease thatmay preclude surgery or interfere with interpretation of the study endpoints

  2. The study eye had received the following intraocular surgical treatments: retinalreattachment, vitrectomy;

  3. The study eye had received any intraocular surgery, such as phacoemulsification 3months prior to enrollment;

  4. Previously treatment of either eye with gene therapy or stem cell therapy for BCDand other ocular diseases, including but not limited to viral vector gene therapy,RNA therapy;

  5. Pregnant or lactating women;

Study Design

Total Participants: 62
Treatment Group(s): 1
Primary Treatment: ZVS101e
Phase: 3
Study Start date:
December 27, 2024
Estimated Completion Date:
June 30, 2030

Study Description

Subjects who have signed the written informed consent form and who were eligible for enrollment after screening will be randomly assigned to the treatment group or untreated control group. Each Participant in the treatment group will receive a unilateral subretinal injection of ZVS101e in the study eye.

Participants in the control group will receive no treatment during the first 52 weeks of enrollment.

Connect with a study center

  • Peking University Third Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The First Affiliated Hospital of Harbin Medical University

    Haerbin, Heilongjiang
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Site Not Available

  • Tianjin Medical University Eye Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

  • Eye Hospital, Wenzhou Medical University

    Wenzhou, Zhejiang
    China

    Site Not Available

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