Phase
Condition
Retina
Retinitis Pigmentosa
Treatment
ZVS101e
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
All of the following inclusion criteria should be met for enrollment into the trial:
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;
Clinical diagnosis of Bietti's crystalline dystrophy (BCD), age≥18 years ;
Genetic testing confirmed biallelic CYP4V2 mutations without other ophthalmicgenetic diseases;
Best-corrected visual acuity of 5-60 ETDRS letters.
Exclusion
Exclusion Criteria:
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
The study eye had received the following intraocular surgical treatments: retinalreattachment, vitrectomy;
The study eye had received any intraocular surgery, such as phacoemulsification 3months prior to enrollment;
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;
Pregnant or lactating women;
Study Design
Study Description
Connect with a study center
Peking University Third Hospital
Beijing, Beijing
ChinaSite Not Available
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong
ChinaSite Not Available
The First Affiliated Hospital of Harbin Medical University
Haerbin, Heilongjiang
ChinaSite Not Available
Henan Provincial People's Hospital
Zhengzhou, Henan
ChinaSite Not Available
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu, Sichuan
ChinaSite Not Available
Tianjin Medical University Eye Hospital
Tianjin, Tianjin
ChinaActive - Recruiting
Eye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang
ChinaSite Not Available

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