[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chigenovo Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100589317","phase-1-safety-and-efficacy-of-zvs203e-in-the-treatment-of-retinitis-pigmentosa-caused-by-rho-gene-mutation-100589317",false,"NCT06952842","Safety and Efficacy of ZVS203e in the Treatment of Retinitis Pigmentosa Caused by RHO Gene Mutation","A Single-Arm, Open-Label, Phase 1\u002F2 Clinical Trial of ZVS203e in Subjects With Retinitis Pigmentosa Associated With RHO Mutation","ZVS203e","Inclusion Criteria:\n\n1. Patients with a clinical diagnosis of retinitis pigmentosa (RP) (aged 18 years or older);\n2. RHO (c.403C\\>T, p.R135W) gene site-specific mutation was confirmed by genetic testing, and no other ophthalmic genetic diseases were complicated;\n3. The researchers judged that the target eye had viable retinal photoreceptor cells and retinal pigment epithelial cells;\n4. The best corrected visual acuity of the target eye is between 2.0 LogMAR and 0.5 LogMAR (including 2.0 LogMAR and 0.5 LogMAR, which is equivalent to a number of fingers to 60 letters);\n5. The subject and his or her spouse agree to use effective contraception during the trial period and for at least 1 year after dosing;\n6. Voluntarily participate in clinical trials and sign informed consent, and can complete the whole test process according to the protocol requirements.\n\nExclusion Criteria:\n\n1. The researcher determined that the target eye currently has or had macular lesions such as macular hiatal hole or macular neovascularization;\n2. Have other eye conditions that may prevent surgery or interfere with interpretation of the study endpoint, such as glaucoma, diabetic retinopathy, eye or periocular infections, active endophthalmitis, etc.\n3. Within 3 months prior to enrollment, the study eye had received any intraocular surgery, such as phacoemulsification cataract extraction.\n4. The study eye had undergone retinal reattachment or vitrectomy.\n5. Participants who had participated in any drug or medical device clinical trial within 3 months before enrollment;\n6. Previously treatment of either eye with gene therapy or stem cell therapy for RP and other ocular diseases, including but not limited to viral vector gene therapy, RNA therapy.\n7. Treatment with medications that may affect the efficacy and safety evaluation of the investigational product within 3 months prior to enrollment (e.g., ranibizumab, bevacizumab, aflibercept, conbercept).\n8. Known allergy to the drug planned to be used in the study.","ALL","18 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This trial employs a single-arm, open-label seamless Phase I\u002FII design, consisting of two stages: Phase I dose exploration and Phase II dose expansion.The primary objective of this trial is to evaluate the safety, tolerability, and efficacy of subretinal injection of ZVS203e solution.",[28],"Retinitis Pigmentosa",[30,15,31,32],"Gene editing","RHO","Retinitis pigmentosa","RECRUITING","2026-06-15",{"date":36,"type":37},"2026-06-17","ACTUAL",{"date":39,"type":37},"2025-08-04",{"date":41,"type":21},"2045-06-18",{"name":43,"class":44},"Chigenovo Co., Ltd","NETWORK",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100642030","zvs101e-in-patients-with-biettis-crystalline-dystrophy-100642030","NCT07653971","ZVS101e in Patients With Bietti's Crystalline Dystrophy","Clinical Translation and Application Protocol for ZVS101e in the Gene Therapy of Bietti Crystalline Corneoretinal Dystrophy","ZVS101e-BCD","Inclusion Criteria:\n\n1. Voluntarily participate in the research and sign the informed consent form, and be willing to complete the entire process according to the protocol requirements;\n2. Clinically diagnosed with Bietti's Crystalline Dystrophy (BCD), age ≥ 18 years;\n3. Confirmed by genetic testing to carry homozygous or compound heterozygous mutations in CYP4V2, and not complicated with other ophthalmic genetic diseases;\n4. Target eye BCVA ≤ 60 ETDRS letters.\n\nExclusion Criteria:\n\nSubjects will be excluded if they meet any 1 of the following exclusion criteria:\n\n1. The target eye currently has or has a history of macular lesions; suffers from ocular diseases that may hinder surgery or interfere with the interpretation of study endpoints;\n2. The target eye has previously undergone retinal reattachment surgery, vitrectomy, or any intraocular surgery within 3 months before enrollment;\n3. Within 1 month before enrollment, suffered from viral infectious diseases that may affect the evaluation of the efficacy and safety of the investigational drug, or received antiviral vaccines;\n4. The target eye has previously received gene therapy or stem cell therapy for BCD or other ocular diseases;\n5. Known allergy to the drugs planned for use in the study;\n6. The laboratory abnormalities are considered clinically significant;\n7. Pregnant or lactating females.",{"count":55,"type":21},300,[57],"NA","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.\n\nParticipants will:\n\nundergo 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.",[60,61],"Bietti's Crystalline Dystrophy","Bietti Crystalline Corneoretinal Dystrophy",[60,63,64,65,61],"ZVS101e","AAV8-hCYP4V2","gene replacement treatment","NOT_YET_RECRUITING","2026-06-12",{"date":36,"type":37},{"date":70,"type":21},"2026-07-30",{"date":72,"type":21},"2035-12",{"name":43,"class":44},""]