[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563985":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":19,"responsibleParty":29,"collaborators":19,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":37,"eligibilityCriteria":38,"healthyVolunteers":33,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":19,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":57,"whyStopped":19,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":19},{"fullName":5,"class":6},"HuidaGene Therapeutics Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HG202","EXPERIMENTAL","The study will enroll up to 3 dose cohorts：Low dose\u002FMiddle dose\u002FHigh dose",[13],"Genetic: HG202",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"GENETIC","Method of Administration: Once unilateral subretinal injection; The duration of the study includes a 4-week screening period, enrollment visit, treatment visit and 52 weeks follow-up period, 4 more years long term follow up as an extension study.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Study Director","STUDY_DIRECTOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","732-318-9873","HG20202@huidagene.com",{"type":30,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100563985","phase-1-open-label-dose-escalation-study-for-crisprcas13--rna-targeting-therapy-for-the-treatment-of-neovascular-age-related-macular-degeneration-in-phase-i-trial-100563985",false,"NCT06623279","Open-laBel Dose-escalation Study for CRISPR\u002Fcas13- Rna TargetInG THerapy for the Treatment of Neovascular Age-related Macular Degeneration in Phase I Trial","A Phase 1, Open-label, Multiple-cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of HG202 High-fidelity CRISPR-Cas13 (hfCas13Y) RNA-targeting Therapy for Neovascular Age-related Macular Degeneration (nAMD)","BRIGHT","Inclusion Criteria:\n\n* Males or females ≥ 50 and ≤ 85 years at the time of signing the ICF;\n* Active macular choroidal neovascularization (MNV) secondary to nAMD in the study eye;\n* Sentinel (1st) subject for each dose cohort must have a BCVA ≤ 20\u002F63 and ≥ 20\u002F400 (≤63 and ≥ 19 ETDRS letters) in the study eye. Following the sentinel subject evaluation, the rest of the subjects in the dose cohort must have a BCVA between ≤ 20\u002F40 and ≥ 20\u002F400 (≤ 73 and ≥ 19 ETDRS letters) in the study eye.\n* Able to perform visual acuity and retinal function tests and able and willing to comply with study procedures for this clinical trial.\n\nExclusion Criteria:\n\n* Retinal or subretinal hemorrhage, scarring, or fibrosis of greater than 50% of the total lesion in the study eye;\n* Other ocular diseases that may affect central vision in the study eye;\n* Any other cause of CNV than nAMD in the study eye\n* Uncontrolled glaucoma in the study eye;\n* History or presence of corneal transplant or corneal dystrophy in the study eye;\n* History of other intraocular surgery in the study eye within 3 months prior to baseline;\n* Prior gene therapy or oligonucleotide therapy;\n* Other conditions judged by the investigator as inappropriate for the study.","ALL","50 Years","85 Years",{"count":43,"type":44},15,"ESTIMATED","INTERVENTIONAL",[47],"PHASE1","Age-related macular degeneration (AMD) leads to severe and irreversible vision loss, while neovascular AMD (nAMD) accounts for 80-90% of AMD blindness. Current anti-VEGF therapies are the standard of care, but these therapies require life-long repeated intraocular injections. These frequent intravitreal injections increase the risk of complications, including submacular hemorrhage, intraocular hypertension, inflammation, and retinal detachment. Therefore, repeated treatments for nAMD place a substantial burden on healthcare systems, patients, and their caregivers. Additionally, approximately 25-35% of individuals with aggressive nAMD show suboptimal responses to the anti-VEGF therapies, experience treatment-extended failure, or require intensive, frequent intraocular injections, and do not prevent irreversible vision loss.\n\nHG202 is a CRISPR\u002FCas13 RNA-editing therapy delivered through one single AAV vector to partially knock down the expression of VEGFA and thus inhibit CNV formation in AMD. The long-term, stable delivery of HG202 following a one-time gene-editing therapy treatment for nAMD may potentially reduce the frequent injections and the potential risks of currently available anti-VEGF therapies since it does not rely on the long-term expression of anti-VEGF antibodies.",[50],"Neovascular Age-Related Macular Degeneration (nAMD)",[52,53,54,55,56,9],"Macular Degeneration","nAMD","wAMD","Gene-editing","CRISPR","NOT_YET_RECRUITING","2024-09-30",{"date":60,"type":61},"2024-10-02","ACTUAL",{"date":63,"type":44},"2025-04-01",{"date":65,"type":44},"2031-02-01",{"name":5,"class":6}]