[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526954":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":30,"locations":36,"responsibleParty":55,"collaborators":29,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":29,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":29,"enrollmentInfo":66,"targetDuration":29,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":29,"overallStatus":39,"whyStopped":29,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Shanghai Refreshgene Technology Co., Ltd.","INDUSTRY",[8,14,17,20],{"label":9,"type":10,"description":11,"interventionNames":12},"RRG001 Dose1","EXPERIMENTAL","Frequency of administration: one time injection.",[13],"Drug: RRG001",{"label":15,"type":10,"description":11,"interventionNames":16},"RRG001 Dose2",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"RRG001 Dose3",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"RRG001 Dose4",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","RRG001","Administered via Subretinal injection. Dosage form: injection solution.",[9,15,18,21],null,[31],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},"Xiaorong Li, Master","CONTACT","8602223346434","xiaorong.li@163.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Tianjin Medical University Eye Hospital","RECRUITING","Tianjin","Tianjin Municipality","300384","China","CN",{"type":46,"coordinates":47},"Point",[48,49],117.17667,39.14222,{"lat":49,"lon":48},[52],{"name":53,"role":33,"phone":34,"phoneExt":29,"email":54},"Li Xiaorong, Professor","xiaorli@163.com",{"type":56,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100526954","phase-1-safety-and-efficacy-of-rrg001-gene-therapy-in-subjects-with-neovascular-age-related-macular-degeneration-namd-100526954",false,"NCT06141460","Safety and Efficacy of RRG001 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)","A Phase I\u002FIIa, Dose-escalation and Dose-extension Study to Evaluate the Safety and Efficacy of Single Subretinal Injection of RRG001 in Subjects With Neovascular Age-related Macular Degeneration","Inclusion Criteria:\n\n* Subjects that are willing and able to follow study procedures.\n* Patinets ≥50 years old.\n* Clinically diagnosed with CNV secondary to nAMD.\n* BCVA of the study eye is ≥5 letters and ≤73 letters(Snellen 20\u002F800\\~20\u002F40), as well as that of the other eye ≥19 letters(Snellen 20\u002F400).\n* Responding to anti-VEGF\n\nExclusion Criteria:\n\n* Presence of any other eye diseases other than nAMD in study eye that would affect the treatment or confusing the interpretation of the study results , as judged by the investigator.\n* CNV or macular edema in the study eye secondary to any causes other than AMD.\n* Uncontrolled glaucoma.\n* Uncontrolled hypertension despite medication.\n* Pregnant or lactating women or individuals with reproductive potential who are unwilling to take effective contraception during the study period.","ALL","50 Years",{"count":67,"type":68},48,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE1","PHASE2","A Phase I\u002FIIa, Dose-escalation and Dose-expansion Study to Evaluate the Safety and Efficacy of Single Subretinal Injection of RRG001 in Subjects With Neovascular Age-related Macular Degeneration",[75],"Neovascular Age-related Macular Degeneration","2024-11-12",{"date":78,"type":79},"2024-11-14","ACTUAL",{"date":81,"type":79},"2023-12-12",{"date":83,"type":68},"2030-12-31",{"name":5,"class":6},1]