[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509666":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":40,"locations":49,"responsibleParty":65,"collaborators":67,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":28,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":28,"enrollmentInfo":81,"targetDuration":28,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":28,"overallStatus":51,"whyStopped":28,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Frontera Therapeutics","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"FT003 Dose 1","EXPERIMENTAL","Low dose of FT-003",[13],"Genetic: FT-003",{"label":15,"type":10,"description":16,"interventionNames":17},"FT003 Dose 2","Mid dose of FT-003",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"FT003 Dose 3","High dose of FT-003",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"GENETIC","FT-003","Administration via intraocular injection",[9,15,19],null,[30,34,37],{"name":31,"affiliation":32,"role":33},"Xiaorong Li, Professor","Tianjin Medical University Eye Hospital","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":33},"Hanyi Min, Professor","Peking Union Medical College Hospital",{"name":38,"affiliation":39,"role":33},"Guangming Wan, Professor","The First Affiliated Hospital of Zhengzhou University",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":28,"email":45},"Xinyan Li","CONTACT","+862158206061","Xinyan.li@fronteratherapeutics.com",{"name":47,"role":43,"phone":44,"phoneExt":28,"email":48},"Minghui Xue","minghui.xue@fronteratherapeutics.com",[50],{"facility":32,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Tianjin","Tianjin,China","300392","China","CN",{"type":58,"coordinates":59},"Point",[60,61],117.17667,39.14222,{"lat":61,"lon":60},[64],{"name":31,"role":43,"phone":28,"phoneExt":28,"email":28},{"type":66,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[68,70,71],{"name":32,"class":69},"OTHER",{"name":36,"class":69},{"name":39,"class":69},"100509666","phase-1-gene-therapy-for-diabetic-macular-edema-100509666",false,"NCT05916391","Gene Therapy for Diabetic Macular Edema","An Open-label, Multy-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FT-003 in Subjects With Diabetic Macular Edema","Inclusion Criteria:\n\n* Subjects that are willing and able to follow study procedures;\n* Female or male patients ≥18 years old at the time of signing the ICF;\n* Clinically diagnosed with CI-DME\n* HbA1c≤10%\n* The best corrected visual acuity (BCVA) of the studied eye is ≤ 73 letters\n\nExclusion Criteria:\n\n* Presence of any other intraocular diseases other than CI-DME in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator","ALL","18 Years",{"count":82,"type":83},18,"ESTIMATED","INTERVENTIONAL",[86],"PHASE1","FT-003 is a gene therapy product developed for the treatment of central involvement diabetic macular edema (CI-DME). Diabetic retinopathy is one of the most common microvascular complications of diabetes mellitus, and diabetic macular edema is the main cause of vision loss in patients with diabetic retinopathy. In the latest guidelines, anti-VEGF therapy is preferred for CI-DME. Administration of FT-003 has the potential to treat CI-DME by providing intraocular protein which is durable expressed in therapeutic level. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with CI-DME receiving anti-VEGF therapy in clinical practice.",[89],"Diabetic Macular Edema","2023-06-14",{"date":92,"type":93},"2023-06-23","ACTUAL",{"date":95,"type":93},"2023-05-19",{"date":97,"type":83},"2028-05-01",{"name":5,"class":6},1]