[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fuchs-endothelial-corneal-dysfunction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fuchs-endothelial-corneal-dysfunction":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100621310","phase-3-aurn001-efficacy-in-participants-with-corneal-edema-secondary-to-corneal-endothelial-dysfunction-100621310",false,"NCT07368959","AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction","ASTRA: A Phase 3 Multi-center, Randomized, Double-Masked, Prospective Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-3)","Key Ocular Inclusion Criteria:\n\n(All ocular criteria apply to the study eye unless noted otherwise)\n\n* Have corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)\n* BCVA between 65 ETDRS letters (approximate 20\u002F50 Snellen equivalent) and 5 ETDRS letters (approximate 20\u002F800 Snellen equivalent)\n* Be pseudophakic with PCIOL\n\nKey Ocular Exclusion Criteria:\n\n(All ocular criteria apply to the study eye unless noted otherwise)\n\n* Have progressive corneal dystrophies or degenerations\n* Have visually significant corneal or other ocular pathologies\n\nOther inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of this study is to assess the efficacy and safety of single injection dose of AURN001 compared with placebo in adult participants with corneal edema secondary to corneal endothelial dysfunction.",[26,27,28,29],"Corneal Edema","Corneal Endothelial Dysfunction","Fuchs Endothelial Corneal Dysfunction","Pseudophakic Bullous Keratopathy (PBK)",[31,32,33,34,35,36,37,38,39,40,41,42,43],"Best Corrected Visual Acuity","Central corneal thickness","Human Corneal Endothelial Cells","Neltependocel","Postsurgical endothelial dysfunction","Keratoplasty","Pseudophakic Corneal Edema (PCE)","Corneal Endothelial Cells","Endothelial Cells","AURN001","Y-27632","Endothelial Keratoplasty","Corneal Endothelial Cell Therapy","RECRUITING","2026-05-21",{"date":47,"type":48},"2026-05-22","ACTUAL",{"date":50,"type":48},"2026-02-19",{"date":52,"type":20},"2028-01",{"name":54,"class":55},"Aurion Biotech","INDUSTRY",12]