[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551996":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":143,"collaborators":28,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":28,"eligibilityCriteria":151,"healthyVolunteers":147,"sex":152,"minAge":153,"maxAge":28,"enrollmentInfo":154,"targetDuration":28,"studyType":157,"phases":158,"briefSummary":161,"conditions":162,"keywords":167,"overallStatus":43,"whyStopped":28,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"Ascidian Therapeutics, Inc","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Low dose of ACDN-01","EXPERIMENTAL","One time low dose of ACDN-01.",[13],"Drug: ACDN-01",{"label":15,"type":10,"description":16,"interventionNames":17},"Mid-dose of ACDN-01","One time mid-dose of ACDN-01.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"High dose of ACDN-01","One time high dose of ACDN-01.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","ACDN-01","ACDN-01 is an AAV-based vector carrying a DNA construct encoding for an ABCA4 RNA exon editor. One time administration is via subretinal injection.",[19,9,15],null,[30],{"name":31,"affiliation":32,"role":33},"Alia Rashid","Ascidian Therapeutics","STUDY_DIRECTOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":28,"email":39},"Associate Director, Clinical Operations","CONTACT","207-573-0412","researchtrials@ascidian-tx.com",[41,55,65,74,84,94,104,114,124,134],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":28},"University of San Francisco","RECRUITING","San Francisco","California","94158","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-122.41942,37.77493,{"lat":53,"lon":52},{"facility":56,"status":43,"city":57,"state":58,"zip":59,"country":47,"countryCode":48,"cosmosGeoPoint":60,"geoPoint":64,"contacts":28},"Vitreo Retinal Associates","Gainesville","Florida","32607",{"type":50,"coordinates":61},[62,63],-82.32483,29.65163,{"lat":63,"lon":62},{"facility":66,"status":43,"city":67,"state":58,"zip":68,"country":47,"countryCode":48,"cosmosGeoPoint":69,"geoPoint":73,"contacts":28},"Bascom Palmer Eye Institute","Miami","33136",{"type":50,"coordinates":70},[71,72],-80.19366,25.77427,{"lat":72,"lon":71},{"facility":75,"status":43,"city":76,"state":77,"zip":78,"country":47,"countryCode":48,"cosmosGeoPoint":79,"geoPoint":83,"contacts":28},"Wilmer Eye Institute at John Hopkins","Baltimore","Maryland","21218",{"type":50,"coordinates":80},[81,82],-76.61219,39.29038,{"lat":82,"lon":81},{"facility":85,"status":43,"city":86,"state":87,"zip":88,"country":47,"countryCode":48,"cosmosGeoPoint":89,"geoPoint":93,"contacts":28},"Massachusetts Eye and Ear","Boston","Massachusetts","02114",{"type":50,"coordinates":90},[91,92],-71.05977,42.35843,{"lat":92,"lon":91},{"facility":95,"status":43,"city":96,"state":97,"zip":98,"country":47,"countryCode":48,"cosmosGeoPoint":99,"geoPoint":103,"contacts":28},"University of Michigan Kellogg Eye Center","Ann Arbor","Michigan","48105",{"type":50,"coordinates":100},[101,102],-83.74088,42.27756,{"lat":102,"lon":101},{"facility":105,"status":43,"city":106,"state":107,"zip":108,"country":47,"countryCode":48,"cosmosGeoPoint":109,"geoPoint":113,"contacts":28},"Cincinnati Eye Institute","Cincinnati","Ohio","45245",{"type":50,"coordinates":110},[111,112],-84.51439,39.12711,{"lat":112,"lon":111},{"facility":115,"status":43,"city":116,"state":117,"zip":118,"country":47,"countryCode":48,"cosmosGeoPoint":119,"geoPoint":123,"contacts":28},"Casey Eye Institute OHSU","Portland","Oregon","97239",{"type":50,"coordinates":120},[121,122],-122.67621,45.52345,{"lat":122,"lon":121},{"facility":125,"status":43,"city":126,"state":127,"zip":128,"country":47,"countryCode":48,"cosmosGeoPoint":129,"geoPoint":133,"contacts":28},"Retina Foundation of the Southwest","Dallas","Texas","75382",{"type":50,"coordinates":130},[131,132],-96.80667,32.78306,{"lat":132,"lon":131},{"facility":135,"status":43,"city":136,"state":127,"zip":137,"country":47,"countryCode":48,"cosmosGeoPoint":138,"geoPoint":142,"contacts":28},"Retina Consultants of Texas","Houston","77401",{"type":50,"coordinates":139},[140,141],-95.36327,29.76328,{"lat":141,"lon":140},{"type":144,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100551996","phase-1-study-to-evaluate-acdn-01-in-abca4-related-stargardt-retinopathy-stellar-100551996",false,"NCT06467344","Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR)","ACDN-01-001: Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Subretinal ACDN-01 in Participants With ABCA4-related Retinopathy","Key Inclusion Criteria:\n\n* Presence of mutations in the ABCA4 gene\n* ABCA4 retinopathy phenotype (Stargardt disease type 1 or cone-rod dystrophy)\n* Area of atrophy located in the macula of the study eye\n* BCVA of 20\u002F50 (0.4 logMAR) or worse\n\nKey Exclusion Criteria:\n\n* The presence of pathogenic or likely pathogenic mutations in other genes known to cause cone-rod dystrophy or Stargardt maculopathy\n* Retinal disease other than ABCA4-related retinopathy\n* Presence of a medical condition (systemic or ophthalmic), psychiatric condition, including substance abuse disorder, or physical examination or laboratory finding that may in the opinion of the principal investigator and sponsor preclude adherence to the scheduled study visits, safe participation in the study, or affect the results of the study.","ALL","12 Years",{"count":155,"type":156},15,"ESTIMATED","INTERVENTIONAL",[159,160],"PHASE1","PHASE2","This study is an open-label, single ascending dose clinical trial in participants who have ABCA4-related retinopathies. This is the first-in-human clinical trial in which ACDN-01 will be evaluated for safety, tolerability, and preliminary efficacy following a single subretinal injection of ACDN-01.",[163,164,165,166],"Stargardt Disease","Cone Rod Dystrophy","Juvenile Macular Degeneration","Stargardt Disease 1",[168,169,163,170,171,172,173,174,175,176,177,178,179],"ABCA4","ABCA4-related retinopathy","Stargardt macular dystrophy","Cone rod dystrophy","Gene editing","RNA","Gene Therapy","Exon editing","IRD","Inherited retinal disease","Inherited retinal dystrophy","Inherited retinal degeneration","2025-11-25",{"date":182,"type":183},"2025-12-02","ACTUAL",{"date":185,"type":183},"2024-06-11",{"date":187,"type":156},"2030-12-01",{"name":5,"class":6},10]