[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609488":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":38,"locations":45,"responsibleParty":217,"collaborators":33,"id":219,"slug":220,"hasResults":221,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":33,"eligibilityCriteria":225,"healthyVolunteers":221,"sex":226,"minAge":227,"maxAge":33,"enrollmentInfo":228,"targetDuration":33,"studyType":231,"phases":232,"briefSummary":235,"conditions":236,"keywords":33,"overallStatus":48,"whyStopped":33,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":247},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8,14,18,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Part I - SAR446597 open-label (OL)","EXPERIMENTAL","Participants will receive SAR at a dose specified for each cohort. Multiple dose levels of SAR446597 will be evaluated in successive cohorts of participants.",[13],"Drug: SAR446597",{"label":15,"type":10,"description":16,"interventionNames":17},"Part II - SAR446597 Dose A","Participants will receive SAR at a dose specified for each arm.",[13],{"label":19,"type":10,"description":16,"interventionNames":20},"Part II - SAR446597 Dose B",[13],{"label":22,"type":23,"description":24,"interventionNames":25},"Part II - Sham control","SHAM_COMPARATOR","Participants will receive Sham at a dose specified for each arm.",[26],"Drug: Sham Comparator",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","SAR446597","Intravitreal injection",[9,15,19],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Sham Comparator","Sham injection",[22],[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","option 6","contact-us@sanofi.com",[46,60,69,79,88,98,108,117,127,137,147,153,162,171,176,185,197,207],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":33},"Associated Retina Consultants - Peoria- Site Number : 8400011","RECRUITING","Peoria","Arizona","85381","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-112.23738,33.5806,{"lat":58,"lon":57},{"facility":61,"status":48,"city":62,"state":50,"zip":63,"country":52,"countryCode":53,"cosmosGeoPoint":64,"geoPoint":68,"contacts":33},"Retina Macula Institute of Arizona- Site Number : 8400028","Scottsdale","85255",{"type":55,"coordinates":65},[66,67],-111.89903,33.50921,{"lat":67,"lon":66},{"facility":70,"status":48,"city":71,"state":72,"zip":73,"country":52,"countryCode":53,"cosmosGeoPoint":74,"geoPoint":78,"contacts":33},"Vitreo Retinal Associates - Gainesville- Site Number : 8400004","Gainesville","Florida","32607",{"type":55,"coordinates":75},[76,77],-82.32483,29.65163,{"lat":77,"lon":76},{"facility":80,"status":48,"city":81,"state":72,"zip":82,"country":52,"countryCode":53,"cosmosGeoPoint":83,"geoPoint":87,"contacts":33},"Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002","St. Petersburg","33711",{"type":55,"coordinates":84},[85,86],-82.67927,27.77086,{"lat":86,"lon":85},{"facility":89,"status":48,"city":90,"state":91,"zip":92,"country":52,"countryCode":53,"cosmosGeoPoint":93,"geoPoint":97,"contacts":33},"University Retina - Lemont- Site Number : 8400005","Lemont","Illinois","60439",{"type":55,"coordinates":94},[95,96],-88.00173,41.67364,{"lat":96,"lon":95},{"facility":99,"status":48,"city":100,"state":101,"zip":102,"country":52,"countryCode":53,"cosmosGeoPoint":103,"geoPoint":107,"contacts":33},"The Retina Group of Washington - Chevy Chase- Site Number : 8400009","Chevy Chase","Maryland","20815",{"type":55,"coordinates":104},[105,106],-77.07115,39.00287,{"lat":106,"lon":105},{"facility":109,"status":48,"city":110,"state":101,"zip":111,"country":52,"countryCode":53,"cosmosGeoPoint":112,"geoPoint":116,"contacts":33},"Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003","Hagerstown","21740",{"type":55,"coordinates":113},[114,115],-77.71999,39.64176,{"lat":115,"lon":114},{"facility":118,"status":48,"city":119,"state":120,"zip":121,"country":52,"countryCode":53,"cosmosGeoPoint":122,"geoPoint":126,"contacts":33},"Oregon Retina- Site Number : 8400017","Eugene","Oregon","97401",{"type":55,"coordinates":123},[124,125],-123.08675,44.05207,{"lat":125,"lon":124},{"facility":128,"status":48,"city":129,"state":130,"zip":131,"country":52,"countryCode":53,"cosmosGeoPoint":132,"geoPoint":136,"contacts":33},"Mid Atlantic Retina - Bethlehem- Site Number : 8400031","Bethlehem","Pennsylvania","18017-9412",{"type":55,"coordinates":133},[134,135],-75.37046,40.62593,{"lat":135,"lon":134},{"facility":138,"status":48,"city":139,"state":140,"zip":141,"country":52,"countryCode":53,"cosmosGeoPoint":142,"geoPoint":146,"contacts":33},"Retina Consultants of Austin- Site Number : 8400015","Austin","Texas","78705",{"type":55,"coordinates":143},[144,145],-97.74306,30.26715,{"lat":145,"lon":144},{"facility":148,"status":48,"city":139,"state":140,"zip":149,"country":52,"countryCode":53,"cosmosGeoPoint":150,"geoPoint":152,"contacts":33},"Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007","78750",{"type":55,"coordinates":151},[144,145],{"lat":145,"lon":144},{"facility":154,"status":48,"city":155,"state":140,"zip":156,"country":52,"countryCode":53,"cosmosGeoPoint":157,"geoPoint":161,"contacts":33},"Retina Consultants of Texas - Bellaire- Site Number : 8400019","Bellaire","77401",{"type":55,"coordinates":158},[159,160],-95.45883,29.70579,{"lat":160,"lon":159},{"facility":163,"status":48,"city":164,"state":140,"zip":165,"country":52,"countryCode":53,"cosmosGeoPoint":166,"geoPoint":170,"contacts":33},"Retina Foundation of the Southwest- Site Number : 8400001","Dallas","75231",{"type":55,"coordinates":167},[168,169],-96.80667,32.78306,{"lat":169,"lon":168},{"facility":172,"status":48,"city":164,"state":140,"zip":165,"country":52,"countryCode":53,"cosmosGeoPoint":173,"geoPoint":175,"contacts":33},"Texas Retina Associates - Dallas- Site Number : 8400006",{"type":55,"coordinates":174},[168,169],{"lat":169,"lon":168},{"facility":177,"status":48,"city":178,"state":140,"zip":179,"country":52,"countryCode":53,"cosmosGeoPoint":180,"geoPoint":184,"contacts":33},"Retinal Consultants of Texas - San Antonio- Site Number : 8400012","San Antonio","78240",{"type":55,"coordinates":181},[182,183],-98.49363,29.42412,{"lat":183,"lon":182},{"facility":186,"status":48,"city":187,"state":188,"zip":189,"country":190,"countryCode":191,"cosmosGeoPoint":192,"geoPoint":196,"contacts":33},"Investigational Site Number : 0360003","Sydney","New South Wales","2000","Australia","AU",{"type":55,"coordinates":193},[194,195],151.20732,-33.86785,{"lat":195,"lon":194},{"facility":198,"status":48,"city":199,"state":200,"zip":201,"country":190,"countryCode":191,"cosmosGeoPoint":202,"geoPoint":206,"contacts":33},"Investigational Site Number : 0360002","Adelaide","South Australia","5000",{"type":55,"coordinates":203},[204,205],138.59863,-34.92866,{"lat":205,"lon":204},{"facility":208,"status":48,"city":209,"state":210,"zip":211,"country":190,"countryCode":191,"cosmosGeoPoint":212,"geoPoint":216,"contacts":33},"Investigational Site Number : 0360001","East Melbourne","Victoria","3002",{"type":55,"coordinates":213},[214,215],144.9879,-37.81667,{"lat":215,"lon":214},{"type":218,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100609488","phase-1-a-safety-and-efficacy-study-of-a-one-time-intravitreal-injection-of-sar446597-in-participants-with-geographic-atrophy-secondary-to-age-related-macular-degeneration-100609488",false,"NCT07215234","A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration","A Phase 1\u002F2, Study to Evaluate the Safety, Tolerability, and Efficacy of One-time Intravitreal Dose of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration","Inclusion Criteria:\n\n* 60 years old or above\n* Participants with diagnosis of GA secondary to age-related macular degeneration (AMD)\n* Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20\u002F40 and 20\u002F320 and for expansion (Part II) equal or better than 20\u002F200\n* Study eye with GA lesion measuring between 2.5 and 17.5 mm2 for dose escalation (Part I) and between 2.5 and 14.0 mm2 for expansion (Part II). For multifocal disease, study eye with at least one single lesion of more than 1.25mm2 for both Part I and Part II\n\nExclusion Criteria:\n\n* GA in the study eye caused by a disease different than AMD\n* Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye\n* Any condition or treatment (ocular or systemic) or medical or surgical history in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments\n* Current or history of systemic complement targeting treatment in the past 12 months\n* Use of ocular corticosteroids for 4 months (for ocular or periocular injections), 6 months (for intraocular implants) or 3 years (for long lasting intraocular implants) prior to screening in the study eye\n* History of macular laser photocoagulation treatment, photodynamic- or thermotherapy or photo biomodulation in the study eye\n* History of active ocular infection in the study eye in 6 months prior to screening\n* Presence of active ocular or periocular infections\n* Active uncontrolled glaucoma in the study eye\n* History of uveitis or scleritis in either eye\n* Previous gene therapy in either eye\n* Any significant poorly controlled illness that would preclude study compliance and follow up\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","ALL","60 Years",{"count":229,"type":230},104,"ESTIMATED","INTERVENTIONAL",[233,234],"PHASE1","PHASE2","This is a sequential Phase 1\u002F2, two-part, multicenter study on safety, tolerability, and efficacy of one-time intravitreal SAR446597 for the treatment of participants with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD).\n\nThe core phase duration will be approximately 2 years for each participant. An Extended Follow-Up (EFU) phase of 3 years follows the core phase.\n\nThe treatment is a one-time intravitreal injection of SAR446597 (or sham as applicable in Part II).",[237],"Geographic Atrophy","2026-06-30",{"date":240,"type":241},"2026-07-01","ACTUAL",{"date":243,"type":241},"2025-10-09",{"date":245,"type":230},"2032-07-22",{"name":5,"class":6},18]