[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05210803":3,"trial-entities:NCT05210803":194,"trial-summary:NCT05210803":198},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":26,"primary_purpose":17,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":56,"minimum_age":17,"maximum_age":17,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":62,"locations":66,"central_contacts":190,"overall_officials":191,"references":192,"see_also_links":193},"NCT05210803","RGX-314-5102","Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD","A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Participants With Neovascular Age-Related Macular Degeneration","ENROLLING_BY_INVITATION","2028-03","2025-06","2025-06-18","2021-12-20","AbbVie","INDUSTRY",true,"This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study of nAMD in which they received suprachoroidal space (SCS) administration of RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for up to 5 years after RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following RGX-314 administration in the parent study.",null,[19,20,21,22,23,24],"Neovascular Age-Related Macular Degeneration (nAMD)","Gene Therapy","AMD","Wet AMD","wAMD","nAMD",[],"OBSERVATIONAL",[],{"count":29,"type":30},115,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"OTHER","No intervention.","All subjects that previously received RGX-314 in a parent study",[37],"Roll over",[39],{"measure":40,"description":41,"timeFrame":42},"To evaluate the long-term safety of RGX-314","Incidences of ocular Adverse Events and Serious Adverse Events, and all Adverse Events of Special Interest","5 years inclusive of parent study",[44,47,50,53],{"measure":45,"description":46,"timeFrame":42},"• To evaluate the persistence of effect of RGX-314 on best corrected visual acuity (BCVA)","• Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in BCVA",{"measure":48,"description":49,"timeFrame":42},"• To evaluate the persistence of effect of RGX-314 on central retinal thickness (CRT), as measured by spectral domain-optical coherence tomography (SD-OCT)","• Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in CRT as measured by SD-OCT",{"measure":51,"description":52,"timeFrame":42},"• To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy","• Mean number of supplemental anti-VEGF injections based on chart review",{"measure":54,"description":55,"timeFrame":42},"• To assess the need of clinic visits for management of nAMD","• Mean number of retina specialist visits attended for nAMD based on chart review","ALL",false,{"inclusion":59,"exclusion":60,"raw_text":61},[],[],"Inclusion Criteria:\n\n1. Must provide written, signed informed consent for this study.\n2. Must have been enrolled in a previous clinical study of RGX-314 in the treatment of nAMD and must have received an SCS injection of RGX-314 in that study.\n3. Must be willing and able to comply with all study procedures.\n\nExclusion Criteria:\n\n1\\. None",[63,64,65],"CHILD","ADULT","OLDER_ADULT",[67,76,84,91,98,105,111,119,127,135,143,151,159,167,175,182],{"facility":68,"city":69,"state":70,"zip":71,"country":72,"geoPoint":73},"Retinal Research Institute, LLC","Phoenix","Arizona","85014","United States",{"lat":74,"lon":75},33.44838,-112.07404,{"facility":77,"city":78,"state":79,"zip":80,"country":72,"geoPoint":81},"California Retina Consultants","Bakersfield","California","93309",{"lat":82,"lon":83},35.37329,-119.01871,{"facility":85,"city":86,"state":79,"zip":87,"country":72,"geoPoint":88},"Retina-Vitreous Associates Medical Group","Beverly Hills","90211",{"lat":89,"lon":90},34.07362,-118.40036,{"facility":92,"city":93,"state":79,"zip":94,"country":72,"geoPoint":95},"Northern California Retina Vitreous Associates Medical Group Inc","Mountain View","94040",{"lat":96,"lon":97},37.38605,-122.08385,{"facility":99,"city":100,"state":79,"zip":101,"country":72,"geoPoint":102},"Retina Consultants San Diego","Poway","92064",{"lat":103,"lon":104},32.96282,-117.03586,{"facility":77,"city":106,"state":79,"zip":107,"country":72,"geoPoint":108},"Santa Barbara","93103",{"lat":109,"lon":110},34.42083,-119.69819,{"facility":112,"city":113,"state":114,"zip":115,"country":72,"geoPoint":116},"Southeast Retina Center PC","Augusta","Georgia","30909",{"lat":117,"lon":118},33.47097,-81.97484,{"facility":120,"city":121,"state":122,"zip":123,"country":72,"geoPoint":124},"Johns Hopkins University","Baltimore","Maryland","21205",{"lat":125,"lon":126},39.29038,-76.61219,{"facility":128,"city":129,"state":130,"zip":131,"country":72,"geoPoint":132},"Ophthalmic Consultants of Boston","Boston","Massachusetts","02114",{"lat":133,"lon":134},42.35843,-71.05977,{"facility":136,"city":137,"state":138,"zip":139,"country":72,"geoPoint":140},"Vitreoretinal Surgery PLLC","Edina","Minnesota","55435",{"lat":141,"lon":142},44.88969,-93.34995,{"facility":144,"city":145,"state":146,"zip":147,"country":72,"geoPoint":148},"Sierra eye Associates","Reno","Nevada","89502",{"lat":149,"lon":150},39.52963,-119.8138,{"facility":152,"city":153,"state":154,"zip":155,"country":72,"geoPoint":156},"Vision Research Center Eye Associates of New Mexico","Albuquerque","New Mexico","87109",{"lat":157,"lon":158},35.08449,-106.65114,{"facility":160,"city":161,"state":162,"zip":163,"country":72,"geoPoint":164},"Retinovitreous Associates, LTD","Philadelphia","Pennsylvania","19107",{"lat":165,"lon":166},39.95238,-75.16362,{"facility":168,"city":169,"state":170,"zip":171,"country":72,"geoPoint":172},"Charles Retina Institute, P.C","Germantown","Tennessee","38138",{"lat":173,"lon":174},35.08676,-89.81009,{"facility":176,"city":177,"state":170,"zip":178,"country":72,"geoPoint":179},"Tennessee Retina, PC","Nashville","37203",{"lat":180,"lon":181},36.16589,-86.78444,{"facility":183,"city":184,"state":185,"zip":186,"country":72,"geoPoint":187},"Retina Consultants of Texas","The Woodlands","Texas","77384",{"lat":188,"lon":189},30.15799,-95.48938,[],[],[],[],{"nct_id":4,"conditions":195,"biomarkers":197},[196],"Exudative age-related macular degeneration",[],{"nct_id":4,"found":57,"summary":17,"prompt_version":17}]