[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03167203":3,"trial-entities:NCT03167203":102,"trial-summary:NCT03167203":106},{"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":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":27,"interventions":30,"primary_outcomes":39,"secondary_outcomes":65,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":15,"eligibility_criteria":69,"std_ages":75,"locations":78,"central_contacts":95,"overall_officials":96,"references":100,"see_also_links":101},"NCT03167203","7316-CL-0007","A Safety Surveillance Study in Subjects With Macular Degenerative Disease Treated With Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy","A Safety Surveillance Study of Events of Special Interest Occurring in Subjects With Macular Degenerative Disease Treated With Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy","ENROLLING_BY_INVITATION","2029-03-31","2026-07","2026-07-13","2018-01-08","Astellas Institute for Regenerative Medicine","INDUSTRY",false,"The purpose of this study is to is to evaluate the occurrence of late onset (i.e., greater than 5 years after treatment) adverse events of special interest (AESI) in participants who have received sub-retinal transplant of human embryonic stem cell derived - retinal pigment epithelial (hESC-RPE) cells in an AIRM-sponsored clinical trial. The events of special interest are adverse events (AEs) that are presumed to have a potential causal relationship to the hESC-RPE cells.","Participants will be contacted by the Patient Outreach Center (POC) on an annual basis to complete a questionnaire about the occurrence of AESI, as defined in the Outcome Measure section.\n\nThe questionnaire will be completed directly by the participant (via a secure web based platform) or will be administered via telephone by a POC staff member. In the event of the occurrence of a AESI, study participant will be encouraged to contact the POC as soon as possible, rather than wait for the annual questionnaire completion. Follow up data is inclusive of the 1 year in the core trial, 4 years in the long term follow up trial and 10 years in this long term safety follow up. Participation for United Kingdom participants will be life-long.",[19],"Macular Degenerative Disease",[21,19],"hESC-RPE","INTERVENTIONAL","TREATMENT",[25,26],"PHASE1","PHASE2",{"count":28,"type":29},36,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"BIOLOGICAL","Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells","Participants who have received sub-retinal transplant of hESC-RPE cells in an AIRM sponsored clinical trial",[36],"hESC-RPE cells",[38],"ASP7316",[40,44,47,50,53,56,59,62],{"measure":41,"description":42,"timeFrame":43},"Number of adverse events (AEs) that are ophthalmologic, neurologic, infectious or hematologic","Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA). Participant self-reported via an annual questionnaire of adverse events that are ophthalmologic, neurologic, infectious or hematologic.","Up to 15 Years",{"measure":45,"description":46,"timeFrame":43},"Number of new diagnoses of an immune-mediated disorder","Any new diagnosis of an immune-mediated disorder will be participant self-reported via an annual questionnaire.",{"measure":48,"description":49,"timeFrame":43},"Incidents of new cancer, irrespective of prior history","Any new cancer, irrespective of prior history, will be participant self-reported via an annual questionnaire.",{"measure":51,"description":52,"timeFrame":43},"Incidents of hESC-RPE cell proliferation","Occurrence of human embryonic stem cell derived - retinal pigment epithelial (hESC-RPE) cell proliferation will be participant self-reported via an annual questionnaire.",{"measure":54,"description":55,"timeFrame":43},"Incidents of ectopic tissue (RPE or non-RPE) formation","Occurrence of ectopic tissue (retinal pigment epithelial \\[RPE\\] or non-RPE) will be participant self-reported via an annual questionnaire",{"measure":57,"description":58,"timeFrame":43},"Number of participant reported pregnancies or pregnancy of participant's partner","Occurrence of pregnancy will be participant self-reported via an annual questionnaire",{"measure":60,"description":61,"timeFrame":43},"Number of reported pregnancy outcome(s)","Occurrence of pregnancy outcomes will be participant self-reported via an annual questionnaire",{"measure":63,"description":64,"timeFrame":43},"All cause death","All causes of death will be collected via an annual questionnaire (through participant-designated secondary contacts)",[],"ALL","18 Years",null,{"inclusion":70,"exclusion":73,"raw_text":74},[71,72],"Participant was treated with hESC-RPE cell therapy in an Astellas Institute for Regenerative Medicine (AIRM) sponsored clinical trial in macular degenerative disease.","Participant is able to understand.",[],"Inclusion Criteria:\n\n* Participant was treated with hESC-RPE cell therapy in an Astellas Institute for Regenerative Medicine (AIRM) sponsored clinical trial in macular degenerative disease.\n* Participant is able to understand.\n\nExclusion Criteria:\n\n* There are no exclusion criteria.",[76,77],"ADULT","OLDER_ADULT",[79,88],{"facility":80,"city":81,"state":82,"zip":83,"country":84,"geoPoint":85},"Private Practice","Kansas City","Missouri","64133","United States",{"lat":86,"lon":87},39.09973,-94.57857,{"facility":89,"city":90,"country":91,"geoPoint":92},"Site GB44001","London","United Kingdom",{"lat":93,"lon":94},51.50853,-0.12574,[],[97],{"name":98,"affiliation":13,"role":99},"Medical Monitor","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":103,"biomarkers":105},[104],"Degenerative liver disease",[],{"nct_id":4,"found":15,"summary":68,"prompt_version":68}]