[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623101":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":37,"locations":42,"responsibleParty":98,"collaborators":36,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":36,"enrollmentInfo":110,"targetDuration":36,"studyType":113,"phases":114,"briefSummary":117,"conditions":118,"keywords":36,"overallStatus":45,"whyStopped":36,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Complement Therapeutics","INDUSTRY",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Low Dose",[13],"Genetic: CTx001",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 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Crosse","Wisconsin","54601",{"type":52,"coordinates":83},[84,85],-91.23958,43.80136,{"lat":85,"lon":84},{"facility":88,"status":45,"city":89,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":97,"contacts":36},"The Retina Clinic London","London","W1G 7LB","United Kingdom","UK",{"type":52,"coordinates":94},[95,96],-0.12574,51.50853,{"lat":96,"lon":95},{"type":99,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100623101","phase-1-an-optimised-ga-interventional-trial-opti-gain-to-test-if-treatment-with-ctx001-is-safe-and-works-for-people-with-geographic-atrophy-ga-100623101",false,"NCT07392255","An Optimised GA Interventional Trial (Opti-GAIN) to Test if Treatment With CTx001 is Safe and Works for People With Geographic Atrophy (GA)","A First in Human Phase 1 \u002F 2 Multi-center Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of CTx001 Administered Via a Single Subretinal Injection in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)","Opti-GAIN","Inclusion Criteria:\n\nMeet protocol-defined age eligibility\n\nHave bilateral geographic atrophy secondary to AMD, confirmed by the Reading Center\n\nMeet baseline lesion size requirements, as assessed by fundus autofluorescence imaging\n\nMeet best-corrected visual acuity and low-luminance visual acuity criteria, as measured by ETDRS charts\n\nMeet retinal sensitivity criteria, as measured by microperimetry\n\nHave sufficient fellow-eye visual function to ensure navigational vision\n\nHave adequate historical SD-OCT imaging available for longitudinal assessment\n\nMeet reproductive status and contraception requirements, where applicable\n\nBe able and willing to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\nMacular atrophy or retinal disease not attributable to AMD\n\nEvidence of current or prior choroidal neovascularization (wet AMD)\n\nPrior intraocular, macular, or retinal surgery or laser treatment that may confound assessments\n\nPrior AMD-directed or intravitreal therapy in the study eye, except permitted supplements\n\nPrior exposure to complement inhibitor therapies\n\nOcular conditions, infections, inflammation, or media opacities that interfere with safety or retinal imaging\n\nUncontrolled glaucoma, diabetic retinopathy, or clinically significant refractive error\n\nAphakia or compromised posterior capsule, except as permitted by protocol\n\nSystemic medical or psychiatric conditions that may increase risk or limit compliance\n\nRecent participation in another interventional clinical study or exposure to investigational therapies\n\nAny condition that, in the investigator's judgment, poses unacceptable risk or precludes safe participation","ALL","55 Years",{"count":111,"type":112},75,"ESTIMATED","INTERVENTIONAL",[115,116],"PHASE1","PHASE2","This is a clinical study to evaluate the safety, tolerability and efficacy of CTx001, administered via a single subretinal injection, for GA (secondary to AMD).\n\nSafety and efficacy will be measured at regular intervals for 2 years after which long-term safety will be assessed annually for up to 5 years.",[119],"Geographic Atrophy Secondary to Age-related Macular Degeneration","2026-06-18",{"date":122,"type":123},"2026-06-22","ACTUAL",{"date":125,"type":123},"2025-12-30",{"date":127,"type":112},"2032-06-30",{"name":5,"class":6},5]