[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658533":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":11,"studyPopulation":11,"armGroups":46,"interventions":62,"overallOfficials":11,"centralContacts":71,"locations":11,"responsibleParty":79,"collaborators":11,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":11,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":11,"enrollmentInfo":90,"targetDuration":11,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":11,"overallStatus":99,"whyStopped":11,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":11},{"fullName":5,"class":6},"Genentech, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":11},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Change of GA Lesion Area in the Study Eye",null,"Baseline up to approximately 48 weeks",{"measure":14,"description":11,"timeFrame":15},"Incidence and Severity of Ocular Adverse Events (AEs)","Up to approximately 72 Weeks",{"measure":17,"description":11,"timeFrame":15},"Incidence and Severity of Non-Ocular AEs",[19,21,23,25,27,29,31,33,35],{"measure":10,"description":11,"timeFrame":20},"Baseline up to approximately 72 weeks",{"measure":22,"description":11,"timeFrame":12},"Change from Baseline in Best Correct Visual Acuity (BCVA) Score on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart",{"measure":24,"description":11,"timeFrame":12},"Change from Baseline in BCVA Score on the ETDRS Chart Under Low-luminance Conditions",{"measure":26,"description":11,"timeFrame":15},"Incidence and Severity of Selected Findings in Ocular Examinations and Ocular Imaging",{"measure":28,"description":11,"timeFrame":20},"Plasma Concentration of RO7965032",{"measure":30,"description":11,"timeFrame":20},"Percent Change from Baseline in Levels of Target Protein in Plasma",{"measure":32,"description":11,"timeFrame":20},"Percent Change from Baseline in Levels of Plasma Biomarker Activity",{"measure":34,"description":11,"timeFrame":20},"Prevalence and Incidence of Anti-Drug Antibodies (ADAs)",{"measure":36,"description":11,"timeFrame":15},"Recommended Dose of RO7965032",{"allocation":38,"interventionModel":39,"interventionModelDescription":11,"primaryPurpose":40,"observationalModel":11,"timePerspective":11,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":11,"whoMasked":43},"DOUBLE",[44,45],"PARTICIPANT","INVESTIGATOR",[47,53,56],{"label":48,"type":49,"description":50,"interventionNames":51},"RO7965032 Dose Level 1","EXPERIMENTAL","Participants will receive RO7965032.",[52],"Drug: RO7965032",{"label":54,"type":49,"description":50,"interventionNames":55},"RO7965032 Dose Level 2",[52],{"label":57,"type":58,"description":59,"interventionNames":60},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo.",[61],"Drug: Placebo",[63,68],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":11},"DRUG","RO7965032","RO7965032 will be administered as per the schedule defined in the protocol.",[48,54],{"type":64,"name":57,"description":69,"armGroupLabels":70,"otherNames":11},"Placebo will be administered as per the schedule defined in the protocol.",[57],[72,77],{"name":73,"role":74,"phone":75,"phoneExt":11,"email":76},"Reference Study ID Number: XR46785 https:\u002F\u002Fforpatients.roche.com\u002FNo attachments to email below.","CONTACT","888-662-6728 (U.S. and Canada)","global-roche-genentech-trials@gene.com",{"name":78,"role":74,"phone":11,"phoneExt":11,"email":11},"Fastest Response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",{"type":80,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100658533","phase-2-a-study-to-assess-the-efficacy-and-safety-of-ro7965032-in-participants-with-geographic-atrophy-secondary-to-age-related-macular-degeneration-100658533",false,"NCT07851259","A Study to Assess the Efficacy and Safety of RO7965032 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration","A Phase II, Randomized, Double-Masked, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of RO7965032 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration","Inclusion Criteria:\n\nOcular Inclusion Criteria for the Study Eye\n\n* BCVA score of \\>= 35 letters using the ETDRS VA chart at a starting distance of 4 meters\n* Lesions may be either extrafoveal or subfoveal\n\nOcular Inclusion Criteria for Both Eyes\n\n* Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging\n* Well-demarcated GA secondary to AMD\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria - History of hypersensitivity, a severe allergic reaction or anaphylactic reaction to any component of the investigational drug injection\n\nOcular Exclusion Criteria for the Study Eye\n\n* History of diabetic macular edema (DME), retinal vein occlusion, corneal transplant, retinal detachment, Stage 3 or 4 macular hole, optic neuropathy, or retinal dystrophy\n* Current or prior history of central serous retinopathy\n* Aphakia or absence of the posterior capsule in the study eye\n\nOcular Exclusion Criteria for the Non-Study Eye\n\n\\- Non-functioning non-study eye defined as either BCVA of hand motion or worse or no physical presence of non-study eye (i.e., monocular)\n\nOcular Exclusion Criteria for Either Eye\n\n* Proliferative diabetic retinopathy\n* History of recurrent infectious or inflammatory ocular disease\n* Current or prior history of choroidal neovascularization (CNV) in either eye\n* Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply","ALL","50 Years",{"count":91,"type":92},321,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","This study will assess the safety and efficacy of RO7965032 to address a significant unmet medical need in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD)",[98],"Geographic Atrophy Secondary to Age-Related Macular Degeneration","NOT_YET_RECRUITING","2026-09-25",{"date":102,"type":103},"2026-10-01","ACTUAL",{"date":105,"type":92},"2026-09-30",{"date":107,"type":92},"2030-08-21",{"name":5,"class":6}]