[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625660":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":34,"centralContacts":38,"locations":46,"responsibleParty":148,"collaborators":29,"id":150,"slug":151,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":29,"eligibilityCriteria":156,"healthyVolunteers":152,"sex":157,"minAge":158,"maxAge":29,"enrollmentInfo":159,"targetDuration":29,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":29,"overallStatus":49,"whyStopped":29,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Genentech, Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Multiple Ascending Dose (MAD) Monotherapy","EXPERIMENTAL","Participants will receive multiple doses of RO7823653, administered as an IVT injection.",[13],"Drug: RO7823653",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 2: Optional Multiple-Dose Expansion","Participants will receive multiple doses of RO7823653 administered as an IVT injection, at or below the maximum tolerated dose (MTD) or maximum tested dose (MTeD), as determined during the MAD stage.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part 3: MAD (RO7823653 + Faricimab)","Participants will receive multiple doses of RO7823653 along with faricimab, administered as an IVT injection.",[13,22],"Drug: Faricimab",[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","RO7823653","Participants will receive RO7823653 as an IVT injection per the schedule described in the protocol.",[9,15,19],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Faricimab","Participants will receive faricimab as an IVT injection per the schedule described in the protocol.",[19],[35],{"name":36,"affiliation":5,"role":37},"Clinical Trials","STUDY_DIRECTOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":29,"email":43},"Reference Study ID Number GR46431 https:\u002F\u002Fforpatients.roche.com\u002F","CONTACT","888-662-6728 (U.S. and Canada)","global-roche-genentech-trials@gene.com",{"name":45,"role":41,"phone":29,"phoneExt":29,"email":29},"Fastest response: use the inquiry form. No email attachments. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[47,61,71,80,90,100,110,120,129,138],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":29},"Associated Retina Consultants - Peoria - DocTrials - PPDS","RECRUITING","Peoria","Arizona","85381-3690","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-112.23738,33.5806,{"lat":59,"lon":58},{"facility":62,"status":49,"city":63,"state":64,"zip":65,"country":53,"countryCode":54,"cosmosGeoPoint":66,"geoPoint":70,"contacts":29},"Retina-Vitreous Associates Medical Group","Beverly Hills","California","90211-1838",{"type":56,"coordinates":67},[68,69],-118.40036,34.07362,{"lat":69,"lon":68},{"facility":72,"status":49,"city":73,"state":64,"zip":74,"country":53,"countryCode":54,"cosmosGeoPoint":75,"geoPoint":79,"contacts":29},"Bay Area Retina Specialists Medical Group - Vestrum - PPDS","Walnut Creek","94598-5915",{"type":56,"coordinates":76},[77,78],-122.06496,37.90631,{"lat":78,"lon":77},{"facility":81,"status":49,"city":82,"state":83,"zip":84,"country":53,"countryCode":54,"cosmosGeoPoint":85,"geoPoint":89,"contacts":29},"Retina Vitreous Associates of Florida","St. Petersburg","Florida","33711-1141",{"type":56,"coordinates":86},[87,88],-82.67927,27.77086,{"lat":88,"lon":87},{"facility":91,"status":49,"city":92,"state":93,"zip":94,"country":53,"countryCode":54,"cosmosGeoPoint":95,"geoPoint":99,"contacts":29},"Erie Retina Research, LLC - 300 State St","Erie","Pennsylvania","16507-1429",{"type":56,"coordinates":96},[97,98],-80.08506,42.12922,{"lat":98,"lon":97},{"facility":101,"status":49,"city":102,"state":103,"zip":104,"country":53,"countryCode":54,"cosmosGeoPoint":105,"geoPoint":109,"contacts":29},"Charles Retina Institute","Germantown","Tennessee","38138-2405",{"type":56,"coordinates":106},[107,108],-89.81009,35.08676,{"lat":108,"lon":107},{"facility":111,"status":49,"city":112,"state":113,"zip":114,"country":53,"countryCode":54,"cosmosGeoPoint":115,"geoPoint":119,"contacts":29},"Retina Research Institute of Texas","Abilene","Texas","79606-1224",{"type":56,"coordinates":116},[117,118],-99.73314,32.44874,{"lat":118,"lon":117},{"facility":121,"status":49,"city":122,"state":113,"zip":123,"country":53,"countryCode":54,"cosmosGeoPoint":124,"geoPoint":128,"contacts":29},"Austin Clinical Research, LLC","Austin","78750-2298",{"type":56,"coordinates":125},[126,127],-97.74306,30.26715,{"lat":127,"lon":126},{"facility":130,"status":49,"city":131,"state":113,"zip":132,"country":53,"countryCode":54,"cosmosGeoPoint":133,"geoPoint":137,"contacts":29},"Retina Consultants of Texas Westover Hills Retina Center","San Antonio","78251",{"type":56,"coordinates":134},[135,136],-98.49363,29.42412,{"lat":136,"lon":135},{"facility":139,"status":49,"city":140,"state":141,"zip":142,"country":53,"countryCode":54,"cosmosGeoPoint":143,"geoPoint":147,"contacts":29},"Piedmont Eye Center","Lynchburg","Virginia","24502-4271",{"type":56,"coordinates":144},[145,146],-79.14225,37.41375,{"lat":146,"lon":145},{"type":149,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100625660","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacodynamics-and-pharmacokinetics-of-ro7823653-in-participants-with-diabetic-macular-edema-dme-100625660",false,"NCT07425522","A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)","A Phase I, Multicenter, Open-Label, Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 Administered by Intravitreal Injection as Monotherapy and in Combination With Faricimab in Patients With Diabetic Macular Edema","Inclusion Criteria:\n\n* Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and\u002For American Diabetes Association\n* Glycated hemoglobin (HbA1c) \\\u003C= 12%\n* For study eye: Macular thickening secondary to DME involving the center of the fovea with central subfield thickness (CST) \\>= 325 micrometers (µm) as measured by SD-OCT and BCVA of 65 to 35 letters\n\nExclusion Criteria:\n\n* Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required\n* Uncontrolled blood pressure\n* For Parts 1 and 2: Any history of ocular injection\u002Fimplant therapy (e.g., anti-vascular endothelial growth factor agents (anti-VEGF), anti-VEGF\u002Fanti-angiopoietin-2 (Ang-2 agents), corticosteroids, device implant.\n* For Part 3: History of treatment with any of the following: Aflibercept 2 mg, ranibizumab, bevacizumab, or anti-VEGF biosimilars within 90 days prior to Day 1; Aflibercept 8 mg, brolucizumab, or faricimab within 120 days prior to Day 1; Triamcinolone acetonide (IVT, suprachoroidal, or periocular) within 120 days prior to Day 1; Dexamethasone intravitreal implant within 180 days prior to Day 1; Fluocinolone acetonide (FA) intravitreal implant within 3 years prior to Day 1; Device implant\n* History of uveitis, vitritis (grade trace or above), and\u002For scleritis in either eye\n* Active intraocular inflammation in either eye\n* Any previously documented or current proliferative diabetic retinopathy (PDR) in the study eye","ALL","18 Years",{"count":160,"type":161},93,"ESTIMATED","INTERVENTIONAL",[164],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as monotherapy and co-administered with faricimab.",[167],"Diabetic Macular Edema","2026-06-16",{"date":170,"type":171},"2026-06-18","ACTUAL",{"date":173,"type":171},"2026-04-21",{"date":175,"type":161},"2028-11-17",{"name":5,"class":6},10]