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A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema

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研究单位: [1]Hoffmann-La Roche [2]Retinal Research Institute, LLC,Phoenix,Arizona,United States,85014 [3]Associated Retina Consultants,Phoenix,Arizona,United States,85020 [4]Northwest Arkansas Retina Associates,Springdale,Arkansas,United States,72762 [5]California Retina Consultants,Bakersfield,California,United States,93309 [6]Retina-Vitreous Associates Medical Group,Beverly Hills,California,United States,90211 [7]The Retina Partners,Encino,California,United States,91436 [8]Retina Consultants of Orange County,Fullerton,California,United States,92835 [9]Northern California Retina Vitreous Associates,Mountain View,California,United States,94040 [10]Retinal Consultants Med Group,Sacramento,California,United States,95825 [11]California Retina Consultants,Santa Barbara,California,United States,93103 [12]Bay Area Retina Associates,Walnut Creek,California,United States,94598 [13]University of Colorado [14]dept of ophthalmology,Aurora,Colorado,United States,80045 [15]Retina Consultants of Southern,Colorado Springs,Colorado,United States,80909 [16]Retina Group of New England,Waterford,Connecticut,United States,06385 [17]Retina Group of Florida,Fort Lauderdale,Florida,United States,33308 [18]National Ophthalmic Research Institute,Fort Myers,Florida,United States,33912 [19]Florida Eye Associates,Melbourne,Florida,United States,32901 [20]Sunderland Eye Infirmary,Sunderland,United Kingdom,SR2 9HP [21]Bascom Palmer Eye Institute,Palm Beach Gardens,Florida,United States,33418 [22]Fort Lauderdale Eye Institute,Plantation,Florida,United States,33324 [23]Retina Vitreous Assoc of FL,Saint Petersburg,Florida,United States,33711 [24]Southeast Retina Center,Augusta,Georgia,United States,30909 [25]University Retina and Macula Associates, PC,Lemont,Illinois,United States,60439 [26]Prairie Retina Center,Springfield,Illinois,United States,62704 [27]Retina Specialists,Towson,Maryland,United States,21204 [28]Tufts Medical Center [29]Ophthalmology,Boston,Massachusetts,United States,02111 [30]Associated Retinal Consultants,Grand Rapids,Michigan,United States,49546 [31]Vitreo-Retinal Associates,Grand Rapids,Michigan,United States,49546 [32]Retina Consultants of Nevada,Las Vegas,Nevada,United States,89123 [33]Envision Ocular, LLC,Bloomfield,New Jersey,United States,07003 [34]Mid Atlantic Retina - Wills Eye Hospital,Cherry Hill,New Jersey,United States,08034 [35]Long Is. Vitreoretinal Consult,Great Neck,New York,United States,11021 [36]New York University,New York,New York,United States,10017 [37]Ophthalmic Cons of Long Island,Oceanside,New York,United States,11572 [38]Retina Assoc of Western NY,Rochester,New York,United States,14620 [39]University of Rochester Flaum Eye Institute,Rochester,New York,United States,14642 [40]The Retina Consultants,Slingerlands,New York,United States,12159 [41]Cleveland Clinic Foundation [42]Cole Eye Institute,Cleveland,Ohio,United States,44195 [43]Palmetto Retina Center,Florence,South Carolina,United States,29501 [44]Retina Consultants Of Carolina,Greenville,South Carolina,United States,29605 [45]Charleston Neuroscience Inst,Ladson,South Carolina,United States,29456 [46]Southeastern Retina Associates Chattanooga,Chattanooga,Tennessee,United States,37421 [47]Southeastern Retina Associates,Knoxville,Tennessee,United States,37923 [48]Tennessee Retina PC,Nashville,Tennessee,United States,37203 [49]Austin Retina Associates,Austin,Texas,United States,78705 [50]Retina Consultants of Texas,Bellaire,Texas,United States,77401 [51]Retina Center of Texas,Southlake,Texas,United States,76092 [52]Univ of Virginia Ophthalmology,Charlottesville,Virginia,United States,22903 [53]Retina Institute of Virginia,Richmond,Virginia,United States,23235 [54]Retina Center Northwest,Silverdale,Washington,United States,98383 [55]Organizacion Medica de Investigacion,Buenos Aires,Argentina,C1015ABO [56]Fundacion Zambrano,Caba,Argentina,C1017AAO [57]Oftalmos,Capital Federal,Argentina,C1120AAN [58]Oftar,Mendoza,Argentina,M5500GGK [59]Centro Oftalmólogos Especialistas,Rosario,Argentina,S2000ANJ [60]Grupo Laser Vision,Rosario,Argentina,S2000DLA [61]Strathfield Retina Clinic,Strathfield,New South Wales,Australia,2135 [62]Sydney Eye Hospital,Sydney,New South Wales,Australia,2000 [63]Sydney Retina Clinic and Day Surgery,Sydney,New South Wales,Australia,2000 [64]Sydney West Retina,Westmead,New South Wales,Australia,2145 [65]Centre For Eye Research Australia,East Melbourne,Victoria,Australia,3002 [66]Retina Specialists Victoria,Rowville,Victoria,Australia,3178 [67]The Lions Eye Institute,Nedlands,Western Australia,Australia,6009 [68]Hospital de Olhos de Aparecida - HOA,Aparecida de Goiania,GO,Brazil,74980-010 [69]Centro Brasileiro de Cirurgia,Goiania,GO,Brazil,74210-010 [70]Hospital das Clinicas - UFRGS,Porto Alegre,RS,Brazil,90035-903 [71]Botelho Hospital da Visao,Blumenau,SC,Brazil,89052-504 [72]Faculdade de Medicina do ABC - FMABC,Santo Andre,SP,Brazil,09060-650 [73]Universidade Federal de Sao Paulo - UNIFESP*X [74]Oftalmologia,Sao Paulo,SP,Brazil,04023-062 [75]CEMAPE - Centro Médico,Sao Paulo,SP,Brazil,04084-002 [76]Hospital das Clinicas - FMUSP,Sao Paulo,SP,Brazil,05403-900 [77]Hosp de Olhos de Sorocaba,Sorocaba,SP,Brazil,18031-060 [78]Calgary Retina Consultants,Calgary,Alberta,Canada,T2J 0C8 [79]University of British Columbia - Vancouver Coastal Health Authority,Vancouver,British Columbia,Canada,V5Z 1M9 [80]QEII - HSC Department of Ophthalmology,Halifax,Nova Scotia,Canada,B3H 2Y9 [81]Vitreous Retina Macula Specialists of Toronto,Etobicoke,Ontario,Canada,M8X 2X3 [82]Ivey Eye Institute,London,Ontario,Canada,N6A 4V2 [83]University of Ottawa Eye Institute,Ottawa,Ontario,Canada,K1H 8L6 [84]Toronto Retina Institute,Toronto,Ontario,Canada,M3C 0G9 [85]Unity Health Toronto,Toronto,Ontario,Canada,M5B IW8 [86]University Health Network Toronto Western Hospital,Toronto,Ontario,Canada,M5T 2S9 [87]Institut De L'Oeil Des Laurentides,Boisbriand,Quebec,Canada,J7H 0E8 [88]Hôpital Maisonneuve - Rosemont,Montreal,Quebec,Canada,H1T 2M4 [89]Peking Union Medical College Hospital,Beijing City,China,100032 [90]Beijing Friendship Hospital,Beijing,China,100050 [91]Beijing Tongren Hospital,Beijing,China,100730 [92]The Second Hospital of Jilin University,Changchun,China,130041 [93]West China Hospital, Sichuan University,Chengdu,China,610041 [94]Southwest Hospital , Third Military Medical University [95]Ophthalmology,Chongqing City,China,400014 [96]Third Affiliated Hospital of Third Military Medical University [97]Ophthalmology,ChongQing,China,400000 [98]Zhongshan Ophthalmic Center, Sun Yat-sen University,Guangzhou City,China,510060 [99]The Affiliated Eye Hospital of Nanjing Medical University,Nanjing City,China,210029 [100]Shanghai Tenth People's Hospital,Shanghai,China,200072 [101]Shanghai First People's Hospital,Shanghai,China,200080 [102]Tianjin Eye Hospital,Tianjin City,China,300050 [103]Tianjin Medical University Eye Hospital,Tianjin City,China,300070 [104]Eye Hospital, Wenzhou Medical University,Wenzhou City,China,325027 [105]Wuxi No.2 People's Hospital,Wuxi,China,214000 [106]FN Hradec Králové, Oční klinika [107]Ophthalmology clinic,Hradec Králové,Czechia,500 05 [108]Faculty Hospital Ostrava [109]Ophthalmology clinic,Ostrava,Czechia,708 52 [110]Faculty Hospital Kralovske Vinohrady [111]Ophthalmology clinic,Prague,Czechia,100 34 [112]AXON Clinical,Prague,Czechia [113]Nemocnice Sokolov,Sokolov,Czechia,356 01 [114]Aalborg Universitetshospital [115]Øjenafdelingen,Aalborg,Denmark,9000 [116]Rigshospitalet Glostrup [117]Afdeling for Øjensygdomme, Center for Forskning,Glostrup,Denmark,2600 [118]Sjællands Universitetshospital, Roskilde [119]Øjenafdelingen,Roskilde,Denmark,4000 [120]Chi De Creteil [121]Ophtalmologie,Creteil,France,94010 [122]CHU Bocage [123]Ophtalmologie,Dijon,France,21079 [124]Hopital de la croix rousse [125]Ophtalmologie,Lyon cedex,France,69317 [126]CHNO des Quinze Vingts [127]Ophtalmologie,Paris,France,75012 [128]Centre Ophtalmologique [129]Imagerie et laser,Paris,France,75015 [130]Centres Ophtalmologique St Exupéry [131]Ophtalmologie,St Cyr Sur Loire,France,37540 [132]Hôpital PURPAN - CHU TOULOUSE [133]Ophtalmologie,Toulouse,France,31059 [134]Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde,Dresden,Germany,01307 [135]Universitätsklinikum Freiburg, Klinik für Augenheilkunde,Freiburg,Germany,79106 [136]Universitätsklinikum des Saarlandes [137]Klinik für Augenheilkunde,Homburg/Saar,Germany,66424 [138]Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik,Magdeburg,Germany,39120 [139]LMU Klinikum der Universität, Augenklinik,München,Germany,80336 [140]Klinikum rechts der Isar der TU München [141]Augenklinik,München,Germany,81675 [142]Universitätsklinikum Würzburg, Augenklinik und Poliklinik,Würzburg,Germany,97080 [143]Queen Mary Hospital [144]Department of Ophthalmology,Hong Kong,Hong Kong [145]Hong Kong Eye Hospital [146]CUHK Eye Centre,Mongkok,Hong Kong [147]Magyar Honvedseg Egeszsegugyi Kozpont [148]Szemészeti Osztály,Budapest,Hungary,1068 [149]Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR,Budapest,Hungary,1076 [150]Semmelweis Egyetem Szemészeti Vizsgálóhely,Budapest,Hungary,1085 [151]Bajcsy-Zsilinszky Hospital,Budapest,Hungary,1106 [152]Fondazione Ptv Policlinico Tor Vergata Di Roma [153]U.O.S.D. Patologie Renitiche,Roma,Lazio,Italy,00133 [154]ASST FATEBENEFRATELLI SACCO [155]Oculistica (Sacco),Milano,Lombardia,Italy,20157 [156]Azienda Ospedaliero-Universitaria Careggi [157]S.O.D. Oculistica,Firenze,Toscana,Italy,50134 [158]Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello [159]U.O. Oculistica Universitaria,Pisa,Toscana,Italy,56124 [160]Ospedale Classificato Equiparato Sacro Cuore - Don Calabria [161]Dipartimento Oculistica,Negrar - Verona,Veneto,Italy,37024 [162]A.O. Universitaria S. Maria Della Misericordia Di Udine [163]Clinica Oculistica,Udine,Veneto,Italy,33100 [164]Seoul National University Bundang Hospital,Seongnam-si,Korea, Republic of,13605 [165]Kyung Hee University Hospital,Seoul,Korea, Republic of,02447 [166]Seoul National University Hospital,Seoul,Korea, Republic of,03080 [167]Samsung Medical Center,Seoul,Korea, Republic of,06351 [168]Asan Medical Center.,Seoul,Korea, Republic of,138-736 [169]OFTALMIKA Sp. Z o.o,Bydgoszcz,Poland,85-631 [170]Specjalistyczny Ośrodek Okulistyczny Oculomedica,Bydgoszcz,Poland,85-870 [171]Optimum Profesorskie Centrum Okulistyki,Gdańsk,Poland,80-809 [172]Poradnia Okulistyczna I Salon Optyczny w Gliwicach- PRYZMAT,Gliwice,Poland,44-100 [173]SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki I Onkologii Okulistycznej,Krakow,Poland,31-501 [174]Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow,Rzeszów,Poland,35-017 [175]Caminomed,Tarnowskie Góry,Poland,42-600 [176]Centrum Zdrowia MDM,Warszawa,Poland,00-631 [177]Hospital de Braga [178]Servico de Oftalmologia,Braga,Portugal,4710-243 [179]AIBILI - Association for Innovation and Biomedical Research on Light,Coimbra,Portugal,3000-548 [180]Espaco Medico Coimbra,Coimbra,Portugal,3030-163 [181]Hospital de Santa Maria [182]Servico de Oftalmologia,Lisboa,Portugal,1649-035 [183]Intersec Research and Technology Complex "Eye Microsurgery" n.a. S.N. Fyodorov [184]Cheboksary Branch,Cheboksary,Marij EL,Russian Federation,428000 [185]Clinics of Eye Diseases, LLC,Kazan,Tatarstan,Russian Federation,420066 [186]"Intersec. Research and Technology Complex "Eye Microsurgery" n a Fyodorov Irkutsk branch,Irkutsk,Russian Federation,664033 [187]"Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch,Novosibirsk,Russian Federation,630096 [188]National University Hospital [189]Ophthalmology Department,Singapore,Singapore,119074 [190]Singapore Eye Research Institute,Singapore,Singapore,168751 [191]Tan Tock Seng Hospital [192]Ophthalmology Department,Singapore,Singapore,308433 [193]Instituto Oftalmologico Fernandez Vega [194]Servicio de oftalmologia,Oviedo,Asturias,Spain,33012 [195]Hospital Universitario de Bellvitge,Hospitalet de Llobregat,Barcelona,Spain,08907 [196]Hospital General de Catalunya,San Cugat Del Valles,Barcelona,Spain,08195 [197]Complejo Hospitalario de Navarra [198]Servicio de oftalmologia,Pamplona,Navarra,Spain,31008 [199]Oftalvist Valencia,Burjassot,Valencia,Spain,46100 [200]Institut de la Macula I la retina,Barcelona,Spain,08022 [201]Hospital dos de maig [202]Pharmacy Service,Barcelona,Spain,08025 [203]Hospital Clinico San Carlos [204]Servicio de oftalmologia,Madrid,Spain,28040 [205]Clinica Baviera [206]Servicio Oftalmologia,Madrid,Spain,28046 [207]Fisabio-Ofalmologia Medica [208]Servicio de Oftalmología,Valencia,Spain,46015 [209]Hospital Universitario Rio Hortega [210]Servicio de Oftalmologia,Valladolid,Spain,47012 [211]Vista Klinik Ophthalmologische Klinik,Binningen,Switzerland,4102 [212]Taipei Veterans General Hospital [213]Ophthalmology,Taipei,Taiwan,11217 [214]Chang Gung Medical Foundation - Linkou [215]Ophthalmology,Taoyuan,Taiwan,333 [216]National Taiwan University Hospital [217]Ophthalmology,Zhongzheng Dist.,Taiwan,10002 [218]King Chulalongkorn Memorial Hospital [219]Ophthalmology Department,Bangkok,Thailand,10330 [220]Rajavithi Hospital [221]Ophthalmology Department,Bangkok,Thailand,10400 [222]Maharaj Nakorn ChiangMai Hospital [223]Ophthalmology Department,ChiangMai,Thailand,50200 [224]Ankara University Medical Faculty [225]Department of Ophthalmology,Ankara,Turkey,06340 [226]Ankara Baskent University Medical Faculty [227]Department of Ophthalmology,Ankara,Turkey,06490 [228]Beyoglu Goz Training and Research Hospital [229]Department Of Ophthalmology,Istanbul,Turkey,34421 [230]Kocaeli Üniversitesi Tıp Fakültesi [231]Department of Ophthalmology,Kocaeli,Turkey,41380 [232]Barnet Hospital [233]ROYAL FREE LONDON NHS FOUNDATION TRUST,Barnet,United Kingdom,EN5 3DJ [234]Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL,Belfast,United Kingdom,BT12 6BA [235]Bradford Royal Infirmary,Bradford,United Kingdom,BD9 6RJ [236]University Hospitals Bristol NHS Foundation Trust, Bristol Eye Hospital,Bristol,United Kingdom,BS1 2LX [237]East Kent Hospitals University NHS Foundation Trust,Canterbury,United Kingdom,CT1 3NG [238]Frimley Park Hospital,Frimley,United Kingdom,GU16 7UJ [239]Gloucestershire Hospitals NHS Foundation Trust,Gloucestershire,United Kingdom,GL1 3NN [240]St James University Hospital,Leeds,United Kingdom,LS9 7TF [241]Royal Liverpool University Hospital [242]St Paul's Clinical Eye Research Centre,Liverpool,United Kingdom,L7 8XP [243]Moorfields Eye Hospital NHS Foundation Trust,London,United Kingdom,EC1V 2PD [244]Royal Free Hospital,London,United Kingdom,NW3 2QS [245]Kings College Hospital,London,United Kingdom,SW9 8RR [246]Manchester Royal Eye Hospital,Manchester,United Kingdom,M13 9WL [247]Hillingdon Hospital,Middx,United Kingdom,UB8 3NN [248]Royal Victoria Infirmary,Newcastle upon Tyne,United Kingdom,NE1 4LP [249]James Paget University Hospitals NHS Foundation Trust,Norfolk,United Kingdom,NR31 6LA [250]University Hospital Southampton NHS Foundation Trust [251]Southampton Eye Unit,Southampton,United Kingdom,SO16 6YD

研究目的:
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

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