A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema (Rhone-X)

February 13, 2024 updated by: Hoffmann-La Roche

A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Diabetic Macular Edema

This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.

Study Overview

Status

Completed

Conditions

Diabetic Macular Edema

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1479

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Caba, Argentina, C1017AAO
    - Fundacion Zambrano
  - Capital Federal, Argentina, C1120AAN
    - Oftalmos
  - Mendoza, Argentina, M5500GGK
    - Oftar
  - Rosario, Argentina, S2000DLA
    - Grupo Laser Vision
  - Rosario, Argentina, S2000ANJ
    - Centro Oftalmólogos Especialistas
  - San Nicolás, Argentina, C1015ABO
    - Organizacion Medica de Investigacion
Australia
- New South Wales
  - Strathfield, New South Wales, Australia, 2135
    - Strathfield Retina Clinic
  - Sydney, New South Wales, Australia, 2000
    - Sydney Eye Hospital
  - Sydney, New South Wales, Australia, 2000
    - Sydney Retina Clinic and Day Surgery
  - Westmead, New South Wales, Australia, 2145
    - Sydney West Retina
- Victoria
  - East Melbourne, Victoria, Australia, 3002
    - Centre for Eye Research Australia
  - Rowville, Victoria, Australia, 3178
    - Retina Specialists Victoria
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - The Lions Eye Institute
Austria
- - Graz, Austria, 8036
    - LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
  - Linz, Austria, 4021
    - Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
  - Wien, Austria, 1090
    - Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
  - Wien, Austria, 1140
    - Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik
Brazil
- GO
  - Aparecida de Goiania, GO, Brazil, 74980-010
    - Hospital de Olhos de Aparecida - HOA
  - Goiania, GO, Brazil, 74210-010
    - Centro Brasileiro de Cirurgia
- RS
  - Porto Alegre, RS, Brazil, 90035-903
    - Hospital das Clinicas - UFRGS
- SC
  - Blumenau, SC, Brazil, 89052-504
    - Botelho Hospital da Visao
- SP
  - Santo Andre, SP, Brazil, 09060-650
    - Faculdade de Medicina do ABC - FMABC
  - Sao Paulo, SP, Brazil, 04023-062
    - Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
  - Sao Paulo, SP, Brazil, 04084-002
    - CEMAPE - Centro Médico
  - Sao Paulo, SP, Brazil, 05403-010
    - Hospital das Clinicas - FMUSP
  - Sorocaba, SP, Brazil, 18031-060
    - Hosp de Olhos de Sorocaba
Bulgaria
- - Sofia, Bulgaria, 1309
    - Pentagram Eye Hospital (Medical Center "Pentagram")
  - Sofia, Bulgaria, 1784
    - Specialized Hospital For Active Treatment of Eye Diseases Zora
  - Sofia, Bulgaria, 1517
    - Spec. Ophth. Hospital for Active Treatment- Academic Pashev
  - Sofia, Bulgaria, 1303
    - Medical Center for Eye Health ? Focus Ltd
Canada
- Alberta
  - Calgary, Alberta, Canada, T2J 0C8
    - Calgary Retina Consultants
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - QEII - HSC Department of Ophthalmology
- Ontario
  - London, Ontario, Canada, N6A 4V2
    - Ivey Eye Institute
  - Toronto, Ontario, Canada, M3C 0G9
    - Toronto Retina Institute
  - Toronto, Ontario, Canada, M5T 2S9
    - University Health Network Toronto Western Hospital
  - Toronto, Ontario, Canada, M5C 2T2
    - St. Michael's Hospital; Department of Ophthalmology
- Quebec
  - Boisbriand, Quebec, Canada, J7H 0E8
    - Institut de l'Oeil des Laurentides
Czechia
- - Hradec Králové, Czechia, 500 05
    - FN Hradec Králové, O?ní klinika; Ophthalmology clinic
  - Ostrava, Czechia, 708 52
    - Faculty Hospital Ostrava; Ophthalmology clinic
  - Prague, Czechia, 100 34
    - Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic
  - Prague, Czechia
    - AXON Clinical
  - Sokolov, Czechia, 356 01
    - Nemocnice Sokolov
Denmark
- - Aalborg, Denmark, 9000
    - Aalborg Universitetshospital; Øjenafdelingen
  - Roskilde, Denmark, 4000
    - Sjællands Universitetshospital, Roskilde; Øjenafdelingen
France
- - Bordeaux, France, 33076
    - Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin
  - Creteil, France, 94010
    - Chi De Creteil; Ophtalmologie
  - Ecully, France, 69130
    - Pole Vision Val d'Ouest; Ophtalmologie
  - Nantes, France, 44093
    - CHU Nantes - Hôtel Dieu; Ophthalmology
  - Paris, France, 75010
    - Hopital Lariboisiere; Ophtalmologie
  - St Cyr Sur Loire, France, 37540
    - Centres Ophtalmologique St Exupéry; Ophtalmologie
Germany
- - Dresden, Germany, 01307
    - Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde
  - Freiburg, Germany, 79106
    - Universitätsklinikum Freiburg, Klinik für Augenheilkunde
  - Hannover, Germany, 30625
    - Medizinische Hochschule Hannover, Klinik für Augenheilkunde
  - Homburg/Saar, Germany, 66424
    - Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde
  - Magdeburg, Germany, 39120
    - Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik
  - München, Germany, 80336
    - LMU Klinikum der Universität, Augenklinik
  - München, Germany, 81675
    - Klinikum rechts der Isar der TU München; Augenklinik
  - Münster, Germany, 48145
    - Augenabteilung am St. Franziskus-Hospital
  - Münster, Germany, 48149
    - Universitätsklinikum Münster; Augenheilkunde
  - Würzburg, Germany, 97080
    - Universitätsklinikum Würzburg, Augenklinik und Poliklinik
Hong Kong
- - Hong Kong, Hong Kong
    - Queen Mary Hospital; Department of Ophthalmology
  - Mongkok, Hong Kong
    - Hong Kong Eye Hospital; CUHK Eye Centre
Hungary
- - Budapest, Hungary, 1133
    - Budapest Retina Associates Kft.
  - Budapest, Hungary, 1076
    - Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
  - Budapest, Hungary, 1085
    - Semmelweis Egyetem Szemészeti Vizsgálóhely
  - Budapest, Hungary, 1106
    - Bajcsy-Zsilinszky Hospital
  - Budapest, Hungary, 1068
    - Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Szemeszet
  - Debrecen, Hungary, 4032
    - Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
  - Pécs, Hungary, 7621
    - Ganglion Medial Center
  - Szeged, Hungary, 6720
    - Szegedi Tudományegyetem ÁOK; Department of Ophtalmology
  - Szombathely, Hungary, 9700
    - Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET; Intezeti Gyogyszertar
  - Zalaegerszeg, Hungary, 8900
    - Zala Megyei Kórház; SZEMESZET
Israel
- - Haifa, Israel, 3109601
    - Rambam Medical Center; Opthalmology
  - Jerusalem, Israel, 9112001
    - Hadassah MC; Ophtalmology
  - Petach Tikva, Israel, 4941492
    - Rabin MC; Ophtalmology
  - Rehovot, Israel, 7660101
    - Kaplan Medical Center; Ophtalmology
  - Tel Aviv, Israel, 6423906
    - Tel Aviv Sourasky MC; Ophtalmology
Italy
- Lazio
  - Roma, Lazio, Italy, 00198
    - Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
- Liguria
  - Genova, Liguria, Italy, 16132
    - UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA
- Lombardia
  - Milano, Lombardia, Italy, 20100
    - Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
  - Milano, Lombardia, Italy, 20132
    - Irccs Ospedale San Raffaele;U.O. Oculistica
- Toscana
  - Firenze, Toscana, Italy, 50134
    - Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
  - Pisa, Toscana, Italy, 56124
    - Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria
- Umbria
  - Perugia, Umbria, Italy, 06129
    - Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica
- Veneto
  - Negrar - Verona, Veneto, Italy, 37024
    - Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria; Dipartimento Oculistica
Japan
- - Aichi, Japan, 480-1195
    - Aichi Medical University Hospital
  - Aichi, Japan, 460-0008
    - Sugita Eye Hospital
  - Aichi, Japan, 466-8560
    - Nagoya University Hospital
  - Aichi, Japan, 467-8602
    - Nagoya City University Hospital
  - Chiba, Japan, 285-8741
    - Toho University Sakura Medical Center
  - Fukuoka, Japan, 830-0011
    - Kurume University Hospital
  - Fukuoka, Japan, 812-0011
    - Hayashi Eye Hospital
  - Hokkaido, Japan, 060-8648
    - Hokkaido University Hospital
  - Hokkaido, Japan, 078-8510
    - Asahikawa Medical University Hospital
  - Hyogo, Japan, 660-8550
    - Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
  - Ibaraki, Japan, 310-0845
    - Kozawa Eye Hospital and Diabetes Center
  - Kumamoto, Japan, 860-0027
    - Ideta Eye Hospital
  - Kyoto, Japan, 606-8507
    - Kyoto University Hospital
  - Mie, Japan, 514-8507
    - Mie University Hospital
  - Miyazaki, Japan, 889-1692
    - University of Miyazaki Hospital
  - Nara, Japan, 634-8522
    - Nara Medical University Hospital
  - Osaka, Japan, 545-8586
    - Osaka Metropolitan University Hospital
  - Osaka, Japan, 530-8480
    - Kitano Hospital
  - Saitama, Japan, 359-8513
    - National Defense Medical College Hospital
  - Shiga, Japan, 520-2192
    - Shiga University Of Medical Science Hospital
  - Tokyo, Japan, 193-0998
    - Tokyo Medical University Hachioji Medical Center
  - Tokyo, Japan, 181-8611
    - Kyorin University Hospital
  - Tokyo, Japan, 162-0054
    - Tokyo Women's Medical University
Korea, Republic of
- - Seongnam-si, Korea, Republic of, 463-707
    - Seoul National University Bundang Hospital
  - Seoul, Korea, Republic of, 03080
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 05505
    - Asan Medical Center
  - Seoul, Korea, Republic of, 02447
    - Kyung Hee University Hospital
  - Seoul, Korea, Republic of, 06351
    - Samsung Medical Center
Mexico
- Mexico CITY (federal District)
  - Del. Cuauhtemoc, Mexico CITY (federal District), Mexico, 06760
    - Centro Oftalmológico Mira, S.C
  - Mexico, D.F., Mexico CITY (federal District), Mexico, 01120
    - Macula Retina Consultores
  - Mexico, D.F., Mexico CITY (federal District), Mexico, 04030
    - Hospital de la Ceguera APEC
- Queretaro
  - Querétaro, Queretaro, Mexico, 76180
    - Instituto de la retina del Bajio
Peru
- - Lima, Peru, 27
    - Mácula D&T
  - Lima, Peru, 27
    - TG Laser Oftalmica
  - Lima, Peru, Lima 33
    - Oftalmolaser
Poland
- - Bielsko-Biala, Poland, 43-309
    - Szpital sw. Lukasza
  - Bydgoszcz, Poland, 85-631
    - OFTALMIKA Sp. z o.o
  - Bydgoszcz, Poland, 85-870
    - Specjalistyczny O?rodek Okulistyczny Oculomedica
  - Bytom, Poland, 41-902
    - Szpital Specjalistyczny nr 1; Oddzial Okulistyki
  - Gda?sk, Poland, 80-402
    - Dobry Wzrok Sp Z O O
  - Gda?sk, Poland, 80-809
    - Optimum Profesorskie Centrum Okulistyki
  - Gliwice, Poland, 44-100
    - Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
  - Katowice, Poland, 40-594
    - Gabinet Okulistyczny Prof Edward Wylegala
  - Krakow, Poland, 31-070
    - Centrum Medyczne UNO-MED
  - Krakow, Poland, 31-501
    - SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
  - Rybnik, Poland, 44-203
    - Optomed Sp. z o.o.
  - Rzeszów, Poland, 35-017
    - Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow
  - Rzeszów, Poland, 35-055
    - Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina; Klinika Okulistyki
  - Tarnowskie Góry, Poland, 42-600
    - Caminomed
  - Warszawa, Poland, 00-635
    - Centrum Zdrowia MDM
  - Wroclaw, Poland, 53-334
    - SPEKTRUM Osrodek Okulistyki Klinicznej
Portugal
- - Braga, Portugal, 4710-243
    - Hospital de Braga; Servico de Oftalmologia
  - Coimbra, Portugal, 3030-163
    - Espaco Medico Coimbra
  - Coimbra, Portugal, 3000-548
    - AIBILI - Association for Innovation and Biomedical Research on Light
  - Lisboa, Portugal, 1649-035
    - Hospital de Santa Maria; Servico de Oftalmologia
Russian Federation
- - Irkutsk, Russian Federation, 664033
    - ?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch
  - Novosibirsk, Russian Federation, 630096
    - ?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch
- Baskortostan
  - UFA, Baskortostan, Russian Federation, 450059
    - Clinic Optimed
- Marij EL
  - Cheboksary, Marij EL, Russian Federation, 428000
    - Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch
- Moskovskaja Oblast
  - Moscow, Moskovskaja Oblast, Russian Federation, 119435
    - FSBI ?Scientific Research Institute of Eye Diseases? of Russian Academy of medical Sciences
- Sankt Petersburg
  - St.Petersburg, Sankt Petersburg, Russian Federation, 124044
    - Medical Military Academy n.a S.M.Kirov
- Tatarstan
  - Kazan, Tatarstan, Russian Federation, 420066
    - Clinics of Eye Diseases, LLC
Singapore
- - Singapore, Singapore, 168751
    - Singapore Eye Research Institute
  - Singapore, Singapore, 308433
    - Tan Tock Seng Hospital; Ophthalmology Department
  - Singapore, Singapore, 119074
    - National University Hospital; Ophthalmology Department
Slovakia
- - Trebišov, Slovakia, 075 01
    - Nemocnica s poliklinikou Trebišov, a.s.
  - Trencin, Slovakia, 911 71
    - Fakultna nemocnica Trencin Ocna klinika
  - Zilina, Slovakia, 012 07
    - Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
Spain
- - Albacete, Spain, 02006
    - Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia
  - Alicante, Spain, 03016
    - VISSUM Instituto Oftalmológico de Alicante
  - Barcelona, Spain, 08025
    - Hospital dos de maig; servicio de oftalmologia
  - Barcelona, Spain, 08021
    - Centro de Oftalmologia Barraquer; Servicio Oftalmologia
  - Barcelona, Spain, 08028
    - Hospital Clinic de Barcelona; Consultas Externas Oftalmologia
  - Barcelona, Spain, 08041
    - Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia
  - Madrid, Spain, 28046
    - Clinica Baviera; Servicio Oftalmologia
  - Valencia, Spain, 46015
    - Fisabio-Ofalmologia Medica; Servicio de Oftalmología
  - Valladolid, Spain, 47012
    - Hospital Universitario Rio Hortega; Servicio de Oftalmologia
- Asturias
  - Oviedo, Asturias, Spain, 33012
    - Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia
- Barcelona
  - Hospitalet de Llobregat, Barcelona, Spain, 08907
    - Hospital Universitario de Bellvitge
  - San Cugat Del Valles, Barcelona, Spain, 08195
    - Hospital General de Catalunya
- LA Coruña
  - Santiago de Compostela, LA Coruña, Spain, 15706
    - Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia
- LAS Palmas
  - Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
    - Hospital Universitario de Gran Canaria; Servicio de oftalmologia
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Hospital Universitario Puerta de Hierro
- Navarra
  - Pamplona, Navarra, Spain, 31008
    - Clinica Universitaria de Navarra; Servicio de Oftalmologia
  - Pamplona, Navarra, Spain, 31008
    - Complejo Hospitalario de Navarra; Servicio de oftalmologia
- Valencia
  - Burjassot, Valencia, Spain, 46100
    - Oftalvist Valencia
Switzerland
- - Binningen, Switzerland, 4102
    - Vista Klinik Ophthalmologische Klinik
Taiwan
- - Taipei, Taiwan, 11217
    - Taipei Veterans General Hospital; Ophthalmology
  - Taoyuan, Taiwan, 333
    - Chang Gung Medical Foundation - Linkou; Ophthalmology
  - Zhongzheng Dist., Taiwan, 10002
    - National Taiwan University Hospital; Ophthalmology
Thailand
- - Bangkok, Thailand, 10330
    - King Chulalongkorn Memorial Hospital; Ophthalmology Department
  - Bangkok, Thailand, 10400
    - Rajavithi Hospital; Ophthalmology Department
  - ChiangMai, Thailand, 50200
    - Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department
Turkey
- - Ankara, Turkey, 06340
    - Ankara University Medical Faculty; Department of Ophthalmology
  - Ankara, Turkey, 06490
    - Ankara Baskent University Medical Faculty; Department of Ophthalmology
  - Ankara, Turkey, 06100
    - Hacettepe University Medical Faculty; Department of Ophthalmology
  - Istanbul, Turkey, 34421
    - Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology
  - Izmir, Turkey, 35100
    - Ege University Medical Faculty; Department of Ophthalmology
  - Kocaeli, Turkey, 41380
    - Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology
  - Konya, Turkey, 42130
    - Selcuk University Faculty of Medicine; Department Of Ophthalmology
United Kingdom
- - Belfast, United Kingdom, BT12 6BA
    - Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL
  - Bradford, United Kingdom, BD9 6RJ
    - Bradford Royal Infirmary
  - Canterbury, United Kingdom, CT1 3NG
    - East Kent Hospitals University NHS Foundation Trust
  - Frimley, United Kingdom, GU16 7UJ
    - Frimley Park Hospital
  - Gloucestershire, United Kingdom, GL1 3NN
    - Gloucestershire Hospitals NHS Foundation Trust
  - Leeds, United Kingdom, LS9 7TF
    - St James University Hospital
  - Liverpool, United Kingdom, L7 8YE
    - Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
  - London, United Kingdom, EC1V 2PD
    - Moorfields Eye Hospital NHS Foundation Trust
  - London, United Kingdom, NW3 2QS
    - Royal Free Hospital
  - London, United Kingdom, SW9 8RR
    - Kings College Hospital
  - Manchester, United Kingdom, M13 9WL
    - Manchester Royal Eye Hospital
  - Middx, United Kingdom, UB8 3NN
    - Hillingdon Hospital
  - Newcastle upon Tyne, United Kingdom, NE1 4LP
    - Royal Victoria Infirmary
  - Norfolk, United Kingdom, NR31 6LA
    - James Paget University Hospitals NHS Foundation Trust
  - Southampton, United Kingdom, SO16 6YD
    - University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit
  - Sunderland, United Kingdom, SR2 9HP
    - Sunderland Eye Infirmary
United States
- Arizona
  - Mesa, Arizona, United States, 85206
    - Barnet Dulaney Perkins Eye Center
  - Phoenix, Arizona, United States, 85014
    - Retinal Research Institute, LLC
  - Phoenix, Arizona, United States, 85016
    - Arizona Retina and Vitreous Consultants
  - Tucson, Arizona, United States, 85704
    - Retina Associates Southwest PC
- California
  - Bakersfield, California, United States, 93309
    - California Retina Consultants
  - Beverly Hills, California, United States, 90211
    - Retina-Vitreous Associates Medical Group
  - Campbell, California, United States, 95008
    - Retinal Diagnostic Center
  - Encino, California, United States, 91436
    - The Retina Partners
  - Fresno, California, United States, 93720
    - Eye Medical Center
  - Fullerton, California, United States, 92835-3424
    - Retina Consultants of Orange County
  - Los Angeles, California, United States, 90027
    - Southern California Permanente Medical Group
  - Mountain View, California, United States, 94040
    - Northern California Retina Vitreous Associates
  - Oakland, California, United States, 94609
    - East Bay Retina Consultants
  - Palm Desert, California, United States, 92211
    - Southern CA Desert Retina Cons
  - Pasadena, California, United States, 91107
    - California Eye Specialists Medical group Inc.
  - Poway, California, United States, 92064
    - Retina Consultants, San Diego
  - Redlands, California, United States, 92373
    - Retina Consultants of Southern California
  - Sacramento, California, United States, 95825
    - Retinal Consultants Med Group
  - San Francisco, California, United States, 94109
    - West Coast Retina Medical Group
  - Santa Ana, California, United States, 92705
    - Orange County Retina Med Group
  - Santa Barbara, California, United States, 93103
    - California Retina Consultants
  - Santa Maria, California, United States, 93454
    - California Retina Consultants - Santa Maria
  - Walnut Creek, California, United States, 94598
    - Bay Area Retina Associates
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado; dept of ophthalmology
  - Colorado Springs, Colorado, United States, 80909
    - Retina Consultants of Southern
  - Lakewood, Colorado, United States, 80228
    - Colorado Retina Associates, PC
- Connecticut
  - Waterford, Connecticut, United States, 06385
    - Retina Group of New England
- Florida
  - Deerfield Beach, Florida, United States, 33064
    - Rand Eye
  - Fort Lauderdale, Florida, United States, 33308
    - Retina Group of Florida
  - Fort Myers, Florida, United States, 33912
    - National Ophthalmic Research Institute
  - Melbourne, Florida, United States, 32901
    - Florida Eye Associates
  - Palm Beach Gardens, Florida, United States, 33410
    - Retina Care Specialists
  - Pensacola, Florida, United States, 32503
    - Retina Specialty Institute
  - Plantation, Florida, United States, 33324
    - Fort Lauderdale Eye Institute
  - Saint Petersburg, Florida, United States, 33711
    - Retina Vitreous Assoc of FL
  - Tallahassee, Florida, United States, 32308
    - Southern Vitreoretinal Assoc
  - Tampa, Florida, United States, 33609
    - Retina Associates of Florida, LLC
- Georgia
  - Augusta, Georgia, United States, 30909
    - Southeast Retina Center
  - Marietta, Georgia, United States, 30060-1137
    - Georgia Retina PC
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Retina Consultants of Hawaii
- Illinois
  - Oak Forest, Illinois, United States, 60452
    - University Retina and Macula Associates, PC
  - Springfield, Illinois, United States, 62704
    - Prairie Eye & LASIK Center / Prairie Retina Center
- Indiana
  - Indianapolis, Indiana, United States, 46290
    - Midwest Eye Institute
- Iowa
  - West Des Moines, Iowa, United States, 50266
    - Wolfe Eye Clinic
- Kansas
  - Lenexa, Kansas, United States, 66215
    - Retina Associates
  - Wichita, Kansas, United States, 67214
    - Vitreo-Retinal Consultants
- Kentucky
  - Lexington, Kentucky, United States, 40509
    - Retina Associates of Kentucky
- Maine
  - Portland, Maine, United States, 04101
    - Maine Eye Center
- Maryland
  - Baltimore, Maryland, United States, 21209
    - The Retina Care Center
  - Baltimore, Maryland, United States, 21287
    - Johns Hopkins Med; Wilmer Eye Inst
  - Chevy Chase, Maryland, United States, 20815
    - Retina Group of Washington
  - Hagerstown, Maryland, United States, 21740
    - Cumberland Valley Retina PC
  - Towson, Maryland, United States, 21204
    - Retina Specialists
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Ophthalmic Consultants of Boston
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center; Ophthalmology
  - Boston, Massachusetts, United States, 02215
    - Beetham Eye Institute, Joslin Diabetes Center
  - Worcester, Massachusetts, United States, 01605
    - Vitreo-Retinal Associates, PC
- Michigan
  - Grand Rapids, Michigan, United States, 49546
    - Vitreo-Retinal Associates
  - Grand Rapids, Michigan, United States, 49546
    - Foundation for Vision Research
  - Grand Rapids, Michigan, United States, 49546
    - Associated Retinal Consultants
  - Royal Oak, Michigan, United States, 48073
    - Assoc Retinal Consultants PC
  - Traverse City, Michigan, United States, 49686
    - Associated Retinal Consultants, P.C.
- Minnesota
  - Edina, Minnesota, United States, 55435
    - VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
- Missouri
  - Chesterfield, Missouri, United States, 63017
    - Midwest Vision Research Foundation
- Nevada
  - Reno, Nevada, United States, 89502
    - Sierra Eye Associates
- New Jersey
  - Edison, New Jersey, United States, 08820
    - NJRetina
  - Northfield, New Jersey, United States, 08225
    - Retinal & Ophthalmic Cons PC
  - Teaneck, New Jersey, United States, 07666
    - Retina Associates of NJ
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - University of New Mexico
- New York
  - Albany, New York, United States, 12206
    - Capital Region Retina
  - Hauppauge, New York, United States, 11788
    - Long Is. Vitreoretinal Consult
  - Liverpool, New York, United States, 13088
    - Retina Vit Surgeons/Central NY
  - New York, New York, United States, 10017
    - New York University
  - Oceanside, New York, United States, 11572
    - Ophthalmic Cons of Long Island
  - Rochester, New York, United States, 14620
    - Retina Associates of Western New York
  - Shirley, New York, United States, 11967
    - Island Retina
  - Slingerlands, New York, United States, 12159
    - The Retina Consultants
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - Western Carolina Retinal Associate PA
  - Charlotte, North Carolina, United States, 28210
    - Char Eye Ear &Throat Assoc
  - Hickory, North Carolina, United States, 28602
    - Graystone Eye
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest Baptist Health Eye Centre
- Ohio
  - Cincinnati, Ohio, United States, 45242
    - Cincinnati Eye Institute
  - Cleveland, Ohio, United States, 44122
    - Retina Assoc of Cleveland Inc
  - Cleveland, Ohio, United States, 44195-0001
    - Cleveland Clinic Foundation; Cole Eye Institute
  - Columbus, Ohio, United States, 43212
    - The Ohio State University Havener Eye Institute
  - Dublin, Ohio, United States, 43016
    - Midwest Retina
- Oklahoma
  - Edmond, Oklahoma, United States, 73013
    - Retina Vitreous Center
- Oregon
  - Portland, Oregon, United States, 97221
    - Retina Northwest
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19107
    - Mid-Atlantic Retina
  - Philadelphia, Pennsylvania, United States, 19107
    - Mid Atlantic Retina - Wills Eye Hospital
- South Carolina
  - Greenville, South Carolina, United States, 29605
    - Retina Consultants of Carolina
  - Ladson, South Carolina, United States, 29456
    - Charleston Neuroscience Inst
  - West Columbia, South Carolina, United States, 29169
    - Palmetto Retina Center
- Tennessee
  - Chattanooga, Tennessee, United States, 37421
    - Southeastern Retina Associates Chattanooga
  - Germantown, Tennessee, United States, 38138
    - Charles Retina Institute
  - Nashville, Tennessee, United States, 37203
    - Tennessee Retina PC
- Texas
  - Abilene, Texas, United States, 79606
    - Retina Res Institute of Texas
  - Austin, Texas, United States, 78750
    - Austin Clinical Research LLC
  - Austin, Texas, United States, 78705-1169
    - Austin Retina Associates
  - Bellaire, Texas, United States, 77401-3510
    - Retina & Vitreous of Texas
  - Dallas, Texas, United States, 75231
    - Texas Retina Associates
  - Harlingen, Texas, United States, 78550
    - Valley Retina Institute P.A.
  - San Antonio, Texas, United States, 78240
    - Medical Center Ophthalmology Associates
  - Southlake, Texas, United States, 76092
    - Retina Center of Texas
  - The Woodlands, Texas, United States, 77384-4167
    - Retina Consultants of Texas
  - Tyler, Texas, United States, 75701
    - Eye Care Assoc of East Texas
  - Willow Park, Texas, United States, 76087
    - Strategic Clinical Research Group, LLC
- Utah
  - Salt Lake City, Utah, United States, 84132
    - University of Utah; Division of Gastroenterology/Hepatology
  - Salt Lake City, Utah, United States, 84107
    - Retina Associates of Utah, PLLC
- Vermont
  - Burlington, Vermont, United States, 05405
    - Uni of Vermont Medical Center;
- Virginia
  - Charlottesville, Virginia, United States, 22903
    - Univ of Virginia Ophthalmology
  - Falls Church, Virginia, United States, 22042
    - Emerson Clinical Research Institute
  - Lynchburg, Virginia, United States, 24502
    - Piedmont Eye Center
  - Norfolk, Virginia, United States, 23502
    - Wagner Kapoor Institute
  - Richmond, Virginia, United States, 23235
    - Retina Institute of Virginia
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - West Virginia University Eye Institute
- Wisconsin
  - Madison, Wisconsin, United States, 53705
    - University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Previous enrollment in and completion of Study GR40349 (NCT03622580) or GR40398 (NCT03622593), without study or study drug discontinuation
Ability to comply with the study protocol, in the investigator's judgment
For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 3 months after the final dose of study treatment

Exclusion Criteria:

Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final intravitreal injection of faricimab
Presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections, study treatment procedure, dilating drops, or any of the anesthetic and antimicrobial preparations used by a patient during the study
Requirement for continuous use of any medications or treatments indicated as prohibited therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Faricimab PTI	Drug: Faricimab Faricimab will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen. Other Names: RO6867461 RG7716 Other: Sham Procedure The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. The sham procedure will be administered to participants as appropriate during the first 16 weeks of this study in order to maintain the masking of the initial faricimab PTI.

Participant Group / Arm

Intervention / Treatment

Experimental: Faricimab PTI

Drug: Faricimab

Faricimab will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen.

Other Names:

RO6867461
RG7716

Other: Sham Procedure

The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. The sham procedure will be administered to participants as appropriate during the first 16 weeks of this study in order to maintain the masking of the initial faricimab PTI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and Severity of Ocular Adverse Events Time Frame: Up to 2 years	Up to 2 years
Incidence and Severity of Systemic (Non-Ocular) Adverse Events Time Frame: Up to 2 years	Up to 2 years
Number of Participants with Presence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study Time Frame: From Baseline up to 2 years	From Baseline up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2020

Primary Completion (Actual)

October 11, 2023

Study Completion (Actual)

October 11, 2023

Study Registration Dates

First Submitted

June 12, 2020

First Submitted That Met QC Criteria

June 12, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

GR41987
2020-000402-29 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Diabetic Macular Edema

Clinical Trials on Faricimab

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