A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema
Rhone-X
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Diabetic Macular Edema
2 other identifiers
interventional
1,479
29 countries
316
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2020
Typical duration for phase_3
316 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
August 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2023
CompletedResults Posted
Study results publicly available
October 30, 2024
CompletedFebruary 9, 2026
January 1, 2026
3.2 years
June 12, 2020
October 7, 2024
January 21, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
This is an analysis of participants with at least one ocular adverse event (AE) that occurred in the study eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity (e.g., mild, moderate, or severe intensity), and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.
From the day of the first dose of faricimab until the end of the study (up to 108 weeks)
Incidence of Ocular Adverse Events in the Fellow Eye
This is an analysis of participants with at least one ocular adverse event (AE) that occurred in the fellow eye (i.e., non-study eye). Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity, and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.
From the day of the first dose of faricimab until the end of the study (up to 108 weeks)
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale
This is an analysis of participants with at least one non-ocular (systemic) adverse event (AE). Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity (e.g., mild, moderate, or severe intensity), and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.
From the day of the first dose of faricimab until the end of the study (up to 108 weeks)
Study Arms (1)
Faricimab PTI
EXPERIMENTALInterventions
Faricimab will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (320)
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, 85206, United States
Retinal Research Institute, LLC
Phoenix, Arizona, 85014, United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, 85016, United States
Retina Associates Southwest PC
Tucson, Arizona, 85704, United States
California Retina Consultants.
Bakersfield, California, 93309, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Retinal Diagnostic Center
Campbell, California, 95008, United States
The Retina Partners
Encino, California, 91436, United States
Eye Medical Center
Fresno, California, 93720, United States
Retina Consultants of Orange County
Fullerton, California, 92835-3424, United States
Southern California Permanente Medical Group
Los Angeles, California, 90027, United States
Northern California Retina Vitreous Associates
Mountain View, California, 94040, United States
East Bay Retina Consultants
Oakland, California, 94609, United States
Southern CA Desert Retina Cons
Palm Desert, California, 92211, United States
California Eye Specialists Medical group Inc.
Pasadena, California, 91107, United States
Retina Consultants, San Diego
Poway, California, 92064, United States
Retina Consultants of Southern California
Redlands, California, 92373, United States
Retinal Consultants Med Group
Sacramento, California, 95825, United States
West Coast Retina Medical Group
San Francisco, California, 94109, United States
Orange County Retina Med Group
Santa Ana, California, 92705, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
California Retina Consultants - Santa Maria
Santa Maria, California, 93454, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
University of Colorado; dept of ophthalmology
Aurora, Colorado, 80045, United States
Retina Consultants of Southern
Colorado Springs, Colorado, 80909, United States
Colorado Retina Associates, PC
Lakewood, Colorado, 80228, United States
Retina Group of New England
Waterford, Connecticut, 06385, United States
Rand Eye
Deerfield Beach, Florida, 33064, United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308, United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912, United States
Florida Eye Associates
Melbourne, Florida, 32901, United States
Retina Care Specialists
Palm Beach Gardens, Florida, 33410, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324, United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida, 33711, United States
Southern Vitreoretinal Assoc
Tallahassee, Florida, 32308, United States
Retina Associates of Florida, LLC
Tampa, Florida, 33609, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Georgia Retina PC
Marietta, Georgia, 30060-1137, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, 60452, United States
Prairie Eye & LASIK Center / Prairie Retina Center
Springfield, Illinois, 62704, United States
Midwest Eye Institute
Indianapolis, Indiana, 46290, United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266, United States
Retina Associates
Lenexa, Kansas, 66215, United States
Vitreo-Retinal Consultants
Wichita, Kansas, 67214, United States
Retina Associates of Kentucky
Lexington, Kentucky, 40509, United States
Maine Eye Center
Portland, Maine, 04101, United States
The Retina Care Center
Baltimore, Maryland, 21209, United States
Johns Hopkins Med; Wilmer Eye Inst
Baltimore, Maryland, 21287, United States
Retina Group of Washington
Chevy Chase, Maryland, 20815, United States
Cumberland Valley Retina PC
Hagerstown, Maryland, 21740, United States
Retina Specialists
Towson, Maryland, 21204, United States
Tufts Medical Center; Ophthalmology
Boston, Massachusetts, 02111, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Beetham Eye Institute, Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Vitreo-Retinal Associates, PC
Worcester, Massachusetts, 01605, United States
Associated Retinal Consultants
Grand Rapids, Michigan, 49546, United States
Foundation for Vision Research
Grand Rapids, Michigan, 49546, United States
Vitreo-Retinal Associates
Grand Rapids, Michigan, 49546, United States
Assoc Retinal Consultants PC
Royal Oak, Michigan, 48073, United States
Associated Retinal Consultants, P.C.
Traverse City, Michigan, 49686, United States
VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
Edina, Minnesota, 55435, United States
Midwest Vision Research Foundation
Chesterfield, Missouri, 63017, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
NJRetina
Edison, New Jersey, 08820, United States
Retinal & Ophthalmic Cons PC
Northfield, New Jersey, 08225, United States
Retina Associates of NJ
Teaneck, New Jersey, 07666, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Capital Region Retina
Albany, New York, 12206, United States
Long Is. Vitreoretinal Consult
Great Neck, New York, 11021, United States
Long Is. Vitreoretinal Consult
Hauppauge, New York, 11788, United States
Retina Vit Surgeons/Central NY
Liverpool, New York, 13088, United States
New York University
New York, New York, 10017, United States
Ophthalmic Cons of Long Island
Oceanside, New York, 11572, United States
Retina Associates of Western New York
Rochester, New York, 14620, United States
Island Retina
Shirley, New York, 11967, United States
The Retina Consultants
Slingerlands, New York, 12159, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, 28803, United States
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, 28210, United States
Graystone Eye
Hickory, North Carolina, 28602, United States
Wake Forest Baptist Health Eye Centre
Winston-Salem, North Carolina, 27157, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Retina Assoc of Cleveland Inc
Cleveland, Ohio, 44122, United States
Cleveland Clinic Foundation; Cole Eye Institute
Cleveland, Ohio, 44195-0001, United States
The Ohio State University Havener Eye Institute
Columbus, Ohio, 43212, United States
Midwest Retina
Dublin, Ohio, 43016, United States
Retina Vitreous Center
Edmond, Oklahoma, 73013, United States
Retina Northwest
Portland, Oregon, 97221, United States
Mid Atlantic Retina - Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
Mid-Atlantic Retina
Philadelphia, Pennsylvania, 19107, United States
Retina Consultants Of Carolina
Greenville, South Carolina, 29605, United States
Charleston Neuroscience Inst
Ladson, South Carolina, 29456, United States
Palmetto Retina Center
West Columbia, South Carolina, 29169, United States
Southeastern Retina Associates Chattanooga
Chattanooga, Tennessee, 37421, United States
Charles Retina Institute
Germantown, Tennessee, 38138, United States
Tennessee Retina PC
Nashville, Tennessee, 37203, United States
Retina Res Institute of Texas
Abilene, Texas, 79606, United States
Austin Retina Associates
Austin, Texas, 78705-1169, United States
Austin Clinical Research LLC
Austin, Texas, 78750, United States
Retina & Vitreous of Texas
Bellaire, Texas, 77401-3510, United States
Retina Consultants of Texas
Bellaire, Texas, 77401, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Valley Retina Institute P.A.
Harlingen, Texas, 78550, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Retina Center of Texas
Southlake, Texas, 76092, United States
Retina Consultants of Texas
The Woodlands, Texas, 77384-4167, United States
Eye Care Assoc of East Texas
Tyler, Texas, 75701, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087, United States
Retina Associates of Utah, PLLC
Salt Lake City, Utah, 84107, United States
University of Utah; Division of Gastroenterology/Hepatology
Salt Lake City, Utah, 84132, United States
Uni of Vermont Medical Center;
Burlington, Vermont, 05405, United States
Univ of Virginia Ophthalmology
Charlottesville, Virginia, 22903, United States
Emerson Clinical Research Institute
Falls Church, Virginia, 22042, United States
Piedmont Eye Center
Lynchburg, Virginia, 24502, United States
Wagner Kapoor Institute
Norfolk, Virginia, 23502, United States
Retina Institute of Virginia
Richmond, Virginia, 23235, United States
West Virginia University Eye Institute
Morgantown, West Virginia, 26506, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
Fundacion Zambrano
CABA, C1017AAO, Argentina
Oftalmos
Capital Federal, C1120AAN, Argentina
Oftar
Mendoza, M5500GGK, Argentina
Centro Oftalmólogos Especialistas
Rosario, S2000ANJ, Argentina
Grupo Laser Vision
Rosario, S2000DLA, Argentina
Organizacion Medica de Investigacion
San Nicolás, C1015ABO, Argentina
Strathfield Retina Clinic
Strathfield, New South Wales, 2135, Australia
Sydney Eye Hospital
Sydney, New South Wales, 2000, Australia
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, 2000, Australia
Sydney West Retina
Westmead, New South Wales, 2145, Australia
Centre For Eye Research Australia
East Melbourne, Victoria, 3002, Australia
Retina Specialists Victoria
Rowville, Victoria, 3178, Australia
The Lions Eye Institute
Nedlands, Western Australia, 6009, Australia
LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
Graz, 8036, Austria
Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
Linz, 4021, Austria
Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
Vienna, 1090, Austria
Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik
Vienna, 1140, Austria
Hospital de Olhos de Aparecida - HOA
Aparecida de Goiânia, Goiás, 74980-010, Brazil
Centro Brasileiro de Cirurgia
Goiânia, Goiás, 74210-010, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Botelho Hospital da Visao
Blumenau, Santa Catarina, 89052-504, Brazil
Faculdade de Medicina do ABC - FMABC
Santo André, São Paulo, 09060-650, Brazil
Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
São Paulo, São Paulo, 04023-062, Brazil
CEMAPE - Centro Médico
São Paulo, São Paulo, 04084-002, Brazil
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, 05403-010, Brazil
Hosp de Olhos de Sorocaba
Sorocaba, São Paulo, 18031-060, Brazil
Medical Center for Eye Health ? Focus Ltd
Sofia, 1303, Bulgaria
Pentagram Eye Hospital (Medical Center "Pentagram")
Sofia, 1309, Bulgaria
Spec. Ophth. Hospital for Active Treatment- Academic Pashev
Sofia, 1517, Bulgaria
Specialized Hospital for Active Treatment of Eye Diseases Zora
Sofia, 1784, Bulgaria
Calgary Retina Consultants
Calgary, Alberta, T2J 0C8, Canada
QEII - HSC Department of Ophthalmology
Halifax, Nova Scotia, B3H 2Y9, Canada
Ivey Eye Institute
London, Ontario, N6A 4V2, Canada
Toronto Retina Institute
Toronto, Ontario, M3C 0G9, Canada
St. Michael's Hospital; Department of Ophthalmology
Toronto, Ontario, M5C 2T2, Canada
University Health Network Toronto Western Hospital
Toronto, Ontario, M5T 2S9, Canada
Institut De L'Oeil Des Laurentides
Boisbriand, Quebec, J7H 0E8, Canada
FN Hradec Králové, Ocní klinika; Ophthalmology clinic
Hradec Králové, 500 05, Czechia
Faculty Hospital Ostrava; Ophthalmology clinic
Ostrava, 708 52, Czechia
Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic
Prague, 100 34, Czechia
AXON Clinical
Prague, Czechia
Nemocnice Sokolov
Sokolov, 356 01, Czechia
Aalborg Universitetshospital; Øjenafdelingen
Aalborg, 9000, Denmark
Sjællands Universitetshospital, Roskilde; Øjenafdelingen
Roskilde, 4000, Denmark
Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin
Bordeaux, 33076, France
Chi De Creteil; Ophtalmologie
Créteil, 94010, France
Pole Vision Val d'Ouest; Ophtalmologie
Écully, 69130, France
CHU Nantes - Hôtel Dieu; Ophthalmology
Nantes, 44093, France
Hopital Lariboisiere; Ophtalmologie
Paris, 75010, France
Centres Ophtalmologique St Exupéry; Ophtalmologie
Saint-Cyr-sur-Loire, 37540, France
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde
Dresden, 01307, Germany
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, 79106, Germany
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover, 30625, Germany
Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde
Homburg/Saar, 66424, Germany
Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik
Magdeburg, 39120, Germany
LMU Klinikum der Universität, Augenklinik
München, 80336, Germany
Klinikum rechts der Isar der TU München; Augenklinik
München, 81675, Germany
Augenabteilung am St. Franziskus-Hospital
Münster, 48145, Germany
Universitätsklinikum Münster; Augenheilkunde
Münster, 48149, Germany
Universitätsklinikum Würzburg, Augenklinik und Poliklinik
Würzburg, 97080, Germany
Queen Mary Hospital; Department of Ophthalmology
Hong Kong, Hong Kong
Hong Kong Eye Hospital; CUHK Eye Centre
Mong Kok, Hong Kong
Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Szemeszet
Budapest, 1068, Hungary
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
Budapest, 1076, Hungary
Semmelweis Egyetem Szemészeti Vizsgálóhely
Budapest, 1085, Hungary
Bajcsy-Zsilinszky Hospital
Budapest, 1106, Hungary
Budapest Retina Associates Kft.
Budapest, 1133, Hungary
Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
Debrecen, 4032, Hungary
Ganglion Medial Center
Pécs, 7621, Hungary
Szegedi Tudományegyetem ÁOK; Department of Ophtalmology
Szeged, 6720, Hungary
Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET; Intezeti Gyogyszertar
Szombathely, 9700, Hungary
Zala Megyei Kórház; SZEMESZET
Zalaegerszeg, 8900, Hungary
Rambam Medical Center; Opthalmology
Haifa, 3109601, Israel
Hadassah MC; Ophtalmology
Jerusalem, 9112001, Israel
Rabin MC; Ophtalmology
Petah Tikva, 4941492, Israel
Kaplan Medical Center; Ophtalmology
Rehovot, 7660101, Israel
Tel Aviv Sourasky MC; Ophtalmology
Tel Aviv, 6423906, Israel
Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
Rome, Lazio, 00198, Italy
UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA
Genoa, Liguria, 16132, Italy
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
Milan, Lombardy, 20100, Italy
Irccs Ospedale San Raffaele;U.O. Oculistica
Milan, Lombardy, 20132, Italy
Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
Florence, Tuscany, 50134, Italy
Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria
Pisa, Tuscany, 56124, Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica
Perugia, Umbria, 06129, Italy
Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria; Presso Ufficio Cassa
Negrar - Verona, Veneto, 37024, Italy
Sugita Eye Hospital
Aichi, 460-0008, Japan
Nagoya University Hospital
Aichi, 466-8560, Japan
Nagoya City University Hospital
Aichi, 467-8602, Japan
Aichi Medical University Hospital
Aichi, 480-1195, Japan
Toho University Sakura Medical Center
Chiba, 285-8741, Japan
Hayashi Eye Hospital
Fukuoka, 812-0011, Japan
Kurume University Hospital
Fukuoka, 830-0011, Japan
Hokkaido University Hospital
Hokkaido, 060-8648, Japan
Asahikawa Medical University Hospital
Hokkaido, 078-8510, Japan
Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
Hyōgo, 660-8550, Japan
Kozawa eye hospital and diabetes center
Ibaraki, 310-0845, Japan
Ideta Eye Hospital
Kumamoto, 860-0027, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Mie University Hospital
Mie, 514-8507, Japan
University of Miyazaki Hospital
Miyazaki, 889-1692, Japan
Nara Medical University Hospital
Nara, 634-8522, Japan
Kitano Hospital
Osaka, 530-8480, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
National Defense Medical College Hospital
Saitama, 359-8513, Japan
Shiga University Of Medical Science Hospital
Shiga, 520-2192, Japan
Tokyo Women's Medical University
Tokyo, 162-0054, Japan
Kyorin University Hospital
Tokyo, 181-8611, Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, 193-0998, Japan
Centro Oftalmológico Mira, S.C
Del. Cuauhtemoc, Mexico CITY (federal District), 06760, Mexico
Macula Retina Consultores
México, Mexico CITY (federal District), 01120, Mexico
Hospital de la Ceguera APEC
México, Mexico CITY (federal District), 04030, Mexico
Instituto de la retina del Bajio
Querétaro City, Querétaro, 76180, Mexico
Mácula D&T
Lima, 27, Peru
TG Laser Oftalmica
Lima, 27, Peru
Oftalmolaser
Lima, Lima 33, Peru
Szpital sw. Lukasza
Bielsko-Biala, 43-309, Poland
Specjalistyczny Osrodek Okulistyczny Oculomedica
Bydgoszcz, 85-316, Poland
OFTALMIKA Sp. z o.o
Bydgoszcz, 85-631, Poland
Szpital Specjalistyczny nr 1; Oddzial Okulistyki
Bytom, 41-902, Poland
Dobry Wzrok Sp Z O O
Gdansk, 80-402, Poland
Optimum Profesorskie Centrum Okulistyki
Gdansk, 80-809, Poland
Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
Gliwice, 44-100, Poland
Gabinet Okulistyczny Prof Edward Wylegala
Katowice, 40-594, Poland
Centrum Medyczne UNO-MED
Krakow, 31-070, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
Krakow, 31-501, Poland
Optomed Sp. z o.o.
Rybnik, 44-203, Poland
Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow
Rzeszów, 35-017, Poland
Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina; Klinika Okulistyki
Rzeszów, 35-055, Poland
Caminomed
Tarnowskie Góry, 42-600, Poland
Centrum Zdrowia MDM
Warsaw, 00-189, Poland
SPEKTRUM Osrodek Okulistyki Klinicznej
Wroclaw, 53-334, Poland
Hospital de Braga; Servico de Oftalmologia
Braga, 4710-243, Portugal
AIBILI - Association for Innovation and Biomedical Research on Light
Coimbra, 3000-548, Portugal
Espaco Medico Coimbra
Coimbra, 3030-163, Portugal
Hospital de Santa Maria; Servico de Oftalmologia
Lisbon, 1649-035, Portugal
Clinic Optimed
Ufa, Bashkortostan Republic, 450059, Russia
Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch
Cheboksary, Mariy-El Republic, 428000, Russia
FSBI ?Scientific Research Institute of Eye Diseases? of Russian Academy of medical Sciences
Moscow, Moscow Oblast, 119435, Russia
Medical Military Academy n.a S.M.Kirov
Saint Petersburg, Sankt-Peterburg, 124044, Russia
Clinics of Eye Diseases, LLC
Kazan', Tatarstan Republic, 420066, Russia
?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch
Irkutsk, 664033, Russia
?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch
Novosibirsk, 630096, Russia
National University Hospital; Ophthalmology Department
Singapore, 119074, Singapore
Singapore Eye Research Institute
Singapore, 168751, Singapore
Tan Tock Seng Hospital; Ophthalmology Department
Singapore, 308433, Singapore
Nemocnica s poliklinikou Trebišov, a.s.
Trebišov, 075 01, Slovakia
Fakultna nemocnica Trencin Ocna klinika
Trenčín, 911 71, Slovakia
Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
Žilina, 012 07, Slovakia
Seoul National University Bundang Hospital
Seongnam-si, 463-707, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, 08195, Spain
Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia
Santiago de Compostela, LA Coruña, 15706, Spain
Hospital Universitario de Gran Canaria; Servicio de oftalmologia
Las Palmas de Gran Canaria, LAS Palmas, 35016, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Clinica Universitaria de Navarra; Servicio de Oftalmologia
Pamplona, Navarre, 31008, Spain
Complejo Hospitalario de Navarra; Servicio de oftalmologia
Pamplona, Navarre, 31008, Spain
Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia
Oviedo, Principality of Asturias, 33012, Spain
Oftalvist Valencia
Burjassot, Valencia, 46100, Spain
Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia
Albacete, 02006, Spain
VISSUM Instituto Oftalmológico de Alicante
Alicante, 03016, Spain
Centro de Oftalmologia Barraquer; Servicio Oftalmologia
Barcelona, 08021, Spain
Hospital dos de maig; servicio de oftalmologia
Barcelona, 08025, Spain
Hospital Clinic de Barcelona; Consultas Externas Oftalmologia
Barcelona, 08028, Spain
Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia
Barcelona, 08041, Spain
Clinica Baviera; Servicio Oftalmologia
Madrid, 28046, Spain
Fisabio-Ofalmologia Medica; Servicio de Oftalmología
Valencia, 46015, Spain
Hospital Universitario Rio Hortega; Servicio de Oftalmologia
Valladolid, 47012, Spain
Vista Klinik Ophthalmologische Klinik
Binningen, 4102, Switzerland
Taipei Veterans General Hospital; Ophthalmology
Taipei, 11217, Taiwan
Chang Gung Medical Foundation - Linkou; Ophthalmology
Taoyuan District, 333, Taiwan
National Taiwan University Hospital; Ophthalmology
Zhongzheng Dist., 10002, Taiwan
King Chulalongkorn Memorial Hospital; Ophthalmology Department
Bangkok, 10330, Thailand
Rajavithi Hospital; Ophthalmology Department
Bangkok, 10400, Thailand
Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department
Chiang Mai, 50200, Thailand
Hacettepe University Medical Faculty; Department of Ophthalmology
Ankara, 06100, Turkey (Türkiye)
Ankara University Medical Faculty; Department of Ophthalmology
Ankara, 06340, Turkey (Türkiye)
Ankara Baskent University Medical Faculty; Department of Ophthalmology
Ankara, 06490, Turkey (Türkiye)
Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology
Istanbul, 34421, Turkey (Türkiye)
Ege University Medical Faculty; Department of Ophthalmology
Izmir, 35100, Turkey (Türkiye)
Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology
Kocaeli, 41380, Turkey (Türkiye)
Selcuk University Faculty of Medicine; Department Of Ophthalmology
Konya, 42130, Turkey (Türkiye)
Hillingdon Hospital
Uxbridge, Middx, UB8 3NN, United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, Norfolk, NR31 6LA, United Kingdom
Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL
Belfast, BT12 6BA, United Kingdom
Bradford Royal Infirmary
Bradford, BD9 6RJ, United Kingdom
East Kent Hospitals University NHS Foundation Trust
Canterbury, CT1 3NG, United Kingdom
Frimley Park Hospital
Frimley, GU16 7UJ, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, GL1 3NN, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
Liverpool, L7 8YE, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD, United Kingdom
Royal Free Hospital
London, NW3 2QS, United Kingdom
Kings College Hospital
London, SW9 8RR, United Kingdom
Manchester Royal Eye Hospital
Manchester, M13 9WL, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit
Southampton, SO16 6YD, United Kingdom
Sunderland Eye Infirmary
Sunderland, SR2 9HP, United Kingdom
Related Publications (1)
Sheth VS, Schlottmann P, Lai TYY, Abreu F, Chang A, Eter N, Gibson K, Hu AY, Korobelnik JF, Kotak A, Kotecha A, O'Leary OE, Pearce I, Sim DA, Sun JK, Tang Y, Khanani AM. Four-Year Outcomes of Faricimab in Diabetic Macular Edema: Results from the RHONE-X Extension Trial. Ophthalmology. 2026 Jan 12:S0161-6420(26)00004-7. doi: 10.1016/j.ophtha.2026.01.001. Online ahead of print.
PMID: 41534798RESULT
MeSH Terms
Interventions
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Masking Details
- The first 16 weeks of this study will be a masked period (to transition from the multi-arm parent studies) during which participants may receive either faricimab or sham injection. Participants and physicians will be masked only to the faricimab treatment interval. After the Week 16 treatment procedure, this study will follow an open-label design. The BCVA examiner will remain masked for the duration of this long-term extension study.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2020
First Posted
June 16, 2020
Study Start
August 5, 2020
Primary Completion
October 11, 2023
Study Completion
October 11, 2023
Last Updated
February 9, 2026
Results First Posted
October 30, 2024
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing