A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)
NCT ID: NCT03622580
Last Updated: 2025-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
940 participants
INTERVENTIONAL
2018-09-05
2021-09-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A: Faricimab 6 mg Q8W
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
Faricimab
Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B.
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. It was administered to participants in all three treatments arms at applicable clinic visits to maintain masking among treatment arms.
B: Faricimab 6 mg PTI
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections once every 4 weeks (Q4W), 8 weeks (Q8W), 12 weeks (Q12W), or 16 weeks (Q16W) up to Week 96, followed by the final study visit at Week 100.
Faricimab
Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B.
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. It was administered to participants in all three treatments arms at applicable clinic visits to maintain masking among treatment arms.
C: Aflibercept 2 mg Q8W
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
Aflibercept
Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).
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. It was administered to participants in all three treatments arms at applicable clinic visits to maintain masking among treatment arms.
Interventions
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Aflibercept
Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).
Faricimab
Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B.
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. It was administered to participants in all three treatments arms at applicable clinic visits to maintain masking among treatment arms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hemoglobin A1c (HbA1c) of less than or equal to (≤) 10% within 2 months prior to Day 1
* Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea
* Decreased visual acuity attributable primarily to DME
* Ability and willingness to undertake all scheduled visits and assessments
* 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
* Uncontrolled blood pressure, defined as a systolic value greater than (\>)180 millimeters of mercury (mmHg) and/or a diastolic value \>100 mmHg while a patient is at rest
* Currently pregnant or breastfeeding, or intend to become pregnant during the study
* Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
* Any intraocular or periocular corticosteroid treatment within the past 6 months prior to Day 1 to the study eye
* Prior administration of IVT faricimab in either eye
* Active intraocular or periocular infection or active intraocular inflammation in the study eye
* Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
* Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Barnet Dulaney Perkins Eye Center
Mesa, Arizona, United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, United States
Retina Associates Southwest PC
Tucson, Arizona, United States
Retinal Diagnostic Center
Campbell, California, United States
Eye Medical Center
Fresno, California, United States
East Bay Retina Consultants
Oakland, California, United States
Southern CA Desert Retina Cons
Palm Desert, California, United States
California Eye Specialists Medical group Inc.
Pasadena, California, United States
Retina Consultants, San Diego
Poway, California, United States
Retina Consultants of Southern California
Redlands, California, United States
Kaiser Permanente Riverside Medical Center
Riverside, California, United States
University of California, Davis, Eye Center
Sacramento, California, United States
W Coast Retina Med Group Inc
San Francisco, California, United States
Orange County Retina Med Group
Santa Ana, California, United States
Colorado Retina Associates, PC
Lakewood, Colorado, United States
Rand Eye
Deerfield Beach, Florida, United States
Retina Care Specialists
Palm Beach Gardens, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Southern Vitreoretinal Assoc
Tallahassee, Florida, United States
Retina Associates of Florida, LLC
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
Georgia Retina PC
Marietta, Georgia, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
Retina Associates
Lenexa, Kansas, United States
Vitreo-Retinal Consultants
Wichita, Kansas, United States
Retina Associates of Kentucky
Lexington, Kentucky, United States
Paducah Retinal Center
Paducah, Kentucky, United States
Maine Eye Center
Portland, Maine, United States
The Retina Care Center
Baltimore, Maryland, United States
Johns Hopkins Med; Wilmer Eye Inst
Baltimore, Maryland, United States
Retina Group of Washington
Chevy Chase, Maryland, United States
Cumberland Valley Retina PC
Hagerstown, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Beetham Eye Institute, Joslin Diabetes Center
Boston, Massachusetts, United States
Vitreo-Retinal Associates, PC
Worcester, Massachusetts, United States
Foundation for Vision Research
Grand Rapids, Michigan, United States
Assoc Retinal Consultants PC
Royal Oak, Michigan, United States
Associated Retinal Consultants, P.C.
Traverse City, Michigan, United States
Vitreoretinal Surgery
Edina, Minnesota, United States
Midwest Vision Research Foundation
Chesterfield, Missouri, United States
Sierra Eye Associates
Reno, Nevada, United States
Mid Atlantic Retina - Wills Eye Hospital
Cherry Hill, New Jersey, United States
NJ Retina
Edison, New Jersey, United States
Retinal & Ophthalmic Cons PC
Northfield, New Jersey, United States
Retina Associates of NJ
Teaneck, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Capital Region Retina
Albany, New York, United States
Long Is. Vitreoretinal Consult
Great Neck, New York, United States
Retina Vit Surgeons/Central NY
Liverpool, New York, United States
MaculaCare, PLLC
New York, New York, United States
Island Retina
Shirley, New York, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, United States
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, United States
Graystone Eye
Hickory, North Carolina, United States
Carolina Eye Associates
Southern Pines, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Retina Assoc of Cleveland Inc
Cleveland, Ohio, United States
OSU Eye Physicians & Surgeons
Columbus, Ohio, United States
Midwest Retina
Dublin, Ohio, United States
Retina Vitreous Center
Edmond, Oklahoma, United States
Retina Northwest
Portland, Oregon, United States
Black Hills Eye Institute
Rapid City, South Dakota, United States
Charles Retina Institute
Memphis, Tennessee, United States
Retina Res Institute of Texas
Abilene, Texas, United States
Austin Clinical Research LLC
Austin, Texas, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Retina Specialists
DeSoto, Texas, United States
Valley Retina Institute P.A.
Harlingen, Texas, United States
Retina & Vitreous of Texas
Houston, Texas, United States
Med Center Ophthalmology Assoc
San Antonio, Texas, United States
Eye Care Assoc of East Texas
Tyler, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
Retina Associates of Utah
Salt Lake City, Utah, United States
University of Utah; Division of Gastroenterology/Hepatology
Salt Lake City, Utah, United States
University of Vermont Medical Center; Investigational Drug Service, Pharmacy Department/Baird 1
Burlington, Vermont, United States
Emerson Clinical Research Institute
Falls Church, Virginia, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Wagner Macula & Retina Center
Norfolk, Virginia, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
West Virginia University Eye Institute
Morgantown, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
Graz, , Austria
Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
Linz, , Austria
Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
Vienna, , Austria
Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik
Vienna, , Austria
Medical Center for Eye Health - Focus Ltd
Sofia, , Bulgaria
Pentagram Eye Hospital (Medical Center "Pentagram")
Sofia, , Bulgaria
Spec. Ophth. Hospital for Active Treatment- Academic Pashev
Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Eye Diseases Zora
Sofia, , Bulgaria
Ambulatory - Medical Center for Specialized Medical Assistance - "Eye Clinic Sveta Petka" Ltd
Varna, , Bulgaria
Hopital Pellegrin; Ophtalmologie
Bordeaux, , France
Pole Vision Val d'Ouest; Ophtalmologie
Écully, , France
Centre Paradis Monticelli; Ophtalmologie
Marseille, , France
CHU Nantes - Hôtel Dieu; Ophthalmology
Nantes, , France
Centre Odeon; Exploration Ophtalmologique
Paris, , France
Hopital Lariboisiere; Ophtalmologie
Paris, , France
Universitäts-Augenklinik Bonn
Bonn, , Germany
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde 3.B1.266
Göttingen, , Germany
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
Mainz, , Germany
Augenabteilung am St. Franziskus-Hospital
Münster, , Germany
Universitätsklinikum Münster; Augenheilkunde
Münster, , Germany
Budapest Retina Associates Kft.
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
Debrecen, , Hungary
Ganglion Medial Center
Pécs, , Hungary
Szegedi Tudományegyetem ÁOK; Department of Ophtalmology
Szeged, , Hungary
Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET
Szombathely, , Hungary
Zala Megyei Kórház; SZEMESZET
Zalaegerszeg, , Hungary
Rambam Medical Center; Opthalmology
Haifa, , Israel
Hadassah MC; Ophtalmology
Jerusalem, , Israel
Rabin MC; Ophtalmology
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel Aviv Sourasky MC; Ophtalmology
Tel Aviv, , Israel
Ospedale Clinicizzato SS Annunziata; Clinica Oftalmologica
Chieti, Abruzzo, Italy
Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
Rome, Lazio, Italy
UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA
Genoa, Liguria, Italy
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
Milan, Lombardy, Italy
Irccs Ospedale San Raffaele;U.O. Oculistica
Milan, Lombardy, Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica
Perugia, Umbria, Italy
Sugita Eye Hospital
Aichi, , Japan
Nagoya University Hospital
Aichi, , Japan
Nagoya City University Hospital
Aichi, , Japan
Aichi Medical University Hospital
Aichi, , Japan
Toho University Sakura Medical Center
Chiba, , Japan
Hayashi Eye Hospital
Fukuoka, , Japan
Kurume University Hospital
Fukuoka, , Japan
Hokkaido University Hospital
Hokkaido, , Japan
Asahikawa Medical University Hospital
Hokkaido, , Japan
Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
Hyōgo, , Japan
Kozawa eye hospital and diabetes center
Ibaraki, , Japan
St. Marianna University Hospital
Kanagawa, , Japan
Ideta Eye Hospital
Kumamoto, , Japan
Kyoto University Hospital
Kyoto, , Japan
Mie University Hospital
Mie, , Japan
University of Miyazaki Hospital
Miyazaki, , Japan
Nara Medical University Hospital
Nara, , Japan
Kitano Hospital
Osaka, , Japan
Osaka City University Hospital
Osaka, , Japan
National Defense Medical College Hospital
Saitama, , Japan
Shiga University Of Medical Science Hospital
Shiga, , Japan
Seirei Hamamatsu General Hospital
Shizuoka, , Japan
Tokushima University Hospital
Tokushima, , Japan
Tokyo Women's Medical University Hospital
Tokyo, , Japan
Kyorin University Hospital
Tokyo, , Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, , Japan
Yamaguchi University Hospital
Yamaguchi, , Japan
Centro Oftalmológico Mira, S.C
Cuauhtémoc, Mexico CITY (federal District), Mexico
Macula Retina Consultores
México, , Mexico
Hospital de la Ceguera APEC
México, , Mexico
Instituto Mexicano de Oftalmologia I.A.P.
Querétaro, , Mexico
Mácula D&T
Lima, , Peru
Oftalmosalud Srl
Lima, , Peru
TG Laser Oftalmica
Lima, , Peru
Oftalmolaser
Lima, , Peru
Szpital sw. Lukasza
Bielsko-Biala, , Poland
Szpital Specjalistyczny nr 1; Oddzial Okulistyki
Bytom, , Poland
Dobry Wzrok Sp Z O O
Gdansk, , Poland
Gabinet Okulistyczny Prof Edward Wylegala
Katowice, , Poland
Centrum Medyczne UNO-MED
Krakow, , Poland
Optomed Sp. z o.o.
Rybnik, , Poland
Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina; Klinika Okulistyki
Rzeszów, , Poland
SPEKTRUM Osrodek Okulistyki Klinicznej
Wroclaw, , Poland
Clinic Optimed
Ufa, Bashkortostan Republic, Russia
FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences
Moscow, , Russia
Medical Military Academy n.a S.M.Kirov
Saint Petersburg, , Russia
Nemocnica s poliklinikou Trebišov, a.s.
Trebišov, , Slovakia
Fakultna nemocnica Trencin Ocna klinika
Trenčín, , Slovakia
Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
Žilina, , Slovakia
Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia
Santiago de Compostela, LA Coruña, Spain
Hospital Universitario de Gran Canaria; Servicio de oftalmologia
Las Palmas de Gran Canaria, LAS Palmas, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Clinica Universitaria de Navarra; Servicio de Oftalmologia
Pamplona, Navarre, Spain
Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia
Albacete, , Spain
VISSUM Instituto Oftalmológico de Alicante
Alicante, , Spain
Centro de Oftalmologia Barraquer; Servicio Oftalmologia
Barcelona, , Spain
Hospital Clinic de Barcelona; Consultas Externas Oftalmologia
Barcelona, , Spain
Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia
Barcelona, , Spain
Clinica Universitaria de Navarra; Servicio de Oftalmologia
Madrid, , Spain
Hacettepe University Medical Faculty; Department of Ophthalmology
Ankara, , Turkey (Türkiye)
Ege University Medical Faculty; Department of Ophthalmology
Izmir, , Turkey (Türkiye)
Selcuk University Faculty of Medicine; Department Of Ophthalmology
Konya, , Turkey (Türkiye)
Countries
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References
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Wong TY, Haskova Z, Asik K, Baumal CR, Csaky KG, Eter N, Ives JA, Jaffe GJ, Korobelnik JF, Lin H, Murata T, Ruamviboonsuk P, Schlottmann PG, Seres AI, Silverman D, Sun X, Tang Y, Wells JA, Yoon YH, Wykoff CC; YOSEMITE and RHINE Investigators. Faricimab Treat-and-Extend for Diabetic Macular Edema: Two-Year Results from the Randomized Phase 3 YOSEMITE and RHINE Trials. Ophthalmology. 2024 Jun;131(6):708-723. doi: 10.1016/j.ophtha.2023.12.026. Epub 2023 Dec 28.
Jaffe GJ, Deak G, Gibson K, Khurana RN, Nudleman E, Ogura Y, Schmidt-Erfurth U, Wang T, Westenskow PD, Wong D, Yiu G, Willis JR. IMPACT OF FARICIMAB VERSUS AFLIBERCEPT ON EPIRETINAL MEMBRANE FORMATION OVER 2 YEARS IN PATIENTS WITH DIABETIC MACULAR EDEMA IN THE PHASE 3 YOSEMITE AND RHINE TRIALS. Retina. 2025 Nov 1;45(11):2003-2011. doi: 10.1097/IAE.0000000000004572.
Gamble A, Khan T, Hughes A, Guo Y, Vasaitis S, Bidwell J, Christman B. Telehealth Diabetes Prevention Program for Adults With Prediabetes in an Academic Medical Center Setting: Protocol for a Hybrid Type III Trial. JMIR Res Protoc. 2023 Nov 13;12:e50183. doi: 10.2196/50183.
Stockwell AD, Chang MC, Mahajan A, Forrest W, Anegondi N, Pendergrass RK, Selvaraj S, Reeder J, Wei E, Iglesias VA, Creps NM, Macri L, Neeranjan AN, van der Brug MP, Scales SJ, McCarthy MI, Yaspan BL. Multi-ancestry GWAS analysis identifies two novel loci associated with diabetic eye disease and highlights APOL1 as a high risk locus in patients with diabetic macular edema. PLoS Genet. 2023 Aug 16;19(8):e1010609. doi: 10.1371/journal.pgen.1010609. eCollection 2023 Aug.
Shimura M, Kitano S, Ogata N, Mitamura Y, Oh H, Ochi H, Ohsawa S, Hirakata A; YOSEMITE and RHINE Investigators. Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in Japanese patients with diabetic macular edema: 1-year results from the Japan subgroup of the phase 3 YOSEMITE trial. Jpn J Ophthalmol. 2023 May;67(3):264-279. doi: 10.1007/s10384-023-00979-8. Epub 2023 Mar 10.
Eter N, Singh RP, Abreu F, Asik K, Basu K, Baumal C, Chang A, Csaky KG, Haskova Z, Lin H, Ruiz CQ, Ruamviboonsuk P, Silverman D, Wykoff CC, Willis JR. YOSEMITE and RHINE: Phase 3 Randomized Clinical Trials of Faricimab for Diabetic Macular Edema: Study Design and Rationale. Ophthalmol Sci. 2021 Dec 30;2(1):100111. doi: 10.1016/j.xops.2021.100111. eCollection 2022 Mar.
Wykoff CC, Abreu F, Adamis AP, Basu K, Eichenbaum DA, Haskova Z, Lin H, Loewenstein A, Mohan S, Pearce IA, Sakamoto T, Schlottmann PG, Silverman D, Sun JK, Wells JA, Willis JR, Tadayoni R; YOSEMITE and RHINE Investigators. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022 Feb 19;399(10326):741-755. doi: 10.1016/S0140-6736(22)00018-6. Epub 2022 Jan 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-005104-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GR40349
Identifier Type: -
Identifier Source: org_study_id
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