A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema
RHINE
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)
2 other identifiers
interventional
951
24 countries
188
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2018
Longer than P75 for phase_3
188 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
August 1, 2018
CompletedFirst Posted
Study publicly available on registry
August 9, 2018
CompletedStudy Start
First participant enrolled
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2020
CompletedResults Posted
Study results publicly available
March 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedJuly 11, 2025
July 1, 2025
2 years
August 1, 2018
February 23, 2022
July 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded. 97.5% CI is a rounding of 97.52% CI.
From Baseline through Week 56
Secondary Outcomes (59)
Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at Week 52, ITT and Treatment-Naive Populations
Baseline and Week 52
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population
Baseline, average of Weeks 48, 52, and 56
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
- +54 more secondary outcomes
Study Arms (3)
A: Faricimab 6 mg Q8W
EXPERIMENTALParticipants 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.
B: Faricimab 6 mg PTI
EXPERIMENTALParticipants 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 up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
C: Aflibercept 2 mg Q8W
ACTIVE COMPARATORParticipants 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.
Interventions
Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).
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.
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 visits to maintain masking among treatment arms.
Eligibility Criteria
You may qualify if:
- Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
- 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
You may not qualify if:
- Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (188)
Associated Retina Consultants
Phoenix, Arizona, 85020, United States
Retinal Research Institute, LLC
Phoenix, Arizona, 85053, United States
Northwest Arkansas Retina Associates
Springdale, Arkansas, 72764, United States
California Retina Consultants
Bakersfield, California, 93309, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
The Retina Partners
Encino, California, 91436, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
Northern California Retina Vitreous Associates
Mountain View, California, 94040, United States
Retinal Consultants Med Group
Sacramento, California, 95825, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
California Retina Consultants
Santa Maria, California, 93454, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
University of Colorado
Aurora, Colorado, 80045, United States
Retina Consultants of Southern
Colorado Springs, Colorado, 80909, United States
Retina Group of New England
Waterford, Connecticut, 06385, 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
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, 33418, United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324, United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida, 33711, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, 60452, United States
Prairie Retina Center
Springfield, Illinois, 62704, United States
Retina Specialists
Baltimore, Maryland, 21204, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Associated Retinal Consultants
Grand Rapids, Michigan, 49546, United States
Vitreo-Retinal Associates
Grand Rapids, Michigan, 49546, United States
Retina Consultants of Nevada
Las Vegas, Nevada, 89144, United States
Envision Ocular, LLC
Bloomfield, New Jersey, 07003, United States
Long Is. Vitreoretinal Consult
Hauppauge, New York, 11788, United States
New York University
New York, New York, 10017, United States
Ophthalmic Cons of Long Island
Oceanside, New York, 11572, United States
Retina Assoc of Western NY
Rochester, New York, 14620, United States
University of Rochester Flaum Eye Institute
Rochester, New York, 14642, United States
The Retina Consultants
Slingerlands, New York, 12159, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Mid Atlantic Retina - Wills Eye Hospital
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
Southeastern Retina Associates
Knoxville, Tennessee, 37922, United States
Tennessee Retina PC
Nashville, Tennessee, 37203, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Retina Consultants of Texas
Bellaire, Texas, 77401, United States
Retina Center of Texas
Southlake, Texas, 76092, United States
Univ of Virginia Ophthalmology
Charlottesville, Virginia, 22903, United States
Retina Institute of Virginia
Richmond, Virginia, 23235, United States
Pacific Northwest Retina
Silverdale, Washington, 98383, United States
Organizacion Medica de Investigacion
Buenos Aires, C1015ABO, Argentina
Fundacion Zambrano
CABA, 1023, Argentina
Oftalmos
Capital Federal, C1120AAN, Argentina
Oftar
Mendoza, M5500GGK, Argentina
Centro Oftalmólogos Especialistas
Rosario, S2000ANJ, Argentina
Grupo Laser Vision
Rosario, S2000DLA, 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
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, 90035-003, 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
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, 05403-000, Brazil
Hosp de Olhos de Sorocaba
Sorocaba, São Paulo, 18031-060, Brazil
Calgary Retina Consultants
Calgary, Alberta, T2J 0C8, Canada
University of British Columbia - Vancouver Coastal Health Authority
Vancouver, British Columbia, V5Z 1M9, Canada
QEII - HSC Department of Ophthalmology
Halifax, Nova Scotia, B3H 2Y9, Canada
Ivey Eye Institute
London, Ontario, N6A 4V2, Canada
University of Ottawa Eye Institute
Ottawa, Ontario, K1H 8L6, Canada
Toronto Retina Institute
Toronto, Ontario, M3C 0G9, Canada
Unity Health Toronto
Toronto, Ontario, M5C 2T2, Canada
University Health Network Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Institut De L'Oeil Des Laurentides
Boisbriand, Quebec, J7H 1S6, Canada
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, H1T 2M4, Canada
Beijing Friendship Hospital
Beijing, 100050, China
Beijing Tongren Hospital
Beijing, 100730, China
Peking Union Medical College Hospital
Beijing, 100730, China
The Second Hospital of Jilin University
Changchun, 130041, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Southwest Hospital , Third Military Medical University
Chongqing, 400014, China
Army Medical Center of PLA(Daping Hospital)
Chongqing, 400042, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, 510060, China
The Affiliated Eye Hospital of Nanjing Medical University
Nanjing, 210029, China
Shanghai Tenth People's Hospital
Shanghai, 200072, China
Shanghai First People's Hospital
Shanghai, 200080, China
Tianjin Eye Hospital
Tianjin, 300050, China
Tianjin Medical University Eye Hospital
Tianjin, 300070, China
Eye Hospital, Wenzhou Medical University
Wenzhou, 325027, China
Wuxi No.2 People's Hospital
Wuxi, 214000, China
FN Hradec Králové, O?ní klinika
Hradec Králové, 500 05, Czechia
Faculty Hospital Ostrava
Ostrava, 708 52, Czechia
Faculty Hospital Kralovske Vinohrady
Prague, 100 34, Czechia
AXON Clinical
Prague, Czechia
Nemocnice Sokolov
Sokolov, 356 01, Czechia
Aalborg Universitetshospital
Aalborg, 9000, Denmark
Rigshospitalet Glostrup
Glostrup Municipality, 2600, Denmark
Sjællands Universitetshospital, Roskilde
Roskilde, 4000, Denmark
Chi De Creteil
Créteil, 94010, France
Centre Ophtalmologique
Paris, 75015, France
Centres Ophtalmologique St Exupéry
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
Universitätsklinikum des Saarlandes
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
München, 81675, Germany
Universitätsklinikum Würzburg, Augenklinik und Poliklinik
Würzburg, 97080, Germany
The University of Hong Kong
Hong Kong, Hong Kong
Hong Kong Eye Hospital
Mong Kok, Hong Kong
Magyar Honvedseg Egeszsegugyi Kozpont
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
Fondazione Ptv Policlinico Tor Vergata Di Roma
Rome, Lazio, 00133, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany, 50134, Italy
Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello
Pisa, Tuscany, 56124, Italy
Ospedale Classificato Equiparato Sacro Cuore Don Calabria
Negrar, Veneto, 37024, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine
Udine, Veneto, 33100, Italy
OFTALMIKA Sp. z o.o
Bydgoszcz, 85-631, Poland
Specjalistyczny O?rodek Okulistyczny Oculomedica
Bydgoszcz, 85-870, Poland
Optimum Profesorskie Centrum Okulistyki
Gdansk, 80-809, Poland
Niepubliczny Zaklad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
Gliwice, 44-100, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
Krakow, 31-501, Poland
Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow
Rzeszów, 35-017, Poland
Caminomed
Tarnowskie Góry, 42-600, Poland
Centrum Zdrowia MDM
Warsaw, 00-631, Poland
Hospital de Braga
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
Lisbon, 1649-035, Portugal
Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov
Cheboksary, Mariy-El Republic, 428000, 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
Singapore, 119074, Singapore
Singapore Eye Research Institute
Singapore, 168751, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Asan Medical Center.
Seoul, 138-736, South Korea
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, 08195, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008, Spain
Instituto Oftalmologico Fernandez Vega
Oviedo, Principality of Asturias, 33012, Spain
Oftalvist Valencia
Burjassot, Valencia, 46100, Spain
Hospital dos de maig
Barcelona, 08025, Spain
Clinica Baviera
Madrid, 28046, Spain
Fisabio-Ofalmologia Medica
Valencia, 46015, Spain
Hospital Universitario Rio Hortega
Valladolid, 47012, Spain
Vista Klinik Ophthalmologische Klinik
Binningen, 4102, Switzerland
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, 333, Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Rajavithi Hospital
Bangkok, 10400, Thailand
Maharaj Nakorn ChiangMai Hospital
Chiang Mai, 50200, Thailand
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)
Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology
Kocaeli, 41380, Turkey (Türkiye)
Barnet Hospital
Barnet, EN5 3DJ, United Kingdom
Bradford Royal Infirmary
Bradford, BD9 6RJ, United Kingdom
University Hospitals Bristol NHS Foundation Trust, Bristol Eye Hospital
Bristol, BS1 2LX, United Kingdom
Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL
Bristol, BT12 6BA, 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
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, NR31 6LA, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
Royal Liverpool University Hospital
Liverpool, L7 8XP, 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, SE5 9RS, 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, SO16 6YD, United Kingdom
Sunderland Eye Infirmary
Sunderland, SR2 9HP, United Kingdom
Hillingdon Hospital
Uxbridge, UB8 3NN, United Kingdom
Related Publications (9)
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.
PMID: 38158159RESULTSheth 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: 41534798DERIVEDJaffe 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.
PMID: 40668667DERIVEDChakravarthy U, Chaudhary V, Sadda SR, Tan CS, Vujosevic S, Fauser S, Gibson K, Glittenberg C, Holekamp N, Lanza B, Maunz A, Willis JR, Singh RP. Effect of Faricimab versus Aflibercept on Hyperreflective Foci in Patients with Diabetic Macular Edema from the YOSEMITE/RHINE Trials. Ophthalmol Sci. 2025 Apr 19;5(5):100798. doi: 10.1016/j.xops.2025.100798. eCollection 2025 Sep-Oct.
PMID: 40496217DERIVEDGoldberg RA, Mar FA, Csaky K, Amador M, Khanani AM, Gibson K, Kolomeyer AM, Sim DA, Murata T, Wang T, Udaondo P, Souverain A, Shildkrot YE, Vujosevic S, Nudleman E, Sivaprasad S. Resolution of Angiographic Macular Leakage with Faricimab versus Aflibercept in Patients with Diabetic Macular Edema in YOSEMITE/RHINE. Ophthalmol Retina. 2025 Jun;9(6):515-526. doi: 10.1016/j.oret.2024.11.015. Epub 2024 Nov 22.
PMID: 39580145DERIVEDStockwell 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.
PMID: 37585454DERIVEDShimura 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.
PMID: 36897413DERIVEDEter 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.
PMID: 36246184DERIVEDWykoff 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.
PMID: 35085503DERIVED
MeSH Terms
Interventions
Limitations and Caveats
All secondary outcome measures were unpowered for statistical analysis, and the results should be interpreted with caution.
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
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2018
First Posted
August 9, 2018
Study Start
October 9, 2018
Primary Completion
October 19, 2020
Study Completion
May 31, 2023
Last Updated
July 11, 2025
Results First Posted
March 22, 2022
Record last verified: 2025-07
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