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

NCT ID: NCT03622593

Last Updated: 2025-07-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

951 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-09

Study Completion Date

2023-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Group Type EXPERIMENTAL

Faricimab

Intervention Type DRUG

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

Intervention Type 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 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 up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.

Group Type EXPERIMENTAL

Faricimab

Intervention Type DRUG

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

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Aflibercept

Intervention Type DRUG

Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).

Sham Procedure

Intervention Type 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 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).

Intervention Type DRUG

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.

Intervention Type DRUG

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 visits to maintain masking among treatment arms.

Intervention Type PROCEDURE

Other Intervention Names

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Eylea VABYSMO™ RO6867461 RG7716

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Associated Retina Consultants

Phoenix, Arizona, United States

Site Status

Retinal Research Institute, LLC

Phoenix, Arizona, United States

Site Status

Northwest Arkansas Retina Associates

Springdale, Arkansas, United States

Site Status

California Retina Consultants

Bakersfield, California, United States

Site Status

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Site Status

The Retina Partners

Encino, California, United States

Site Status

Retina Consultants of Orange County

Fullerton, California, United States

Site Status

Northern California Retina Vitreous Associates

Mountain View, California, United States

Site Status

Retinal Consultants Med Group

Sacramento, California, United States

Site Status

California Retina Consultants

Santa Barbara, California, United States

Site Status

California Retina Consultants

Santa Maria, California, United States

Site Status

Bay Area Retina Associates

Walnut Creek, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

Retina Consultants of Southern

Colorado Springs, Colorado, United States

Site Status

Retina Group of New England

Waterford, Connecticut, United States

Site Status

Retina Group of Florida

Fort Lauderdale, Florida, United States

Site Status

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Site Status

Florida Eye Associates

Melbourne, Florida, United States

Site Status

Bascom Palmer Eye Institute

Palm Beach Gardens, Florida, United States

Site Status

Fort Lauderdale Eye Institute

Plantation, Florida, United States

Site Status

Retina Vitreous Assoc of FL

St. Petersburg, Florida, United States

Site Status

Southeast Retina Center

Augusta, Georgia, United States

Site Status

University Retina and Macula Associates, PC

Oak Forest, Illinois, United States

Site Status

Prairie Retina Center

Springfield, Illinois, United States

Site Status

Retina Specialists

Baltimore, Maryland, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Associated Retinal Consultants

Grand Rapids, Michigan, United States

Site Status

Vitreo-Retinal Associates

Grand Rapids, Michigan, United States

Site Status

Retina Consultants of Nevada

Las Vegas, Nevada, United States

Site Status

Envision Ocular, LLC

Bloomfield, New Jersey, United States

Site Status

Long Is. Vitreoretinal Consult

Hauppauge, New York, United States

Site Status

New York University

New York, New York, United States

Site Status

Ophthalmic Cons of Long Island

Oceanside, New York, United States

Site Status

Retina Assoc of Western NY

Rochester, New York, United States

Site Status

University of Rochester Flaum Eye Institute

Rochester, New York, United States

Site Status

The Retina Consultants

Slingerlands, New York, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Mid Atlantic Retina - Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Site Status

Retina Consultants Of Carolina

Greenville, South Carolina, United States

Site Status

Charleston Neuroscience Inst

Ladson, South Carolina, United States

Site Status

Palmetto Retina Center

West Columbia, South Carolina, United States

Site Status

Southeastern Retina Associates Chattanooga

Chattanooga, Tennessee, United States

Site Status

Southeastern Retina Associates

Knoxville, Tennessee, United States

Site Status

Tennessee Retina PC

Nashville, Tennessee, United States

Site Status

Austin Retina Associates

Austin, Texas, United States

Site Status

Retina Consultants of Texas

Bellaire, Texas, United States

Site Status

Retina Center of Texas

Southlake, Texas, United States

Site Status

Univ of Virginia Ophthalmology

Charlottesville, Virginia, United States

Site Status

Retina Institute of Virginia

Richmond, Virginia, United States

Site Status

Pacific Northwest Retina

Silverdale, Washington, United States

Site Status

Organizacion Medica de Investigacion

Buenos Aires, , Argentina

Site Status

Fundacion Zambrano

CABA, , Argentina

Site Status

Oftalmos

Capital Federal, , Argentina

Site Status

Oftar

Mendoza, , Argentina

Site Status

Centro Oftalmólogos Especialistas

Rosario, , Argentina

Site Status

Grupo Laser Vision

Rosario, , Argentina

Site Status

Strathfield Retina Clinic

Strathfield, New South Wales, Australia

Site Status

Sydney Eye Hospital

Sydney, New South Wales, Australia

Site Status

Sydney Retina Clinic and Day Surgery

Sydney, New South Wales, Australia

Site Status

Sydney West Retina

Westmead, New South Wales, Australia

Site Status

Centre For Eye Research Australia

East Melbourne, Victoria, Australia

Site Status

Retina Specialists Victoria

Rowville, Victoria, Australia

Site Status

The Lions Eye Institute

Nedlands, Western Australia, Australia

Site Status

Hospital de Olhos de Aparecida - HOA

Aparecida de Goiânia, Goiás, Brazil

Site Status

Centro Brasileiro de Cirurgia

Goiânia, Goiás, Brazil

Site Status

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Botelho Hospital da Visao

Blumenau, Santa Catarina, Brazil

Site Status

Faculdade de Medicina do ABC - FMABC

Santo André, São Paulo, Brazil

Site Status

Universidade Federal de Sao Paulo - UNIFESP*X

São Paulo, São Paulo, Brazil

Site Status

CEMAPE - Centro Médico

São Paulo, São Paulo, Brazil

Site Status

Hospital das Clinicas - FMUSP

São Paulo, São Paulo, Brazil

Site Status

Hosp de Olhos de Sorocaba

Sorocaba, São Paulo, Brazil

Site Status

Calgary Retina Consultants

Calgary, Alberta, Canada

Site Status

University of British Columbia - Vancouver Coastal Health Authority

Vancouver, British Columbia, Canada

Site Status

QEII - HSC Department of Ophthalmology

Halifax, Nova Scotia, Canada

Site Status

Ivey Eye Institute

London, Ontario, Canada

Site Status

University of Ottawa Eye Institute

Ottawa, Ontario, Canada

Site Status

Toronto Retina Institute

Toronto, Ontario, Canada

Site Status

Unity Health Toronto

Toronto, Ontario, Canada

Site Status

University Health Network Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Institut De L'Oeil Des Laurentides

Boisbriand, Quebec, Canada

Site Status

Hôpital Maisonneuve - Rosemont

Montreal, Quebec, Canada

Site Status

Beijing Friendship Hospital

Beijing, , China

Site Status

Beijing Tongren Hospital

Beijing, , China

Site Status

Peking Union Medical College Hospital

Beijing, , China

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The Second Hospital of Jilin University

Changchun, , China

Site Status

West China Hospital, Sichuan University

Chengdu, , China

Site Status

Southwest Hospital , Third Military Medical University

Chongqing, , China

Site Status

Army Medical Center of PLA(Daping Hospital)

Chongqing, , China

Site Status

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, , China

Site Status

The Affiliated Eye Hospital of Nanjing Medical University

Nanjing, , China

Site Status

Shanghai Tenth People's Hospital

Shanghai, , China

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Shanghai First People's Hospital

Shanghai, , China

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Tianjin Eye Hospital

Tianjin, , China

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Tianjin Medical University Eye Hospital

Tianjin, , China

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Eye Hospital, Wenzhou Medical University

Wenzhou, , China

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Wuxi No.2 People's Hospital

Wuxi, , China

Site Status

FN Hradec Králové, O?ní klinika

Hradec Králové, , Czechia

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Faculty Hospital Ostrava

Ostrava, , Czechia

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Faculty Hospital Kralovske Vinohrady

Prague, , Czechia

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AXON Clinical

Prague, , Czechia

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Nemocnice Sokolov

Sokolov, , Czechia

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Aalborg Universitetshospital

Aalborg, , Denmark

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Rigshospitalet Glostrup

Glostrup Municipality, , Denmark

Site Status

Sjællands Universitetshospital, Roskilde

Roskilde, , Denmark

Site Status

Chi De Creteil

Créteil, , France

Site Status

Centre Ophtalmologique

Paris, , France

Site Status

Centres Ophtalmologique St Exupéry

Saint-Cyr-sur-Loire, , France

Site Status

Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde

Dresden, , Germany

Site Status

Universitätsklinikum Freiburg, Klinik für Augenheilkunde

Freiburg im Breisgau, , Germany

Site Status

Universitätsklinikum des Saarlandes

Homburg/Saar, , Germany

Site Status

Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik

Magdeburg, , Germany

Site Status

LMU Klinikum der Universität, Augenklinik

München, , Germany

Site Status

Klinikum rechts der Isar der TU München

München, , Germany

Site Status

Universitätsklinikum Würzburg, Augenklinik und Poliklinik

Würzburg, , Germany

Site Status

The University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Hong Kong Eye Hospital

Mong Kok, , Hong Kong

Site Status

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, , Hungary

Site Status

Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

Budapest, , Hungary

Site Status

Semmelweis Egyetem Szemészeti Vizsgálóhely

Budapest, , Hungary

Site Status

Bajcsy-Zsilinszky Hospital

Budapest, , Hungary

Site Status

Fondazione Ptv Policlinico Tor Vergata Di Roma

Rome, Lazio, Italy

Site Status

Azienda Ospedaliero-Universitaria Careggi

Florence, Tuscany, Italy

Site Status

Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello

Pisa, Tuscany, Italy

Site Status

Ospedale Classificato Equiparato Sacro Cuore Don Calabria

Negrar, Veneto, Italy

Site Status

A.O. Universitaria S. Maria Della Misericordia Di Udine

Udine, Veneto, Italy

Site Status

OFTALMIKA Sp. z o.o

Bydgoszcz, , Poland

Site Status

Specjalistyczny O?rodek Okulistyczny Oculomedica

Bydgoszcz, , Poland

Site Status

Optimum Profesorskie Centrum Okulistyki

Gdansk, , Poland

Site Status

Niepubliczny Zaklad Opieki Zdrowotnej PRYZMAT-OKULISTYKA

Gliwice, , Poland

Site Status

SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej

Krakow, , Poland

Site Status

Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow

Rzeszów, , Poland

Site Status

Caminomed

Tarnowskie Góry, , Poland

Site Status

Centrum Zdrowia MDM

Warsaw, , Poland

Site Status

Hospital de Braga

Braga, , Portugal

Site Status

AIBILI - Association for Innovation and Biomedical Research on Light

Coimbra, , Portugal

Site Status

Espaco Medico Coimbra

Coimbra, , Portugal

Site Status

Hospital de Santa Maria

Lisbon, , Portugal

Site Status

Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov

Cheboksary, Mariy-El Republic, Russia

Site Status

Clinics of Eye Diseases, LLC

Kazan', Tatarstan Republic, Russia

Site Status

?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch

Irkutsk, , Russia

Site Status

?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch

Novosibirsk, , Russia

Site Status

National University Hospital

Singapore, , Singapore

Site Status

Singapore Eye Research Institute

Singapore, , Singapore

Site Status

Tan Tock Seng Hospital

Singapore, , Singapore

Site Status

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Site Status

Kyung Hee University Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Asan Medical Center.

Seoul, , South Korea

Site Status

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Site Status

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Site Status

Instituto Oftalmologico Fernandez Vega

Oviedo, Principality of Asturias, Spain

Site Status

Oftalvist Valencia

Burjassot, Valencia, Spain

Site Status

Hospital dos de maig

Barcelona, , Spain

Site Status

Clinica Baviera

Madrid, , Spain

Site Status

Fisabio-Ofalmologia Medica

Valencia, , Spain

Site Status

Hospital Universitario Rio Hortega

Valladolid, , Spain

Site Status

Vista Klinik Ophthalmologische Klinik

Binningen, , Switzerland

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Chang Gung Medical Foundation - Linkou

Taoyuan District, , Taiwan

Site Status

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status

Rajavithi Hospital

Bangkok, , Thailand

Site Status

Maharaj Nakorn ChiangMai Hospital

Chiang Mai, , Thailand

Site Status

Ankara University Medical Faculty; Department of Ophthalmology

Ankara, , Turkey (Türkiye)

Site Status

Ankara Baskent University Medical Faculty; Department of Ophthalmology

Ankara, , Turkey (Türkiye)

Site Status

Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology

Istanbul, , Turkey (Türkiye)

Site Status

Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology

Kocaeli, , Turkey (Türkiye)

Site Status

Barnet Hospital

Barnet, , United Kingdom

Site Status

Bradford Royal Infirmary

Bradford, , United Kingdom

Site Status

University Hospitals Bristol NHS Foundation Trust, Bristol Eye Hospital

Bristol, , United Kingdom

Site Status

Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

Bristol, , United Kingdom

Site Status

East Kent Hospitals University NHS Foundation Trust

Canterbury, , United Kingdom

Site Status

Frimley Park Hospital

Frimley, , United Kingdom

Site Status

Gloucestershire Hospitals NHS Foundation Trust

Gloucester, , United Kingdom

Site Status

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, , United Kingdom

Site Status

St James University Hospital

Leeds, , United Kingdom

Site Status

Royal Liverpool University Hospital

Liverpool, , United Kingdom

Site Status

Moorfields Eye Hospital NHS Foundation Trust

London, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Kings College Hospital

London, , United Kingdom

Site Status

Manchester Royal Eye Hospital

Manchester, , United Kingdom

Site Status

Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

Site Status

University Hospital Southampton NHS Foundation Trust

Southampton, , United Kingdom

Site Status

Sunderland Eye Infirmary

Sunderland, , United Kingdom

Site Status

Hillingdon Hospital

Uxbridge, , United Kingdom

Site Status

Countries

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United States Argentina Australia Brazil Canada China Czechia Denmark France Germany Hong Kong Hungary Italy Poland Portugal Russia Singapore South Korea Spain Switzerland Taiwan Thailand Turkey (Türkiye) United Kingdom

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.

Reference Type RESULT
PMID: 38158159 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40668667 (View on PubMed)

Chakravarthy 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.

Reference Type DERIVED
PMID: 40496217 (View on PubMed)

Goldberg 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.

Reference Type DERIVED
PMID: 39580145 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37585454 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36897413 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36246184 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35085503 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017-005105-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GR40398

Identifier Type: -

Identifier Source: org_study_id

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