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

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

940 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-05

Study Completion Date

2021-09-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Macular Edema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 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.

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 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.

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 clinic visits to maintain masking among treatment arms.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 clinic visits to maintain masking among treatment arms.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Eylea VABYSMO™ RO6867461 RG7716

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Barnet Dulaney Perkins Eye Center

Mesa, Arizona, United States

Site Status

Arizona Retina and Vitreous Consultants

Phoenix, Arizona, United States

Site Status

Retina Associates Southwest PC

Tucson, Arizona, United States

Site Status

Retinal Diagnostic Center

Campbell, California, United States

Site Status

Eye Medical Center

Fresno, California, United States

Site Status

East Bay Retina Consultants

Oakland, California, United States

Site Status

Southern CA Desert Retina Cons

Palm Desert, California, United States

Site Status

California Eye Specialists Medical group Inc.

Pasadena, California, United States

Site Status

Retina Consultants, San Diego

Poway, California, United States

Site Status

Retina Consultants of Southern California

Redlands, California, United States

Site Status

Kaiser Permanente Riverside Medical Center

Riverside, California, United States

Site Status

University of California, Davis, Eye Center

Sacramento, California, United States

Site Status

W Coast Retina Med Group Inc

San Francisco, California, United States

Site Status

Orange County Retina Med Group

Santa Ana, California, United States

Site Status

Colorado Retina Associates, PC

Lakewood, Colorado, United States

Site Status

Rand Eye

Deerfield Beach, Florida, United States

Site Status

Retina Care Specialists

Palm Beach Gardens, Florida, United States

Site Status

Retina Specialty Institute

Pensacola, Florida, United States

Site Status

Southern Vitreoretinal Assoc

Tallahassee, Florida, United States

Site Status

Retina Associates of Florida, LLC

Tampa, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Georgia Retina PC

Marietta, Georgia, United States

Site Status

Retina Consultants of Hawaii

‘Aiea, Hawaii, United States

Site Status

Midwest Eye Institute

Indianapolis, Indiana, United States

Site Status

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Site Status

Retina Associates

Lenexa, Kansas, United States

Site Status

Vitreo-Retinal Consultants

Wichita, Kansas, United States

Site Status

Retina Associates of Kentucky

Lexington, Kentucky, United States

Site Status

Paducah Retinal Center

Paducah, Kentucky, United States

Site Status

Maine Eye Center

Portland, Maine, United States

Site Status

The Retina Care Center

Baltimore, Maryland, United States

Site Status

Johns Hopkins Med; Wilmer Eye Inst

Baltimore, Maryland, United States

Site Status

Retina Group of Washington

Chevy Chase, Maryland, United States

Site Status

Cumberland Valley Retina PC

Hagerstown, Maryland, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

Beetham Eye Institute, Joslin Diabetes Center

Boston, Massachusetts, United States

Site Status

Vitreo-Retinal Associates, PC

Worcester, Massachusetts, United States

Site Status

Foundation for Vision Research

Grand Rapids, Michigan, United States

Site Status

Assoc Retinal Consultants PC

Royal Oak, Michigan, United States

Site Status

Associated Retinal Consultants, P.C.

Traverse City, Michigan, United States

Site Status

Vitreoretinal Surgery

Edina, Minnesota, United States

Site Status

Midwest Vision Research Foundation

Chesterfield, Missouri, United States

Site Status

Sierra Eye Associates

Reno, Nevada, United States

Site Status

Mid Atlantic Retina - Wills Eye Hospital

Cherry Hill, New Jersey, United States

Site Status

NJ Retina

Edison, New Jersey, United States

Site Status

Retinal & Ophthalmic Cons PC

Northfield, New Jersey, United States

Site Status

Retina Associates of NJ

Teaneck, New Jersey, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Capital Region Retina

Albany, New York, United States

Site Status

Long Is. Vitreoretinal Consult

Great Neck, New York, United States

Site Status

Retina Vit Surgeons/Central NY

Liverpool, New York, United States

Site Status

MaculaCare, PLLC

New York, New York, United States

Site Status

Island Retina

Shirley, New York, United States

Site Status

Western Carolina Retinal Associate PA

Asheville, North Carolina, United States

Site Status

Char Eye Ear &Throat Assoc

Charlotte, North Carolina, United States

Site Status

Graystone Eye

Hickory, North Carolina, United States

Site Status

Carolina Eye Associates

Southern Pines, North Carolina, United States

Site Status

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Site Status

Retina Assoc of Cleveland Inc

Cleveland, Ohio, United States

Site Status

OSU Eye Physicians & Surgeons

Columbus, Ohio, United States

Site Status

Midwest Retina

Dublin, Ohio, United States

Site Status

Retina Vitreous Center

Edmond, Oklahoma, United States

Site Status

Retina Northwest

Portland, Oregon, United States

Site Status

Black Hills Eye Institute

Rapid City, South Dakota, United States

Site Status

Charles Retina Institute

Memphis, Tennessee, United States

Site Status

Retina Res Institute of Texas

Abilene, Texas, United States

Site Status

Austin Clinical Research LLC

Austin, Texas, United States

Site Status

Retina Consultants of Texas

Bellaire, Texas, United States

Site Status

Texas Retina Associates

Dallas, Texas, United States

Site Status

Retina Specialists

DeSoto, Texas, United States

Site Status

Valley Retina Institute P.A.

Harlingen, Texas, United States

Site Status

Retina & Vitreous of Texas

Houston, Texas, United States

Site Status

Med Center Ophthalmology Assoc

San Antonio, Texas, United States

Site Status

Eye Care Assoc of East Texas

Tyler, Texas, United States

Site Status

Strategic Clinical Research Group, LLC

Willow Park, Texas, United States

Site Status

Retina Associates of Utah

Salt Lake City, Utah, United States

Site Status

University of Utah; Division of Gastroenterology/Hepatology

Salt Lake City, Utah, United States

Site Status

University of Vermont Medical Center; Investigational Drug Service, Pharmacy Department/Baird 1

Burlington, Vermont, United States

Site Status

Emerson Clinical Research Institute

Falls Church, Virginia, United States

Site Status

Piedmont Eye Center

Lynchburg, Virginia, United States

Site Status

Wagner Macula & Retina Center

Norfolk, Virginia, United States

Site Status

Spokane Eye Clinical Research

Spokane, Washington, United States

Site Status

West Virginia University Eye Institute

Morgantown, West Virginia, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

LKH-Univ.Klinikum Graz; Universitäts-Augenklinik

Graz, , Austria

Site Status

Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde

Linz, , Austria

Site Status

Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

Vienna, , Austria

Site Status

Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik

Vienna, , Austria

Site Status

Medical Center for Eye Health - Focus Ltd

Sofia, , Bulgaria

Site Status

Pentagram Eye Hospital (Medical Center "Pentagram")

Sofia, , Bulgaria

Site Status

Spec. Ophth. Hospital for Active Treatment- Academic Pashev

Sofia, , Bulgaria

Site Status

Specialized Hospital for Active Treatment of Eye Diseases Zora

Sofia, , Bulgaria

Site Status

Ambulatory - Medical Center for Specialized Medical Assistance - "Eye Clinic Sveta Petka" Ltd

Varna, , Bulgaria

Site Status

Hopital Pellegrin; Ophtalmologie

Bordeaux, , France

Site Status

Pole Vision Val d'Ouest; Ophtalmologie

Écully, , France

Site Status

Centre Paradis Monticelli; Ophtalmologie

Marseille, , France

Site Status

CHU Nantes - Hôtel Dieu; Ophthalmology

Nantes, , France

Site Status

Centre Odeon; Exploration Ophtalmologique

Paris, , France

Site Status

Hopital Lariboisiere; Ophtalmologie

Paris, , France

Site Status

Universitäts-Augenklinik Bonn

Bonn, , Germany

Site Status

Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde 3.B1.266

Göttingen, , Germany

Site Status

Medizinische Hochschule Hannover, Klinik für Augenheilkunde

Hanover, , Germany

Site Status

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik

Mainz, , Germany

Site Status

Augenabteilung am St. Franziskus-Hospital

Münster, , Germany

Site Status

Universitätsklinikum Münster; Augenheilkunde

Münster, , Germany

Site Status

Budapest Retina Associates Kft.

Budapest, , Hungary

Site Status

Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

Debrecen, , Hungary

Site Status

Ganglion Medial Center

Pécs, , Hungary

Site Status

Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

Szeged, , Hungary

Site Status

Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET

Szombathely, , Hungary

Site Status

Zala Megyei Kórház; SZEMESZET

Zalaegerszeg, , Hungary

Site Status

Rambam Medical Center; Opthalmology

Haifa, , Israel

Site Status

Hadassah MC; Ophtalmology

Jerusalem, , Israel

Site Status

Rabin MC; Ophtalmology

Petah Tikva, , Israel

Site Status

Kaplan Medical Center

Rehovot, , Israel

Site Status

Tel Aviv Sourasky MC; Ophtalmology

Tel Aviv, , Israel

Site Status

Ospedale Clinicizzato SS Annunziata; Clinica Oftalmologica

Chieti, Abruzzo, Italy

Site Status

Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

Rome, Lazio, Italy

Site Status

UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

Genoa, Liguria, Italy

Site Status

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

Milan, Lombardy, Italy

Site Status

Irccs Ospedale San Raffaele;U.O. Oculistica

Milan, Lombardy, Italy

Site Status

Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica

Perugia, Umbria, Italy

Site Status

Sugita Eye Hospital

Aichi, , Japan

Site Status

Nagoya University Hospital

Aichi, , Japan

Site Status

Nagoya City University Hospital

Aichi, , Japan

Site Status

Aichi Medical University Hospital

Aichi, , Japan

Site Status

Toho University Sakura Medical Center

Chiba, , Japan

Site Status

Hayashi Eye Hospital

Fukuoka, , Japan

Site Status

Kurume University Hospital

Fukuoka, , Japan

Site Status

Hokkaido University Hospital

Hokkaido, , Japan

Site Status

Asahikawa Medical University Hospital

Hokkaido, , Japan

Site Status

Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

Hyōgo, , Japan

Site Status

Kozawa eye hospital and diabetes center

Ibaraki, , Japan

Site Status

St. Marianna University Hospital

Kanagawa, , Japan

Site Status

Ideta Eye Hospital

Kumamoto, , Japan

Site Status

Kyoto University Hospital

Kyoto, , Japan

Site Status

Mie University Hospital

Mie, , Japan

Site Status

University of Miyazaki Hospital

Miyazaki, , Japan

Site Status

Nara Medical University Hospital

Nara, , Japan

Site Status

Kitano Hospital

Osaka, , Japan

Site Status

Osaka City University Hospital

Osaka, , Japan

Site Status

National Defense Medical College Hospital

Saitama, , Japan

Site Status

Shiga University Of Medical Science Hospital

Shiga, , Japan

Site Status

Seirei Hamamatsu General Hospital

Shizuoka, , Japan

Site Status

Tokushima University Hospital

Tokushima, , Japan

Site Status

Tokyo Women's Medical University Hospital

Tokyo, , Japan

Site Status

Kyorin University Hospital

Tokyo, , Japan

Site Status

Tokyo Medical University Hachioji Medical Center

Tokyo, , Japan

Site Status

Yamaguchi University Hospital

Yamaguchi, , Japan

Site Status

Centro Oftalmológico Mira, S.C

Cuauhtémoc, Mexico CITY (federal District), Mexico

Site Status

Macula Retina Consultores

México, , Mexico

Site Status

Hospital de la Ceguera APEC

México, , Mexico

Site Status

Instituto Mexicano de Oftalmologia I.A.P.

Querétaro, , Mexico

Site Status

Mácula D&T

Lima, , Peru

Site Status

Oftalmosalud Srl

Lima, , Peru

Site Status

TG Laser Oftalmica

Lima, , Peru

Site Status

Oftalmolaser

Lima, , Peru

Site Status

Szpital sw. Lukasza

Bielsko-Biala, , Poland

Site Status

Szpital Specjalistyczny nr 1; Oddzial Okulistyki

Bytom, , Poland

Site Status

Dobry Wzrok Sp Z O O

Gdansk, , Poland

Site Status

Gabinet Okulistyczny Prof Edward Wylegala

Katowice, , Poland

Site Status

Centrum Medyczne UNO-MED

Krakow, , Poland

Site Status

Optomed Sp. z o.o.

Rybnik, , Poland

Site Status

Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina; Klinika Okulistyki

Rzeszów, , Poland

Site Status

SPEKTRUM Osrodek Okulistyki Klinicznej

Wroclaw, , Poland

Site Status

Clinic Optimed

Ufa, Bashkortostan Republic, Russia

Site Status

FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences

Moscow, , Russia

Site Status

Medical Military Academy n.a S.M.Kirov

Saint Petersburg, , Russia

Site Status

Nemocnica s poliklinikou Trebišov, a.s.

Trebišov, , Slovakia

Site Status

Fakultna nemocnica Trencin Ocna klinika

Trenčín, , Slovakia

Site Status

Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

Žilina, , Slovakia

Site Status

Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia

Santiago de Compostela, LA Coruña, Spain

Site Status

Hospital Universitario de Gran Canaria; Servicio de oftalmologia

Las Palmas de Gran Canaria, LAS Palmas, Spain

Site Status

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status

Clinica Universitaria de Navarra; Servicio de Oftalmologia

Pamplona, Navarre, Spain

Site Status

Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia

Albacete, , Spain

Site Status

VISSUM Instituto Oftalmológico de Alicante

Alicante, , Spain

Site Status

Centro de Oftalmologia Barraquer; Servicio Oftalmologia

Barcelona, , Spain

Site Status

Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

Barcelona, , Spain

Site Status

Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia

Barcelona, , Spain

Site Status

Clinica Universitaria de Navarra; Servicio de Oftalmologia

Madrid, , Spain

Site Status

Hacettepe University Medical Faculty; Department of Ophthalmology

Ankara, , Turkey (Türkiye)

Site Status

Ege University Medical Faculty; Department of Ophthalmology

Izmir, , Turkey (Türkiye)

Site Status

Selcuk University Faculty of Medicine; Department Of Ophthalmology

Konya, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Austria Bulgaria France Germany Hungary Israel Italy Japan Mexico Peru Poland Russia Slovakia Spain Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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)

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.

Reference Type DERIVED
PMID: 37955955 (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

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-005104-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GR40349

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of IBI302 Injection in nAMD or DME
NCT05961007 SUSPENDED PHASE1/PHASE2