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

PHASE3CompletedINTERVENTIONAL
Enrollment

940

Participants

Timeline

Start Date

September 5, 2018

Primary Completion Date

October 20, 2020

Study Completion Date

September 3, 2021

Conditions
Diabetic Macular Edema
Interventions
DRUG

Aflibercept

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

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.

PROCEDURE

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.

Trial Locations (185)

27

Mácula D&T, Lima

Oftalmosalud Srl, Lima

TG Laser Oftalmica, Lima

1090

Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie, Vienna

1133

Budapest Retina Associates Kft., Budapest

1140

Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik, Vienna

1303

Medical Center for Eye Health - Focus Ltd, Sofia

1309

"Pentagram Eye Hospital (Medical Center Pentagram)", Sofia

1517

Spec. Ophth. Hospital for Active Treatment- Academic Pashev, Sofia

1784

Specialized Hospital for Active Treatment of Eye Diseases Zora, Sofia

4021

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

4032

Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika, Debrecen

6720

Szegedi Tudományegyetem ÁOK; Department of Ophtalmology, Szeged

7621

Ganglion Medial Center, Pécs

8036

LKH-Univ.Klinikum Graz; Universitäts-Augenklinik, Graz

8900

Zala Megyei Kórház; SZEMESZET, Zalaegerszeg

9002

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

9700

Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET, Szombathely

10021

MaculaCare, PLLC, New York

11021

Long Is. Vitreoretinal Consult, Great Neck

11967

Island Retina, Shirley

12206

Capital Region Retina, Albany

13008

Centre Paradis Monticelli; Ophtalmologie, Marseille

13088

Retina Vit Surgeons/Central NY, Liverpool

15706

Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia, Santiago de Compostela

16132

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

20100

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

20132

Irccs Ospedale San Raffaele;U.O. Oculistica, Milan

20815

Retina Group of Washington, Chevy Chase

21209

The Retina Care Center, Baltimore

21287

Johns Hopkins Med; Wilmer Eye Inst, Baltimore

21740

Cumberland Valley Retina PC, Hagerstown

22042

Emerson Clinical Research Institute, Falls Church

23502

Wagner Macula & Retina Center, Norfolk

24502

Piedmont Eye Center, Lynchburg

26506

West Virginia University Eye Institute, Morgantown

27157

Wake Forest Baptist Medical Center, Winston-Salem

28027

Clinica Universitaria de Navarra; Servicio de Oftalmologia, Madrid

28210

Char Eye Ear &Throat Assoc, Charlotte

28222

Hospital Universitario Puerta de Hierro, Majadahonda

28387

Carolina Eye Associates, Southern Pines

28602

Graystone Eye, Hickory

28803

Western Carolina Retinal Associate PA, Asheville

30060

Georgia Retina PC, Marietta

30625

Medizinische Hochschule Hannover, Klinik für Augenheilkunde, Hanover

31008

Clinica Universitaria de Navarra; Servicio de Oftalmologia, Pamplona

32308

Southern Vitreoretinal Assoc, Tallahassee

32503

Retina Specialty Institute, Pensacola

33000

Hopital Pellegrin; Ophtalmologie, Bordeaux

33064

Rand Eye, Deerfield Beach

33410

Retina Care Specialists, Palm Beach Gardens

33609

Retina Associates of Florida, LLC, Tampa

33612

University of South Florida, Tampa

35016

Hospital Universitario de Gran Canaria; Servicio de oftalmologia, Las Palmas de Gran Canaria

35100

Ege University Medical Faculty; Department of Ophthalmology, Izmir

37075

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

38119

Charles Retina Institute, Memphis

40509

Retina Associates of Kentucky, Lexington

42001

Paducah Retinal Center, Paducah

42130

Selcuk University Faculty of Medicine; Department Of Ophthalmology, Konya

43016

Midwest Retina, Dublin

43212

OSU Eye Physicians & Surgeons, Columbus

44093

CHU Nantes - Hôtel Dieu; Ophthalmology, Nantes

44122

Retina Assoc of Cleveland Inc, Cleveland

45242

Cincinnati Eye Institute, Cincinnati

46290

Midwest Eye Institute, Indianapolis

48073

Assoc Retinal Consultants PC, Royal Oak

48145

Augenabteilung am St. Franziskus-Hospital, Münster

48149

Universitätsklinikum Münster; Augenheilkunde, Münster

49546

Foundation for Vision Research, Grand Rapids

49686

Associated Retinal Consultants, P.C., Traverse City

50266

Wolfe Eye Clinic, West Des Moines

53127

Universitäts-Augenklinik Bonn, Bonn

53792

University of Wisconsin, Madison

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik, Mainz

55435

Vitreoretinal Surgery, Edina

57701

Black Hills Eye Institute, Rapid City

63017

Midwest Vision Research Foundation, Chesterfield

66100

Ospedale Clinicizzato SS Annunziata; Clinica Oftalmologica, Chieti

66215

Retina Associates, Lenexa

67214

Vitreo-Retinal Consultants, Wichita

69130

Pole Vision Val d'Ouest; Ophtalmologie, Écully

73013

Retina Vitreous Center, Edmond

75006

Centre Odeon; Exploration Ophtalmologique, Paris

75010

Hopital Lariboisiere; Ophtalmologie, Paris

75115

Retina Specialists, DeSoto

75231

Texas Retina Associates, Dallas

75701

Eye Care Assoc of East Texas, Tyler

76087

Strategic Clinical Research Group, LLC, Willow Park

76090

Instituto Mexicano de Oftalmologia I.A.P., Querétaro

77025

Retina & Vitreous of Texas, Houston

77401

Retina Consultants of Texas, Bellaire

78240

Med Center Ophthalmology Assoc, San Antonio

78550

Valley Retina Institute P.A., Harlingen

78750

Austin Clinical Research LLC, Austin

79606

Retina Res Institute of Texas, Abilene

80228

Colorado Retina Associates, PC, Lakewood

84107

Retina Associates of Utah, Salt Lake City

84132

University of Utah; Division of Gastroenterology/Hepatology, Salt Lake City

85021

Arizona Retina and Vitreous Consultants, Phoenix

85206

Barnet Dulaney Perkins Eye Center, Mesa

85704

Retina Associates Southwest PC, Tucson

87131

University of New Mexico, Albuquerque

89502

Sierra Eye Associates, Reno

91107

California Eye Specialists Medical group Inc., Pasadena

92064

Retina Consultants, San Diego, Poway

92211

Southern CA Desert Retina Cons, Palm Desert

92373

Retina Consultants of Southern California, Redlands

92505

Kaiser Permanente Riverside Medical Center, Riverside

92705

Orange County Retina Med Group, Santa Ana

93720

Eye Medical Center, Fresno

94107

W Coast Retina Med Group Inc, San Francisco

94609

East Bay Retina Consultants, Oakland

95008

Retinal Diagnostic Center, Campbell

95817

University of California, Davis, Eye Center, Sacramento

96701

Retina Consultants of Hawaii, ‘Aiea

97221

Retina Northwest, Portland

99204

Spokane Eye Clinical Research, Spokane

119435

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

194044

Medical Military Academy n.a S.M.Kirov, Saint Petersburg

450059

Clinic Optimed, Ufa

3109601

Rambam Medical Center; Opthalmology, Haifa

4941492

Rabin MC; Ophtalmology, Petah Tikva

6423906

Tel Aviv Sourasky MC; Ophtalmology, Tel Aviv

7610001

Kaplan Medical Center, Rehovot

9112001

Hadassah MC; Ophtalmology, Jerusalem

04101

Maine Eye Center, Portland

02114

Ophthalmic Consultants of Boston, Boston

02215

Beetham Eye Institute, Joslin Diabetes Center, Boston

01605

Vitreo-Retinal Associates, PC, Worcester

08034

Mid Atlantic Retina - Wills Eye Hospital, Cherry Hill

08820

NJ Retina, Edison

08225

Retinal & Ophthalmic Cons PC, Northfield

07666

Retina Associates of NJ, Teaneck

05401

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

00198

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

06129

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

460-0008

Sugita Eye Hospital, Aichi

466-8560

Nagoya University Hospital, Aichi

467-8602

Nagoya City University Hospital, Aichi

480-1195

Aichi Medical University Hospital, Aichi

285-8741

Toho University Sakura Medical Center, Chiba

812-0011

Hayashi Eye Hospital, Fukuoka

830-0011

Kurume University Hospital, Fukuoka

060-8648

Hokkaido University Hospital, Hokkaido

078-8510

Asahikawa Medical University Hospital, Hokkaido

660-8550

Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC), Hyōgo

310-0845

Kozawa eye hospital and diabetes center, Ibaraki

216-8511

St. Marianna University Hospital, Kanagawa

860-0027

Ideta Eye Hospital, Kumamoto

606-8507

Kyoto University Hospital, Kyoto

514-8507

Mie University Hospital, Mie

889-1692

University of Miyazaki Hospital, Miyazaki

634-8522

Nara Medical University Hospital, Nara

530-8480

Kitano Hospital, Osaka

545-8586

Osaka City University Hospital, Osaka

359-8513

National Defense Medical College Hospital, Saitama

520-2192

Shiga University Of Medical Science Hospital, Shiga

430-8558

Seirei Hamamatsu General Hospital, Shizuoka

770-8503

Tokushima University Hospital, Tokushima

162-8666

Tokyo Women's Medical University Hospital, Tokyo

181-8611

Kyorin University Hospital, Tokyo

193-0998

Tokyo Medical University Hachioji Medical Center, Tokyo

755-8505

Yamaguchi University Hospital, Yamaguchi

06760

Centro Oftalmológico Mira, S.C, Cuauhtémoc

01120

Macula Retina Consultores, México

04030

Hospital de la Ceguera APEC, México

Lima 33

Oftalmolaser, Lima

43-309

Szpital sw. Lukasza, Bielsko-Biala

41-902

Szpital Specjalistyczny nr 1; Oddzial Okulistyki, Bytom

80-402

Dobry Wzrok Sp Z O O, Gdansk

40-594

Gabinet Okulistyczny Prof Edward Wylegala, Katowice

31-070

Centrum Medyczne UNO-MED, Krakow

44-203

Optomed Sp. z o.o., Rybnik

35-055

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

53-334

SPEKTRUM Osrodek Okulistyki Klinicznej, Wroclaw

075 01

Nemocnica s poliklinikou Trebišov, a.s., Trebišov

911 71

Fakultna nemocnica Trencin Ocna klinika, Trenčín

012 07

Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie, Žilina

02006

Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia, Albacete

03016

VISSUM Instituto Oftalmológico de Alicante, Alicante

08021

Centro de Oftalmologia Barraquer; Servicio Oftalmologia, Barcelona

08028

Hospital Clinic de Barcelona; Consultas Externas Oftalmologia, Barcelona

08041

Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia, Barcelona

06100

Hacettepe University Medical Faculty; Department of Ophthalmology, Ankara

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03622580 - A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE) | Biotech Hunter | Biotech Hunter