A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema

PHASE3CompletedINTERVENTIONAL
Enrollment

1,479

Participants

Timeline

Start Date

August 5, 2020

Primary Completion Date

October 11, 2023

Study Completion Date

October 11, 2023

Conditions
Diabetic Macular Edema
Interventions
DRUG

Faricimab

Faricimab will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen.

OTHER

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. The sham procedure will be administered to participants as appropriate during the first 16 weeks of this study in order to maintain the masking of the initial faricimab PTI.

Trial Locations (318)

27

Mácula D&T, Lima

TG Laser Oftalmica, Lima

333

Chang Gung Medical Foundation - Linkou; Ophthalmology, Taoyuan District

1068

Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Szemeszet, Budapest

1076

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

1085

Semmelweis Egyetem Szemészeti Vizsgálóhely, Budapest

1090

Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie, Vienna

1106

Bajcsy-Zsilinszky Hospital, Budapest

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

2000

Sydney Eye Hospital, Sydney

Sydney Retina Clinic and Day Surgery, Sydney

2135

Strathfield Retina Clinic, Strathfield

2145

Sydney West Retina, Westmead

3002

Centre For Eye Research Australia, East Melbourne

3178

Retina Specialists Victoria, Rowville

4000

Sjællands Universitetshospital, Roskilde; Øjenafdelingen, Roskilde

4021

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

4032

Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika, Debrecen

4102

Vista Klinik Ophthalmologische Klinik, Binningen

6009

The Lions Eye Institute, Nedlands

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

9000

Aalborg Universitetshospital; Øjenafdelingen, Aalborg

9700

Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET; Intezeti Gyogyszertar, Szombathely

10002

National Taiwan University Hospital; Ophthalmology, Zhongzheng Dist.

10017

New York University, New York

10330

King Chulalongkorn Memorial Hospital; Ophthalmology Department, Bangkok

10400

Rajavithi Hospital; Ophthalmology Department, Bangkok

11217

Taipei Veterans General Hospital; Ophthalmology, Taipei

11572

Ophthalmic Cons of Long Island, Oceanside

11788

Long Is. Vitreoretinal Consult, Hauppauge

11967

Island Retina, Shirley

12159

The Retina Consultants, Slingerlands

12206

Capital Region Retina, Albany

13088

Retina Vit Surgeons/Central NY, Liverpool

14620

Retina Associates of Western New York, Rochester

15706

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

16132

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

19107

Mid Atlantic Retina - Wills Eye Hospital, Philadelphia

Mid-Atlantic Retina, Philadelphia

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

21204

Retina Specialists, Towson

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

22903

Univ of Virginia Ophthalmology, Charlottesville

23235

Retina Institute of Virginia, Richmond

23502

Wagner Kapoor Institute, Norfolk

24502

Piedmont Eye Center, Lynchburg

26506

West Virginia University Eye Institute, Morgantown

27157

Wake Forest Baptist Health Eye Centre, Winston-Salem

28046

Clinica Baviera; Servicio Oftalmologia, Madrid

28210

Char Eye Ear &Throat Assoc, Charlotte

28222

Hospital Universitario Puerta de Hierro, Majadahonda

28602

Graystone Eye, Hickory

28803

Western Carolina Retinal Associate PA, Asheville

29169

Palmetto Retina Center, West Columbia

29456

Charleston Neuroscience Inst, Ladson

29605

Retina Consultants Of Carolina, Greenville

30625

Medizinische Hochschule Hannover, Klinik für Augenheilkunde, Hanover

30909

Southeast Retina Center, Augusta

31008

Clinica Universitaria de Navarra; Servicio de Oftalmologia, Pamplona

Complejo Hospitalario de Navarra; Servicio de oftalmologia, Pamplona

32308

Southern Vitreoretinal Assoc, Tallahassee

32503

Retina Specialty Institute, Pensacola

32901

Florida Eye Associates, Melbourne

33012

Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia, Oviedo

33064

Rand Eye, Deerfield Beach

33076

Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin, Bordeaux

33308

Retina Group of Florida, Fort Lauderdale

33324

Fort Lauderdale Eye Institute, Plantation

33410

Retina Care Specialists, Palm Beach Gardens

33609

Retina Associates of Florida, LLC, Tampa

33711

Retina Vitreous Assoc of FL, St. Petersburg

33912

National Ophthalmic Research Institute, Fort Myers

34421

Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology, Istanbul

35016

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

35100

Ege University Medical Faculty; Department of Ophthalmology, Izmir

37024

Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria; Presso Ufficio Cassa, Negrar Di Valpolicella (VR)

37203

Tennessee Retina PC, Nashville

37421

Southeastern Retina Associates Chattanooga, Chattanooga

37540

Centres Ophtalmologique St Exupéry; Ophtalmologie, Saint-Cyr-sur-Loire

38138

Charles Retina Institute, Germantown

39120

Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik, Magdeburg

40509

Retina Associates of Kentucky, Lexington

41380

Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology, Kocaeli

42130

Selcuk University Faculty of Medicine; Department Of Ophthalmology, Konya

43016

Midwest Retina, Dublin

43212

The Ohio State University Havener Eye Institute, Columbus

44093

CHU Nantes - Hôtel Dieu; Ophthalmology, Nantes

44122

Retina Assoc of Cleveland Inc, Cleveland

45242

Cincinnati Eye Institute, Cincinnati

46015

Fisabio-Ofalmologia Medica; Servicio de Oftalmología, Valencia

46100

Oftalvist Valencia, Burjassot

46290

Midwest Eye Institute, Indianapolis

47012

Hospital Universitario Rio Hortega; Servicio de Oftalmologia, Valladolid

48073

Assoc Retinal Consultants PC, Royal Oak

48145

Augenabteilung am St. Franziskus-Hospital, Münster

48149

Universitätsklinikum Münster; Augenheilkunde, Münster

49546

Associated Retinal Consultants, Grand Rapids

Foundation for Vision Research, Grand Rapids

Vitreo-Retinal Associates, Grand Rapids

49686

Associated Retinal Consultants, P.C., Traverse City

50134

Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica, Florence

50200

Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department, Chiang Mai

50266

Wolfe Eye Clinic, West Des Moines

53705

University of Wisconsin, Madison

55435

VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota, Edina

56124

Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria, Pisa

60452

University Retina and Macula Associates, PC, Oak Forest

62704

Prairie Eye & LASIK Center / Prairie Retina Center, Springfield

63017

Midwest Vision Research Foundation, Chesterfield

66215

Retina Associates, Lenexa

66424

Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde, Homburg/Saar

67214

Vitreo-Retinal Consultants, Wichita

69130

Pole Vision Val d'Ouest; Ophtalmologie, Écully

73013

Retina Vitreous Center, Edmond

75010

Hopital Lariboisiere; Ophtalmologie, Paris

75231

Texas Retina Associates, Dallas

75701

Eye Care Assoc of East Texas, Tyler

76087

Strategic Clinical Research Group, LLC, Willow Park

76092

Retina Center of Texas, Southlake

76180

Instituto de la retina del Bajio, Querétaro City

78240

Medical Center Ophthalmology Associates, San Antonio

78550

Valley Retina Institute P.A., Harlingen

78750

Austin Clinical Research LLC, Austin

79106

Universitätsklinikum Freiburg, Klinik für Augenheilkunde, Freiburg im Breisgau

79606

Retina Res Institute of Texas, Abilene

80045

University of Colorado; dept of ophthalmology, Aurora

80228

Colorado Retina Associates, PC, Lakewood

80336

LMU Klinikum der Universität, Augenklinik, München

80909

Retina Consultants of Southern, Colorado Springs

81675

Klinikum rechts der Isar der TU München; Augenklinik, München

84107

Retina Associates of Utah, PLLC, Salt Lake City

84132

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

85014

Retinal Research Institute, LLC, Phoenix

85016

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

90027

Southern California Permanente Medical Group, Los Angeles

90211

Retina-Vitreous Associates Medical Group, Beverly Hills

91107

California Eye Specialists Medical group Inc., Pasadena

91436

The Retina Partners, Encino

92064

Retina Consultants, San Diego, Poway

92211

Southern CA Desert Retina Cons, Palm Desert

92373

Retina Consultants of Southern California, Redlands

92705

Orange County Retina Med Group, Santa Ana

93103

California Retina Consultants, Santa Barbara

93309

California Retina Consultants., Bakersfield

93454

California Retina Consultants - Santa Maria, Santa Maria

93720

Eye Medical Center, Fresno

94010

Chi De Creteil; Ophtalmologie, Créteil

94040

Northern California Retina Vitreous Associates, Mountain View

94109

West Coast Retina Medical Group, San Francisco

94598

Bay Area Retina Associates, Walnut Creek

94609

East Bay Retina Consultants, Oakland

95008

Retinal Diagnostic Center, Campbell

95825

Retinal Consultants Med Group, Sacramento

96701

Retina Consultants of Hawaii, ‘Aiea

97080

Universitätsklinikum Würzburg, Augenklinik und Poliklinik, Würzburg

97221

Retina Northwest, Portland

119074

National University Hospital; Ophthalmology Department, Singapore

119435

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

124044

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

168751

Singapore Eye Research Institute, Singapore

308433

Tan Tock Seng Hospital; Ophthalmology Department, Singapore

420066

Clinics of Eye Diseases, LLC, Kazan'

428000

Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch, Cheboksary

450059

Clinic Optimed, Ufa

630096

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

664033

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

3109601

Rambam Medical Center; Opthalmology, Haifa

4941492

Rabin MC; Ophtalmology, Petah Tikva

6423906

Tel Aviv Sourasky MC; Ophtalmology, Tel Aviv

7660101

Kaplan Medical Center; Ophtalmology, Rehovot

9112001

Hadassah MC; Ophtalmology, Jerusalem

92835-3424

Retina Consultants of Orange County, Fullerton

06385

Retina Group of New England, Waterford

30060-1137

Georgia Retina PC, Marietta

04101

Maine Eye Center, Portland

02111

Tufts Medical Center; Ophthalmology, Boston

02114

Ophthalmic Consultants of Boston, Boston

02215

Beetham Eye Institute, Joslin Diabetes Center, Boston

01605

Vitreo-Retinal Associates, PC, Worcester

08820

NJRetina, Edison

08225

Retinal & Ophthalmic Cons PC, Northfield

07666

Retina Associates of NJ, Teaneck

44195-0001

Cleveland Clinic Foundation; Cole Eye Institute, Cleveland

78705-1169

Austin Retina Associates, Austin

77401-3510

Retina & Vitreous of Texas, Bellaire

77384-4167

Retina Consultants of Texas, The Woodlands

05405

Uni of Vermont Medical Center;, Burlington

C1017AAO

Fundacion Zambrano, CABA

C1120AAN

Oftalmos, Capital Federal

M5500GGK

Oftar, Mendoza

S2000ANJ

Centro Oftalmólogos Especialistas, Rosario

S2000DLA

Grupo Laser Vision, Rosario

C1015ABO

Organizacion Medica de Investigacion, San Nicolás

74980-010

Hospital de Olhos de Aparecida - HOA, Aparecida de Goiânia

74210-010

Centro Brasileiro de Cirurgia, Goiânia

90035-903

Hospital das Clinicas - UFRGS, Porto Alegre

89052-504

Botelho Hospital da Visao, Blumenau

09060-650

Faculdade de Medicina do ABC - FMABC, Santo André

04023-062

Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia, São Paulo

04084-002

CEMAPE - Centro Médico, São Paulo

05403-010

Hospital das Clinicas - FMUSP, São Paulo

18031-060

Hosp de Olhos de Sorocaba, Sorocaba

T2J 0C8

Calgary Retina Consultants, Calgary

B3H 2Y9

QEII - HSC Department of Ophthalmology, Halifax

N6A 4V2

Ivey Eye Institute, London

M3C 0G9

Toronto Retina Institute, Toronto

M5C 2T2

St. Michael's Hospital; Department of Ophthalmology, Toronto

M5T 2S9

University Health Network Toronto Western Hospital, Toronto

J7H 0E8

Institut De L'Oeil Des Laurentides, Boisbriand

500 05

FN Hradec Králové, O?ní klinika; Ophthalmology clinic, Hradec Králové

708 52

Faculty Hospital Ostrava; Ophthalmology clinic, Ostrava

100 34

Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic, Prague

Unknown

AXON Clinical, Prague

Queen Mary Hospital; Department of Ophthalmology, Hong Kong

Hong Kong Eye Hospital; CUHK Eye Centre, Mong Kok

356 01

Nemocnice Sokolov, Sokolov

01307

Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde, Dresden

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

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 Metropolitan University Hospital, Osaka

359-8513

National Defense Medical College Hospital, Saitama

520-2192

Shiga University Of Medical Science Hospital, Shiga

162-0054

Tokyo Women's Medical University, Tokyo

181-8611

Kyorin University Hospital, Tokyo

193-0998

Tokyo Medical University Hachioji Medical Center, Tokyo

06760

Centro Oftalmológico Mira, S.C, Del. Cuauhtemoc

01120

Macula Retina Consultores, Mexico City

04030

Hospital de la Ceguera APEC, Mexico City

Lima 33

Oftalmolaser, Lima

43-309

Szpital sw. Lukasza, Bielsko-Biala

85-316

Specjalistyczny O?rodek Okulistyczny Oculomedica, Bydgoszcz

85-631

OFTALMIKA Sp. z o.o, Bydgoszcz

41-902

Szpital Specjalistyczny nr 1; Oddzial Okulistyki, Bytom

80-402

Dobry Wzrok Sp Z O O, Gda?sk

80-809

Optimum Profesorskie Centrum Okulistyki, Gda?sk

44-100

Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT, Gliwice

40-594

Gabinet Okulistyczny Prof Edward Wylegala, Katowice

31-070

Centrum Medyczne UNO-MED, Krakow

31-501

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

44-203

Optomed Sp. z o.o., Rybnik

35-017

Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow, Rzeszów

35-055

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

42-600

Caminomed, Tarnowskie Góry

00-189

Centrum Zdrowia MDM, Warsaw

53-334

SPEKTRUM Osrodek Okulistyki Klinicznej, Wroclaw

4710-243

Hospital de Braga; Servico de Oftalmologia, Braga

3000-548

AIBILI - Association for Innovation and Biomedical Research on Light, Coimbra

3030-163

Espaco Medico Coimbra, Coimbra

1649-035

Hospital de Santa Maria; Servico de Oftalmologia, Lisbon

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

463-707

Seoul National University Bundang Hospital, Seongnam-si

02447

Kyung Hee University Hospital, Seoul

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08907

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat

08195

Hospital General de Catalunya, San Cugat Del Valles

02006

Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia, Albacete

03016

VISSUM Instituto Oftalmológico de Alicante, Alicante

08021

Centro de Oftalmologia Barraquer; Servicio Oftalmologia, Barcelona

08025

Hospital dos de maig; servicio de 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

06340

Ankara University Medical Faculty; Department of Ophthalmology, Ankara

06490

Ankara Baskent University Medical Faculty; Department of Ophthalmology, Ankara

BT12 6BA

Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL, Belfast

BD9 6RJ

Bradford Royal Infirmary, Bradford

CT1 3NG

East Kent Hospitals University NHS Foundation Trust, Canterbury

GU16 7UJ

Frimley Park Hospital, Frimley

GL1 3NN

Gloucestershire Hospitals NHS Foundation Trust, Gloucestershire

LS9 7TF

St James University Hospital, Leeds

L7 8YE

Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre, Liverpool

EC1V 2PD

Moorfields Eye Hospital NHS Foundation Trust, London

NW3 2QS

Royal Free Hospital, London

SW9 8RR

Kings College Hospital, London

M13 9WL

Manchester Royal Eye Hospital, Manchester

UB8 3NN

Hillingdon Hospital, Middx

NE1 4LP

Royal Victoria Infirmary, Newcastle upon Tyne

NR31 6LA

James Paget University Hospitals NHS Foundation Trust, Norfolk

SO16 6YD

University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit, Southampton

SR2 9HP

Sunderland Eye Infirmary, Sunderland

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04432831 - A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema | Biotech Hunter | Biotech Hunter