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

PHASE3CompletedINTERVENTIONAL
Enrollment

951

Participants

Timeline

Start Date

October 9, 2018

Primary Completion Date

October 19, 2020

Study Completion Date

May 31, 2023

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 visits to maintain masking among treatment arms.

Trial Locations (188)

333

Chang Gung Medical Foundation - Linkou, Taoyuan District

1023

Fundacion Zambrano, CABA

1068

Magyar Honvedseg Egeszsegugyi Kozpont, Budapest

1076

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

1085

Semmelweis Egyetem Szemészeti Vizsgálóhely, Budapest

1106

Bajcsy-Zsilinszky Hospital, Budapest

2000

Sydney Eye Hospital, Sydney

Sydney Retina Clinic and Day Surgery, Sydney

2135

Strathfield Retina Clinic, Strathfield

2145

Sydney West Retina, Westmead

2600

Rigshospitalet Glostrup, Glostrup Municipality

3002

Centre For Eye Research Australia, East Melbourne

3178

Retina Specialists Victoria, Rowville

4000

Sjællands Universitetshospital, Roskilde, Roskilde

4102

Vista Klinik Ophthalmologische Klinik, Binningen

6009

The Lions Eye Institute, Nedlands

9000

Aalborg Universitetshospital, Aalborg

10002

National Taiwan University Hospital, Taipei

10017

New York University, New York

10330

King Chulalongkorn Memorial Hospital, Bangkok

10400

Rajavithi Hospital, Bangkok

11217

Taipei Veterans General Hospital, Taipei

11572

Ophthalmic Cons of Long Island, Oceanside

11788

Long Is. Vitreoretinal Consult, Hauppauge

12159

The Retina Consultants, Slingerlands

13620

Seoul National University Bundang Hospital, Gyeonggi-do

14620

Retina Assoc of Western NY, Rochester

14642

University of Rochester Flaum Eye Institute, Rochester

19107

Mid Atlantic Retina - Wills Eye Hospital, Philadelphia

21204

Retina Specialists, Baltimore

22903

Univ of Virginia Ophthalmology, Charlottesville

23235

Retina Institute of Virginia, Richmond

28046

Clinica Baviera, Madrid

29169

Palmetto Retina Center, West Columbia

29456

Charleston Neuroscience Inst, Ladson

29605

Retina Consultants Of Carolina, Greenville

30909

Southeast Retina Center, Augusta

31008

Complejo Hospitalario de Navarra, Pamplona

32901

Florida Eye Associates, Melbourne

33012

Instituto Oftalmologico Fernandez Vega, Oviedo

33100

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

33308

Retina Group of Florida, Fort Lauderdale

33324

Fort Lauderdale Eye Institute, Plantation

33418

Bascom Palmer Eye Institute, Palm Beach Gardens

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

37024

Ospedale Classificato Equiparato Sacro Cuore Don Calabria, Negrar

37203

Tennessee Retina PC, Nashville

37421

Southeastern Retina Associates Chattanooga, Chattanooga

37540

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

37922

Southeastern Retina Associates, Knoxville

39120

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

41380

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

44195

Cleveland Clinic Foundation, Cleveland

46015

Fisabio-Ofalmologia Medica, Valencia

46100

Oftalvist Valencia, Burjassot

47012

Hospital Universitario Rio Hortega, Valladolid

49546

Associated Retinal Consultants, Grand Rapids

Vitreo-Retinal Associates, Grand Rapids

50134

Azienda Ospedaliero-Universitaria Careggi, Florence

50200

Maharaj Nakorn ChiangMai Hospital, Chiang Mai

56124

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

60452

University Retina and Macula Associates, PC, Oak Forest

62704

Prairie Retina Center, Springfield

66424

Universitätsklinikum des Saarlandes, Homburg/Saar

72764

Northwest Arkansas Retina Associates, Springdale

75015

Centre Ophtalmologique, Paris

76092

Retina Center of Texas, Southlake

77401

Retina Consultants of Texas, Bellaire

78705

Austin Retina Associates, Austin

79106

Universitätsklinikum Freiburg, Klinik für Augenheilkunde, Freiburg im Breisgau

80045

University of Colorado, Aurora

80336

LMU Klinikum der Universität, Augenklinik, München

80909

Retina Consultants of Southern, Colorado Springs

81675

Klinikum rechts der Isar der TU München, München

85020

Associated Retina Consultants, Phoenix

85053

Retinal Research Institute, LLC, Phoenix

89144

Retina Consultants of Nevada, Las Vegas

90211

Retina-Vitreous Associates Medical Group, Beverly Hills

91436

The Retina Partners, Encino

92835

Retina Consultants of Orange County, Fullerton

93103

California Retina Consultants, Santa Barbara

93309

California Retina Consultants, Bakersfield

93454

California Retina Consultants, Santa Maria

94010

Chi De Creteil, Créteil

94040

Northern California Retina Vitreous Associates, Mountain View

94598

Bay Area Retina Associates, Walnut Creek

95825

Retinal Consultants Med Group, Sacramento

97080

Universitätsklinikum Würzburg, Augenklinik und Poliklinik, Würzburg

98383

Pacific Northwest Retina, Silverdale

100050

Beijing Friendship Hospital, Beijing

100730

Beijing Tongren Hospital, Beijing

Peking Union Medical College Hospital, Beijing

119074

National University Hospital, Singapore

130041

The Second Hospital of Jilin University, Changchun

168751

Singapore Eye Research Institute, Singapore

200072

Shanghai Tenth People's Hospital, Shanghai

200080

Shanghai First People's Hospital, Shanghai

210029

The Affiliated Eye Hospital of Nanjing Medical University, Nanjing

214000

Wuxi No.2 People's Hospital, Wuxi

300050

Tianjin Eye Hospital, Tianjin

300070

Tianjin Medical University Eye Hospital, Tianjin

308433

Tan Tock Seng Hospital, Singapore

325027

Eye Hospital, Wenzhou Medical University, Wenzhou

400014

Southwest Hospital , Third Military Medical University, Chongqing

400042

Army Medical Center of PLA(Daping Hospital), Chongqing

420066

Clinics of Eye Diseases, LLC, Kazan'

428000

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

510060

Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou

610041

West China Hospital, Sichuan University, Chengdu

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

06385

Retina Group of New England, Waterford

02111

Tufts Medical Center, Boston

07003

Envision Ocular, LLC, Bloomfield

C1015ABO

Organizacion Medica de Investigacion, Buenos Aires

C1120AAN

Oftalmos, Capital Federal

M5500GGK

Oftar, Mendoza

S2000ANJ

Centro Oftalmólogos Especialistas, Rosario

S2000DLA

Grupo Laser Vision, Rosario

74980-010

Hospital de Olhos de Aparecida - HOA, Aparecida de Goiânia

74210-010

Centro Brasileiro de Cirurgia, Goiânia

90035-003

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, São Paulo

04084-002

CEMAPE - Centro Médico, São Paulo

05403-000

Hospital das Clinicas - FMUSP, São Paulo

18031-060

Hosp de Olhos de Sorocaba, Sorocaba

T2J 0C8

Calgary Retina Consultants, Calgary

V5Z 1M9

University of British Columbia - Vancouver Coastal Health Authority, Vancouver

B3H 2Y9

QEII - HSC Department of Ophthalmology, Halifax

N6A 4V2

Ivey Eye Institute, London

K1H 8L6

University of Ottawa Eye Institute, Ottawa

M3C 0G9

Toronto Retina Institute, Toronto

M5C 2T2

Unity Health Toronto, Toronto

M5T 2S8

University Health Network Toronto Western Hospital, Toronto

J7H 1S6

Institut De L'Oeil Des Laurentides, Boisbriand

H1T 2M4

Hôpital Maisonneuve - Rosemont, Montreal

500 05

FN Hradec Králové, O?ní klinika, Hradec Králové

708 52

Faculty Hospital Ostrava, Ostrava

100 34

Faculty Hospital Kralovske Vinohrady, Prague

Unknown

AXON Clinical, Prague

The University of Hong Kong, Hong Kong

Hong Kong Eye Hospital, Mong Kok

356 01

Nemocnice Sokolov, Sokolov

01307

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

00133

Fondazione Ptv Policlinico Tor Vergata Di Roma, Rome

85-631

OFTALMIKA Sp. z o.o, Bydgoszcz

85-870

Specjalistyczny O?rodek Okulistyczny Oculomedica, Bydgoszcz

80-809

Optimum Profesorskie Centrum Okulistyki, Gdansk

44-100

Niepubliczny Zaklad Opieki Zdrowotnej PRYZMAT-OKULISTYKA, Gliwice

31-501

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

35-017

Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow, Rzeszów

42-600

Caminomed, Tarnowskie Góry

00-631

Centrum Zdrowia MDM, Warsaw

4710-243

Hospital de Braga, 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, Lisbon

02447

Kyung Hee University Hospital, Seoul

03080

Seoul National University Hospital, Seoul

06351

Samsung Medical Center, Seoul

138-736

Asan Medical Center., Seoul

08907

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat

08195

Hospital General de Catalunya, Sant Cugat del Vallès

08025

Hospital dos de maig, Barcelona

06340

Ankara University Medical Faculty; Department of Ophthalmology, Ankara

06490

Ankara Baskent University Medical Faculty; Department of Ophthalmology, Ankara

EN5 3DJ

Barnet Hospital, Barnet

BD9 6RJ

Bradford Royal Infirmary, Bradford

BS1 2LX

University Hospitals Bristol NHS Foundation Trust, Bristol Eye Hospital, Bristol

BT12 6BA

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

CT1 3NG

East Kent Hospitals University NHS Foundation Trust, Canterbury

GU16 7UJ

Frimley Park Hospital, Frimley

GL1 3NN

Gloucestershire Hospitals NHS Foundation Trust, Gloucester

NR31 6LA

James Paget University Hospitals NHS Foundation Trust, Great Yarmouth

LS9 7TF

St James University Hospital, Leeds

L7 8XP

Royal Liverpool University Hospital, Liverpool

EC1V 2PD

Moorfields Eye Hospital NHS Foundation Trust, London

NW3 2QS

Royal Free Hospital, London

SE5 9RS

Kings College Hospital, London

M13 9WL

Manchester Royal Eye Hospital, Manchester

NE1 4LP

Royal Victoria Infirmary, Newcastle upon Tyne

SO16 6YD

University Hospital Southampton NHS Foundation Trust, Southampton

SR2 9HP

Sunderland Eye Infirmary, Sunderland

UB8 3NN

Hillingdon Hospital, Uxbridge

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03622593 - A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema | Biotech Hunter | Biotech Hunter