A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion

PHASE3CompletedINTERVENTIONAL
Enrollment

729

Participants

Timeline

Start Date

March 2, 2021

Primary Completion Date

August 9, 2022

Study Completion Date

July 12, 2023

Conditions
Macular EdemaCentral Retinal Vein OcclusionHemiretinal Vein Occlusion
Interventions
DRUG

Faricimab

Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.

DRUG

Aflibercept

Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).

PROCEDURE

Sham Procedure

The sham is a procedure that mimics an IVT injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.

Trial Locations (194)

333

Chang Gung Medical Foundation - Linkou; Ophthalmology, Taoyuan District

500

Changhua Christian Hospital; Department of Ophthalmology, Changhua

1090

Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie, Vienna

1106

Bajcsy-Zsilinszky Hospital, Budapest

1133

Budapest Retina Associates Kft., Budapest

2000

Save Sight Institute, Sydney

Sydney Retina Clinic and Day Surgery, Sydney

2135

Strathfield Retina Clinic, Strathfield

2640

Eyeclinic Albury Wodonga, Albury

3002

Centre For Eye Research Australia, East Melbourne

3178

Retina Specialists Victoria, Rowville

4032

Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika, Debrecen

6009

The Lions Eye Institute, Nedlands

6720

Szegedi Tudományegyetem ÁOK; Department of Ophtalmology, Szeged

8036

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

8900

Zala Megyei Kórház; SZEMESZET, Zalaegerszeg

11217

Taipei Veterans General Hospital; Ophthalmology, Taipei

11788

Long Is. Vitreoretinal Consult, Hauppauge

13088

Retina Vit Surgeons/Central NY, Liverpool

14620

Retina Assoc of Western NY, Rochester

19107

Mid Atlantic Retina - Wills Eye Hospital, Philadelphia

20132

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

20815

Retina Group of Washington, Chevy Chase

21287

Johns Hopkins Med; Wilmer Eye Inst, Baltimore

21740

Cumberland Valley Retina PC, Hagerstown

24502

Piedmont Eye Center, Lynchburg

26506

West Virginia University Eye Institute, Morgantown

28222

Hospital Universitario Puerta de Hierro, Majadahonda

29169

Palmetto Retina Center, West Columbia

29456

Charleston Neuroscience Institute, Ladson

30909

Southeast Retina Center, Augusta

31008

Complejo Hospitalario de Navarra; Servicio de oftalmologia, Pamplona

32901

Florida Eye Associates, Melbourne

33064

Advanced Research, Deerfield Beach

Rand Eye, Deerfield Beach

33324

Fort Lauderdale Eye Institute, Plantation

33609

Retina Associates of Florida, LLC, Tampa

33711

Retina Vitreous Assoc of FL, St. Petersburg

37203

Tennessee Retina PC, Nashville

37540

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

38138

Charles Retina Institute, Germantown

40549

Internationale Innovative Ophthalmochirurgie GbR; c/o Makula-Netzhaut-Zentrum Breyer Kaymak Klabe, Düsseldorf-Oberkassel

42415

Yeungnam University Medical Center, Daegu

45242

Cincinnati Eye Institute, Cincinnati

47012

Hospital Universitario Rio Hortega; Servicio de Oftalmologia, Valladolid

48073

Assoc Retinal Consultants PC, Royal Oak

55435

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

57701

Black Hills Eye Institute, Rapid City

60126

Retina Associated Ltd, Elmhurst

60452

University Retina and Macula Associates, PC, Oak Forest

60611

Northwestern Medical Group/Northwestern University, Chicago

62704

Prairie Retina Center, Springfield

63017

Midwest Vision Research Foundation, Chesterfield

66215

Retina Associates, Lenexa

67063

Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik, Ludwigshafen

75010

Hopital Lariboisiere; Ophtalmologie, Paris

75015

Centre Ophtalmologique; Imagerie et laser, Paris

75231

Texas Retina Associates, Dallas

76087

Strategic Clinical Research Group, LLC, Willow Park

78750

Austin Clinical Research LLC, Austin

79106

Universitätsklinikum Freiburg, Klinik für Augenheilkunde, Freiburg im Breisgau

79606

Retina Res Institute of Texas, Abilene

80228

Colorado Retina Associates, PC, Lakewood

80909

Retina Consultants of Southern Colorado PC, Colorado Springs

84107

Retina Associates of Utah, PLLC, Salt Lake City

85014

Retinal Research Institute, LLC, Phoenix

85206

Barnet Dulaney Perkins Eye Center, Mesa

85704

Retina Associates Southwest PC, Tucson

89502

Sierra Eye Associates, Reno

91107

California Eye Specialists Medical group Inc., Pasadena

91436

The Retina Partners, Encino

92064

Retina Consultants, San Diego, Poway

94010

Chi De Creteil; Ophtalmologie, Créteil

94040

Northern California Retina Vitreous Associates, Mountain View

94109

West Coast Retina Medical Group, San Francisco

94609

East Bay Retina Consultants, Oakland

95008

Retinal Diagnostic Center, Campbell

96701

Retina Consultants of Hawaii, ‘Aiea

97221

Retina Northwest, Portland

97477

Cascade Medical Research Institute LLC, Springfield

100730

Beijing Hospital of Ministry of Health, Beijing

110034

He Eye Specialist Shenyang Hospital, Shenyang

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

130041

The Second Hospital of Jilin University, Changchun

150001

The 2nd Affiliated Hospital of Harbin Medical University, Harbin

168751

Singapore Eye Research Institute, Singapore

197022

1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology, Saint Petersburg

200072

Shanghai Tenth People's Hospital, Shanghai

200080

Shanghai First People's Hospital, Shanghai

300050

Tianjin Eye Hospital, Tianjin

300070

Tianjin Medical University Eye Hospital, Tianjin

308433

Tan Tock Seng Hospital; Ophthalmology Department, Singapore

310009

The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

325027

Eye Hospital, Wenzhou Medical University, Wenzhou

428000

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

430060

Renmin Hospital of Wuhan University, Wuhan

450059

Clinic Optimed, Ufa

510060

Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou

518053

The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee, Shenzhen

610041

West China Hospital, Sichuan University, Chengdu

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

78705-1169

Austin Retina Associates, Austin

77401-3510

Retina & Vitreous of Texas, Bellaire

77384-4167

Retina Consultants of Texas, The Woodlands

C1017AAO

Fundacion Zambrano, CABA

C1015ABO

Centro Oftalmológico Dr. Charles S.A., Capital Federal

Organizacion Medica de Investigacion, San Nicolás

C1120AAN

Oftalmos, Capital Federal

C1199ABC

Hospital Italiano; Ophtalmology, Capital Federal

C1061AAE

Buenos Aires Mácula, Ciudad Autonoma Buenos Aires

M5500GGK

Oftar, Mendoza

S2000ANJ

Centro Oftalmólogos Especialistas, Rosario

S2000DLA

Grupo Laser Vision, Rosario

74980-010

Hospital de Olhos de Aparecida - HOA, Aparecida de Goiânia

90035-903

Hospital das Clinicas - UFRGS, Porto Alegre

89052-504

Botelho Hospital da Visao, Blumenau

04023-062

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

18031-060

Hosp de Olhos de Sorocaba, Sorocaba

Unknown

Henan Provincial Eye Hosptial, Zhengzhou

AXON Clinical, Prague

Queen Mary Hospital; Department of Ophthalmology, Hong Kong

Hong Kong Eye Hospital; CUHK Eye Centre, Mong Kok

128 08

General Teaching Hospital Prague; Ophthalmology clinic, Prague

00198

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

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

078-8510

Asahikawa Medical University Hospital, Hokkaido

660-8550

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

663-8501

Hyogo Medical University Hospital, Hyōgo

310-0845

Kozawa eye hospital and diabetes center, Ibaraki

761-0793

Kagawa University Hospital, Kagawa

890-8520

Kagoshima University Hospital, Kagoshima

514-8507

Mie University Hospital, Mie

960-1295

Fukushima Medical University Hospital, Miyagi

390-8621

Shinshu University Hospital, Nagano

545-8586

Osaka Metropolitan University Hospital, Osaka

570-8507

Kansai Medical University Medical Center, Osaka

162-8666

Tokyo Women's Medical University Hospital, Tokyo

193-0998

Tokyo Medical University Hachioji Medical Center, Tokyo

43-309

Szpital sw. Lukasza, Bielsko-Biala

85-631

OFTALMIKA Sp. z o.o, Bydgoszcz

85-870

Specjalistyczny O?rodek Okulistyczny Oculomedica, 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 Dietla 19 Sp. Z O.O., Krakow

31-501

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

38-400

MT Medic Krosno, Krosno

24-140

O?rodek Chirurgii Oka Prof. Zagórskiego Na??czów, Na??czów

05-500

Centrum Medyczne Pulawska SP. z o.o., Piaseczno

44-203

Lens Clinic, Rybnik

42-600

Caminomed, Tarnowskie Góry

00-189

Centrum Zdrowia MDM, Warsaw

53-334

SPEKTRUM Osrodek Okulistyki Klinicznej, Wroclaw

3000-075

Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia, Coimbra

3030-163

Espaco Medico Coimbra, Coimbra

1649-035

Hospital de Santa Maria; Servico de Oftalmologia, Lisbon

602-739

Pusan National University Hospital, Busan

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

07301

Kim's Eye Hospital, Seoul

08907

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat

08195

Hospital General de Catalunya, San Cugat Del Valles

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

BT12 6BA

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

B18 7QH

Birmingham Midland Eye Centre, Birmingham

BD9 6RJ

Opthalmology Research Office, Bradford

BS1 2LX

Bristol Eye Hospital;Retinal Treatment and Research Unit, Bristol

CF14 4XW

University Hospital of Wales, Cardiff

LS9 7TF

St James University Hospital, Leeds

L7 8YE

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

NW10 7NS

Central Middlesex Hospital, London

ME16 9QQ

Maidstone and Tunbridge Wells NHS Trust, Maidstone

NE1 4LP

Royal Victoria Infirmary, Newcastle upon Tyne

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Chugai Pharmaceutical

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY