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

PHASE3CompletedINTERVENTIONAL
Enrollment

553

Participants

Timeline

Start Date

March 2, 2021

Primary Completion Date

July 6, 2022

Study Completion Date

June 12, 2023

Conditions
Macular EdemaBranch Retinal 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 intravitreal (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 (150)

333

Chang Gung Medical Foundation - Linkou; Ophthalmology, Taoyuan District

500

Changhua Christian Hospital; Department of Ophthalmology, Changhua

1133

Budapest Retina Associates Kft., Budapest

2000

Save Sight Institute, Sydney

Sydney Retina Clinic and Day Surgery, Sydney

2135

Strathfield Retina Clinic, Strathfield

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

7621

Ganglion Medial Center, Pécs

8036

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

10002

National Taiwan University Hospital; Ophthalmology, Zhongzheng Dist.

11217

Taipei Veterans General Hospital; Ophthalmology, Taipei

11788

Long Is. Vitreoretinal Consult, Hauppauge

13088

Retina Vit Surgeons/Central NY, Liverpool

20100

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

21740

Cumberland Valley Retina PC, Hagerstown

28046

Clinica Baviera; Servicio Oftalmologia, Madrid

28602

Graystone Eye, Hickory

30909

Southeast Retina Center, Augusta

31008

Clinica Universitaria de Navarra; Servicio de Oftalmologia, Pamplona

32308

Southern Vitreoretinal Assoc, Tallahassee

32901

Florida Eye Associates, Melbourne

33324

Fort Lauderdale Eye Institute, Plantation

33609

Retina Associates of Florida, LLC, Tampa

33711

Retina Vitreous Assoc of FL, St. Petersburg

37075

Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde, Göttingen

37203

Tennessee Retina PC, Nashville

38138

Charles Retina Institute, Germantown

42415

Yeungnam University Medical Center, Daegu

45242

Cincinnati Eye Institute, Cincinnati

46100

Oftalvist Valencia, Burjassot

47012

Hospital Universitario Rio Hortega; Servicio de Oftalmologia, Valladolid

48073

Assoc Retinal Consultants PC, Royal Oak

50134

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

55435

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

57701

Black Hills Eye Institute, Rapid City

60452

University Retina and Macula Associates, PC, Oak Forest

62704

Prairie Retina Center, Springfield

63017

Midwest Vision Research Foundation, Chesterfield

67063

Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik, Ludwigshafen

75010

Hopital Lariboisiere; Ophtalmologie, Paris

75231

Texas Retina Associates, Dallas

76087

Strategic Clinical Research Group, LLC, Willow Park

79106

Universitätsklinikum Freiburg, Klinik für Augenheilkunde, Freiburg im Breisgau

79606

Retina Res Institute of Texas, Abilene

80909

Retina Consultants of Southern Colorado PC, Colorado Springs

84107

Retina Associates of Utah, PLLC, Salt Lake City

85014

Retinal Research Institute, LLC, Phoenix

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

95008

Retinal Diagnostic Center, Campbell

96701

Retina Consultants of Hawaii, ‘Aiea

100730

Beijing Hospital of Ministry of Health, Beijing

110034

He Eye Specialist Shenyang Hospital, Shenyang

130041

The Second Hospital of Jilin University, Changchun

150001

The 2nd Affiliated Hospital of Harbin Medical University, Harbin

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

300050

Tianjin Eye Hospital, Tianjin

300070

Tianjin Medical University Eye Hospital, Tianjin

308433

Tan Tock Seng Hospital; Ophthalmology Department, Singapore

325027

Eye Hospital, Wenzhou Medical University, Wenzhou

420066

Clinics of Eye Diseases, LLC, Kazan'

430060

Renmin Hospital of Wuhan University, Wuhan

450059

Clinic Optimed, Ufa

510060

Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou

610041

West China Hospital, Sichuan University, Chengdu

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

06385

Retina Group of New England, Waterford

30060-1137

Georgia Retina PC, Marietta

02111

Tufts Medical Center; Ophthalmology, Boston

07666

Retina Associates of NJ, Teaneck

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

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

708 52

Faculty Hospital Ostrava; Ophthalmology clinic, Ostrava

100 34

Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic, Prague

356 01

Nemocnice Sokolov, Sokolov

00133

Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche, 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

963-8052

Southern TOHOKU Eye Clinic, Fukushima

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

606-8507

Kyoto University Hospital, Kyoto

770-8503

Tokushima University Hospital, Tokushima

101-8309

Nihon University Hospital, Tokyo

193-0998

Tokyo Medical University Hachioji Medical Center, Tokyo

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

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

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

3000-075

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

3030-163

Espaco Medico Coimbra, Coimbra

4099-001

Centro Hospitalar Universitário do Porto ? Hospital de Santo António; Servico de Oftalmologia, Porto

602-739

Pusan National University Hospital, Busan

463-707

Seoul National University Bundang Hospital, Seongnam-si

02447

Kyung Hee University Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08025

Hospital dos de maig; servicio de oftalmologia, Barcelona

BT12 6BA

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

BS1 2LX

Bristol Eye Hospital;Retinal Treatment and Research Unit, Bristol

CF14 4XW

University Hospital of Wales, Cardiff

GL1 3NN

Gloucestershire Hospitals NHS Foundation Trust, Gloucestershire

LS9 7TF

St James University Hospital, Leeds

NW10 7NS

Central Middlesex Hospital, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Chugai Pharmaceutical

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY