A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)

PHASE3CompletedINTERVENTIONAL
Enrollment

671

Participants

Timeline

Start Date

February 19, 2019

Primary Completion Date

October 26, 2020

Study Completion Date

January 18, 2022

Conditions
Wet Macular Degeneration
Interventions
DRUG

Faricimab

Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.

DRUG

Aflibercept

Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).

PROCEDURE

Sham Procedure

The sham is a procedure that mimics an intravitreal 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 (161)

1133

Budapest Retina Associates Kft., Budapest

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

4102

Vista Klinik Ophthalmologische Klinik, Binningen

7621

Ganglion Medial Center, Pécs

8063

Stadtspital Triemli Ophthalmologische Klinik, Zurich

8900

Zala Megyei Kórház, Zalaegerszeg

11021

Long Is. Vitreoretinal Consult, Great Neck

11572

Ophthalmic Cons of Long Island, Oceanside

12159

The Retina Consultants, Slingerlands

13224

Retina Vit Surgeons/Central NY, Syracuse

14620

Retina Assoc of Western NY, Rochester

15706

Instituto Oftalmologico Gomez Ulla, Santiago de Compostela

19107

Mid Atlantic Retina - Wills Eye Hospital, Philadelphia

20100

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena, Milan

20815

Retina Group of Washington, Chevy Chase

21287

Johns Hopkins Med, Baltimore

28027

Clinica Universitaria de Navarra, Madrid

28046

Clinica Baviera, 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

29456

Charleston Neuroscience Inst, Ladson

31008

Clinica Universitaria de Navarra, Pamplona

32503

Retina Specialty Institute, Pensacola

32901

Florida Eye Associates, Melbourne

33064

Rand Eye, Deerfield Beach

33324

Fort Lauderdale Eye Institute, Plantation

33711

Retina Vitreous Assoc of FL, St. Petersburg

37203

Tennessee Retina PC., Nashville

38138

Charles Retina Institute, Germantown

41380

Kocaeli Üniversitesi Tıp Fakültesi; Department of Ophthalmology, Kocaeli

42130

Selcuk University Faculty of Medicine; Department Of Ophthalmology, Konya

45242

Cincinnati Eye Institute, Cincinnati

46100

Oftalvist Valencia, Burjassot

49546

Associated Retinal Consultants, Grand Rapids

57701

Black Hills Eye Institute, Rapid City

60611

Northwestern Medical Group/Northwestern University, Chicago

63017

Midwest Vision Research Foundation, Chesterfield

63031

Retina Associates of St. Louis, Florissant

64060

Montemayor & Asociados (Oftalmologos), Monterrey

66100

Ospedale Clinicizzato SS Annunziata, Chieti

66215

Retina Associates, Lenexa

69120

Universitätsklinik Heidelberg, Heidelberg

72076

Universitätsklinikum Tübingen, Tübingen

75231

Texas Retina Associates, Dallas

77025

Retina & Vitreous of Texas, Houston

77030

Retina Consultants of Texas, Houston

78503

Valley Retina Institute P.A., McAllen

79106

Universitätsklinikum Freiburg, Klinik für Augenheilkunde, Freiburg im Breisgau

80909

Retina Consultants of Southern, Colorado Springs

84107

Rocky Mountain Retina, Salt Lake City

85014

Retinal Research Institute, LLC, Phoenix

85016

Barnet Dulaney Perkins Eye Center, Phoenix

85704

Retina Associates Southwest PC, Tucson

89502

Sierra Eye Associates, Reno

90807

South Coast Retina Center, Long Beach

91107

California Eye Specialists Medical group Inc., Pasadena

91120

Hadassah MC, Jerusalem

91436

The Retina Partners, Encino

92064

Retina Consultants, San Diego, Poway

92093

Jacobs Retina center at the Shiley eye Institute UCSD, La Jolla

92211

Southern CA Desert Retina Cons, Palm Desert

92373

Retina Consultants of Southern California, Redlands

95008

Retinal Diagnostic Center, Campbell

95817

University of California, Davis, Eye Center, Sacramento

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

124044

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

420066

Clinics of Eye Diseases, LLC, Kazan'

3109601

Rambam Medical Center, Haifa

4941492

Rabin MC, Petah Tikva

6423906

Tel Aviv Sourasky MC, Tel Aviv

7660101

Kaplan Medical Center, Rehovot

06320

Retina Group of New England, New London

02111

Tufts Medical Center, Boston

08820

NJ Retina, Edison

07666

Retina Associates of NJ, Teaneck

T2J 0C8

Calgary Retina Consultants, Calgary

V5Z 1M9

University of British Columbia - Vancouver Coastal Health Authority, Vancouver

N6A 4V2

Ivey Eye Institute, London

K1H 8L5

University of Ottawa Eye Institute, Ottawa

K2B 7E9

Retina Institute of Ottawa, Ottawa

M3C 0G9

Toronto Retina Institute, Toronto

M5C 2T2

Unity Health Toronto, Toronto

J7H 1S6

Institut De L'Oeil Des Laurentides, Boisbriand

J1G 2V4

Michel Giunta Clinique Medical, Sherbrooke

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, Perugia

457-8510

Chukyo Hospital, Aichi

466-8560

Nagoya University Hospital, Aichi

467-8602

Nagoya City University Hospital, Aichi

480-1195

Aichi Medical University Hospital, Aichi

491-8551

Daiyukai Daiichi Hospital, Aichi

260-8677

Chiba University Hospital, Chiba

285-8741

Toho University Sakura Medical Center, Chiba

812-0011

Hayashi Eye Hospital, Fukuoka

830-0011

Kurume University Hospital, Fukuoka

963-8052

Southern TOHOKU Eye Clinic, Fukushima

060-8604

Sapporo City General Hospital, Hokkaido

060-8648

Hokkaido University Hospital, Hokkaido

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

860-0027

Ideta Eye Hospital, Kumamoto

606-8507

Kyoto University Hospital, Kyoto

514-8507

Mie University Hospital, Mie

960-1295

Fukushima Medical University Hospital, Miyagi

889-1692

University of Miyazaki Hospital, Miyazaki

390-8621

Shinshu University Hospital, Nagano

395-8502

Iida Municipal Hospital, Nagano

852-8511

Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki

634-8522

Nara Medical University Hospital, Nara

903-0125

University of the Ryukyus Hospital, Okinawa

530-8480

Kitano Hospital, Osaka

545-8586

Osaka Metropolitan University Hospital, Osaka

570-8507

Kansai Medical University Medical Center, Osaka

573-1191

Kansai Medical University Hospital, Osaka

359-8513

National Defense Medical College Hospital, Saitama

520-2192

Shiga University Of Medical Science Hospital, Shiga

770-8503

Tokushima University Hospital, Tokushima

101-8309

Nihon University Hospital, Tokyo

111-0051

Takeuchi eye clinic, Tokyo

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

3011 BH

Het Oogziekenhuis Rotterdam, Rotterdam

5022 GC

ETZ Elisabeth, Tilburg

43-309

Szpital sw. Lukasza, Bielsko-Biala

85-870

Specjalistyczny O?rodek Okulistyczny Oculomedica, Bydgoszcz

41-902

Szpital Specjalistyczny nr 1, Bytom

80-822

Dobry Wzrok Sp Z O O, Gdansk

40-594

Gabinet Okulistyczny Prof Edward Wylegala, Katowice

31-070

Centrum Medyczne Dietla 19 Sp. Z O.O., Krakow

53-334

SPEKTRUM Osrodek Okulistyki Klinicznej, Wroclaw

08195

Hospital General de Catalunya, Sant Cugat del Vallès

08025

Hospital dos de maig, Barcelona

06490

Ankara Baskent University Medical Faculty; Department of Ophthalmology, Ankara

BD9 6RJ

Bradford Royal Infirmary, Bradford

BS1 2LX

Bristol Eye Hospital, Bristol

CF14 4XW

University Hospital of Wales, Cardiff

GU16 7UJ

Frimley Park Hospital, Frimley

GL1 3NN

Gloucestershire Royal Hospital, Gloucester

HU3 2JZ

Hull Royal Infirmary, Hull

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

M13 9WL

Manchester Royal Infirmary, Manchester

NE1 4LP

Royal Victoria Infirmary, Newcastle upon Tyne

SO16 6YD

Southampton General Hospital, Southampton

WV10 0QP

New Cross Hospital, Wolverhampton

YO31 8HE

The York Hospital, York

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03823287 - A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA) | Biotech Hunter | Biotech Hunter