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

PHASE3CompletedINTERVENTIONAL
Enrollment

658

Participants

Timeline

Start Date

March 11, 2019

Primary Completion Date

October 5, 2020

Study Completion Date

January 7, 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 treatment arms at applicable visits to maintain masking.

Trial Locations (137)

333

Chang Gung Medical Foundation - Linkou, Taoyuan District

500

Changhua Christian Hospital, Changhua

1023

Fundacion Zambrano, CABA

1090

Medizinische Universität Wien, Vienna

1106

Bajcsy-Zsilinszky Hospital, Budapest

1134

Magyar Honvedseg Egeszsegugyi Kozpont, Budapest

1233

Specialized Hospital for Active Treatment of Eye Diseases Zora, Sofia

1309

"Pentagram Eye Hospital (Medical Center Pentagram)", Sofia

2000

Sydney Eye Hospital, Sydney

Sydney Retina Clinic and Day Surgery, Sydney

2135

Strathfield Retina Clinic, Strathfield

2145

Sydney West Retina, Westmead

2150

Marsden Eye Research Centre, Parramatta

2600

Rigshospitalet Glostrup, Glostrup Municipality

2640

Eyeclinic Albury Wodonga, Albury

3002

Centre For Eye Research Australia, East Melbourne

3178

Retina Specialists Victoria, Rowville

4000

Sjællands Universitetshospital, Roskilde, Roskilde

6009

The Lions Eye Institute, Nedlands

6351

Samsung Medical Center, Seoul

6720

Szegedi Tudományegyetem ÁOK, Szeged

8036

LKH-Univ.Klinikum Graz, Graz

11217

Taipei Veterans General Hospital, Taipei

11967

Island Retina, Shirley

13008

Centre Paradis Monticelli, Marseille

13620

Seoul National University Bundang Hospital, Gyeonggi-do

16132

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

20157

Asst Fatebenefratelli Sacco, Milan

21204

Retina Specialists, Towson

21209

The Retina Care Center, Baltimore

21740

Cumberland Valley Retina PC, Hagerstown

23502

Wagner Kapoor Institute, Norfolk

24502

Piedmont Eye Center, Lynchburg

29169

Palmetto Retina Center, West Columbia

30060

Georgia Retina PC, Marietta

30909

Southeast Retina Center, Augusta

32308

Southern Vitreoretinal Assoc, Tallahassee

33012

Instituto Oftalmologico Fernandez Vega, Oviedo

33100

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

33308

Retina Group of Florida, Fort Lauderdale

33410

Retina Care Specialists, Palm Beach Gardens

33609

Retina Associates of Florida, LLC, Tampa

35100

Ege University Medical Faculty, Izmir

37421

Southeastern Retina Associates Chattanooga, Chattanooga

37540

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

40225

Universitätkslinikum Düsseldorf, Augenklinik, Düsseldorf

42415

Yeungnam University Medical Center, Daegu

43016

Midwest Retina, Dublin

43212

The Ohio State University Havener Eye Institute, Columbus

44093

CHU Nantes - Hôtel Dieu, Nantes

44122

Retina Assoc of Cleveland Inc, Cleveland

46290

Raj K. Maturi, MD PC, Indianapolis

47012

Hospital Universitario Rio Hortega, Valladolid

48145

Augenabteilung am St. Franziskus-Hospital, Münster

48149

Universitätsklinikum Münster, Münster

49241

Pusan National University Hospital, Busan

50009

Hospital Universitario Miguel Servet, Zaragoza

50134

Azienda Ospedaliero-Universitaria Careggi, Florence

50266

Wolfe Eye Clinic, West Des Moines

50937

Universitätsklinikum Köln, Cologne

55435

VitreoRetinal Surgery, PLLC., Minneapolis

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

69130

Pole Vision Val d'Ouest, Écully

69317

Hopital de la croix rousse, Lyon

75006

Centre Odeon, Paris

75010

Hopital Lariboisiere, Paris

75015

Centre Ophtalmologique, Paris

76051

Retina Center of Texas, Grapevine

76087

Strategic Clinical Research Group, LLC, Willow Park

77384

Retina Consultants of Houston, The Woodlands

78705

Austin Retina Associates, Austin

78750

Austin Clinical Research LLC, Austin

79606

Retina Res Institute of Texas, Abilene

80401

Colorado Retina Associates, PC, Golden

84107

Retina Associates of Utah, PLLC, Murray

85020

Associated Retina Consultants, Phoenix

85021

Arizona Retina and Vitreous Consultants, Phoenix

92705

Orange County Retina Med Group, Santa Ana

93103

California Retina Consultants, Santa Barbara

94010

Chi De Creteil, Créteil

94040

Northern California Retina Vitreous Associates, Mountain View

95825

Retinal Consultants Med Group, Sacramento

96701

Retina Consultants of Hawaii, ‘Aiea

98383

Pacific Northwest Retina, Silverdale

100050

Beijing Friendship Hospital, Beijing

100730

Beijing Tongren Hospital, Beijing

Peking Union Medical College Hospital, Beijing

110034

He Eye Specialist Shenyang Hospital, Shenyang

119074

National University Hospital, Singapore

130041

The Second Hospital of Jilin University, Changchun

150081

The Second 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, Saint Petersburg

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

325027

Eye Hospital, Wenzhou Medical University, Wenzhou

400014

Southwest Hospital , Third Military Medical University, Chongqing

400042

Army Medical Center of PLA(Daping Hospital), Chongqing

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

04101

Maine Eye Center, Portland

02114

Ophthalmic Consultants of Boston, Boston

08034

Mid Atlantic Retina - Wills Eye Hospital, Cherry Hill

C1015ABO

Organizacion Medica de Investigacion, Buenos Aires

C1116

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

C1120AAN

Oftalmos, Capital Federal

C1061AAE

Buenos Aires Mácula, Ciudad Autonoma Buenos Aires

M5500GGK

Oftar, Mendoza

S2000DLA

Grupo Laser Vision, Rosario

74980-010

Hospital de Olhos de Aparecida - HOA, Aparecida de Goiânia

04023-062

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

Unknown

The University of Hong Kong, Hong Kong

Hong Kong Eye Hospital, Mong Kok

00133

Fondazione Ptv Policlinico Tor Vergata Di Roma, Rome

85-631

OFTALMIKA Sp. z o.o, Bydgoszcz

80-809

Optimum Profesorskie Centrum Okulistyki, Gdansk

31-501

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

42-600

Caminomed, Tarnowskie Góry

3000-075

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

4200-319

Hospital de Sao Joao, Porto

02447

Kyung Hee University Hospital, Seoul

03080

Seoul National University Hospital, Seoul

06192

Nune Eye Hospital, Seoul

138-736

Asan Medical Center., Seoul

08907

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat

08022

Institut de la Macula i la retina, Barcelona

08028

Hospital Clinic de Barcelona, Barcelona

06100

Hacettepe University Medical Faculty, Ankara

06340

Ankara University Medical Faculty, Ankara

06560

Gazi University Faculty of Medicine, Ankara

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03823300 - A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE) | Biotech Hunter | Biotech Hunter