A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)
NCT ID: NCT03823300
Last Updated: 2025-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
658 participants
INTERVENTIONAL
2019-03-11
2022-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A: Faricimab
Faricimab
Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
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.
Arm B: Aflibercept
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).
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.
Interventions
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Faricimab
Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
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).
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to comply with the study protocol, in the investigator's judgment
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment
Exclusion Criteria
* Pregnancy or breastfeeding, or intention to become pregnant during the study
* CNV due to causes other than AMD in the study eye
* Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
* Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
* Uncontrolled glaucoma in the study eye
* Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
* Prior IVT administration of faricimab in either eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Active ocular inflammation or suspected or active ocular or periocular infection in either eye
50 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Associated Retina Consultants
Phoenix, Arizona, United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, United States
Northern California Retina Vitreous Associates
Mountain View, California, United States
Retinal Consultants Med Group
Sacramento, California, United States
Orange County Retina Med Group
Santa Ana, California, United States
California Retina Consultants
Santa Barbara, California, United States
Colorado Retina Associates, PC
Golden, Colorado, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
Retina Care Specialists
Palm Beach Gardens, Florida, United States
Southern Vitreoretinal Assoc
Tallahassee, Florida, United States
Retina Associates of Florida, LLC
Tampa, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Georgia Retina PC
Marietta, Georgia, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States
Prairie Retina Center
Springfield, Illinois, United States
Raj K. Maturi, MD PC
Indianapolis, Indiana, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
Maine Eye Center
Portland, Maine, United States
The Retina Care Center
Baltimore, Maryland, United States
Cumberland Valley Retina PC
Hagerstown, Maryland, United States
Retina Specialists
Towson, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
VitreoRetinal Surgery, PLLC.
Minneapolis, Minnesota, United States
Mid Atlantic Retina - Wills Eye Hospital
Cherry Hill, New Jersey, United States
Island Retina
Shirley, New York, United States
Retina Assoc of Cleveland Inc
Cleveland, Ohio, United States
The Ohio State University Havener Eye Institute
Columbus, Ohio, United States
Midwest Retina
Dublin, Ohio, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Southeastern Retina Associates Chattanooga
Chattanooga, Tennessee, United States
Retina Res Institute of Texas
Abilene, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Austin Clinical Research LLC
Austin, Texas, United States
Retina Center of Texas
Grapevine, Texas, United States
Retina Consultants of Houston
The Woodlands, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
Retina Associates of Utah, PLLC
Murray, Utah, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Wagner Kapoor Institute
Norfolk, Virginia, United States
Pacific Northwest Retina
Silverdale, Washington, United States
Organizacion Medica de Investigacion
Buenos Aires, , Argentina
Fundacion Zambrano
CABA, , Argentina
Centro Oftalmológico Dr. Charles S.A.
Capital Federal, , Argentina
Oftalmos
Capital Federal, , Argentina
Buenos Aires Mácula
Ciudad Autonoma Buenos Aires, , Argentina
Oftar
Mendoza, , Argentina
Grupo Laser Vision
Rosario, , Argentina
Eyeclinic Albury Wodonga
Albury, New South Wales, Australia
Marsden Eye Research Centre
Parramatta, New South Wales, Australia
Strathfield Retina Clinic
Strathfield, New South Wales, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, Australia
Sydney West Retina
Westmead, New South Wales, Australia
Centre For Eye Research Australia
East Melbourne, Victoria, Australia
Retina Specialists Victoria
Rowville, Victoria, Australia
The Lions Eye Institute
Nedlands, Western Australia, Australia
LKH-Univ.Klinikum Graz
Graz, , Austria
Medizinische Universität Wien
Vienna, , Austria
Hospital de Olhos de Aparecida - HOA
Aparecida de Goiânia, Goiás, Brazil
Universidade Federal de Sao Paulo - UNIFESP*X
São Paulo, São Paulo, Brazil
Specialized Hospital for Active Treatment of Eye Diseases Zora
Sofia, , Bulgaria
Pentagram Eye Hospital (Medical Center "Pentagram")
Sofia, , Bulgaria
Beijing Friendship Hospital
Beijing, , China
Beijing Tongren Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
The Second Hospital of Jilin University
Changchun, , China
West China Hospital, Sichuan University
Chengdu, , China
Southwest Hospital , Third Military Medical University
Chongqing, , China
Army Medical Center of PLA(Daping Hospital)
Chongqing, , China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, , China
The Second Affiliated Hospital of Harbin Medical University
Harbin, , China
The Affiliated Eye Hospital of Nanjing Medical University
Nanjing, , China
Shanghai First People's Hospital
Shanghai, , China
He Eye Specialist Shenyang Hospital
Shenyang, , China
Tianjin Eye Hospital
Tianjin, , China
Eye Hospital, Wenzhou Medical University
Wenzhou, , China
Wuxi No.2 People's Hospital
Wuxi, , China
Rigshospitalet Glostrup
Glostrup Municipality, , Denmark
Sjællands Universitetshospital, Roskilde
Roskilde, , Denmark
Chi De Creteil
Créteil, , France
Pole Vision Val d'Ouest
Écully, , France
Hopital de la croix rousse
Lyon, , France
Centre Paradis Monticelli
Marseille, , France
CHU Nantes - Hôtel Dieu
Nantes, , France
Centre Odeon
Paris, , France
Hopital Lariboisiere
Paris, , France
Centre Ophtalmologique
Paris, , France
Centres Ophtalmologique St Exupéry
Saint-Cyr-sur-Loire, , France
Universitätsklinikum Köln
Cologne, , Germany
Universitätkslinikum Düsseldorf, Augenklinik
Düsseldorf, , Germany
Augenabteilung am St. Franziskus-Hospital
Münster, , Germany
Universitätsklinikum Münster
Münster, , Germany
The University of Hong Kong
Hong Kong, , Hong Kong
Hong Kong Eye Hospital
Mong Kok, , Hong Kong
Bajcsy-Zsilinszky Hospital
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Szegedi Tudományegyetem ÁOK
Szeged, , Hungary
Fondazione Ptv Policlinico Tor Vergata Di Roma
Rome, Lazio, Italy
UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.
Genoa, Liguria, Italy
Asst Fatebenefratelli Sacco
Milan, Lombardy, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany, Italy
Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello
Pisa, Tuscany, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine
Udine, Veneto, Italy
OFTALMIKA Sp. z o.o
Bydgoszcz, , Poland
Optimum Profesorskie Centrum Okulistyki
Gdansk, , Poland
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
Krakow, , Poland
Caminomed
Tarnowskie Góry, , Poland
Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia
Coimbra, , Portugal
Hospital de Sao Joao
Porto, , Portugal
Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov
Cheboksary, Mariy-El Republic, Russia
1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov
Saint Petersburg, Sankt-Peterburg, Russia
?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch
Irkutsk, , Russia
?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch
Novosibirsk, , Russia
National University Hospital
Singapore, , Singapore
Singapore Eye Research Institute
Singapore, , Singapore
Pusan National University Hospital
Busan, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Nune Eye Hospital
Seoul, , South Korea
Asan Medical Center.
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Instituto Oftalmologico Fernandez Vega
Oviedo, Principality of Asturias, Spain
Institut de la Macula i la retina
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Rio Hortega
Valladolid, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Changhua Christian Hospital
Changhua, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, , Taiwan
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Gazi University Faculty of Medicine
Ankara, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Countries
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References
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Khanani AM, Kotecha A, Chang A, Chen SJ, Chen Y, Guymer R, Heier JS, Holz FG, Iida T, Ives JA, Lim JI, Lin H, Michels S, Quezada Ruiz C, Schmidt-Erfurth U, Silverman D, Singh R, Swaminathan B, Willis JR, Tadayoni R; TENAYA and LUCERNE Investigators. TENAYA and LUCERNE: Two-Year Results from the Phase 3 Neovascular Age-Related Macular Degeneration Trials of Faricimab with Treat-and-Extend Dosing in Year 2. Ophthalmology. 2024 Aug;131(8):914-926. doi: 10.1016/j.ophtha.2024.02.014. Epub 2024 Feb 19.
Takahashi K, Cheung CMG, Iida T, Lai TYY, Ohji M, Yanagi Y, Kawano M, Ohsawa S, Suzuki T, Kotecha A, Lin H, Patel V, Swaminathan B, Lee WK; TENAYA, LUCERNE Investigators. Efficacy, durability, and safety of faricimab in patients from Asian countries with neovascular age-related macular degeneration: 1-Year subgroup analysis of the TENAYA and LUCERNE trials. Graefes Arch Clin Exp Ophthalmol. 2023 Nov;261(11):3125-3137. doi: 10.1007/s00417-023-06071-8. Epub 2023 Jun 9.
Khanani AM, Guymer RH, Basu K, Boston H, Heier JS, Korobelnik JF, Kotecha A, Lin H, Silverman D, Swaminathan B, Willis JR, Yoon YH, Quezada-Ruiz C. TENAYA and LUCERNE: Rationale and Design for the Phase 3 Clinical Trials of Faricimab for Neovascular Age-Related Macular Degeneration. Ophthalmol Sci. 2021 Nov 17;1(4):100076. doi: 10.1016/j.xops.2021.100076. eCollection 2021 Dec.
Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-004042-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GR40844
Identifier Type: -
Identifier Source: org_study_id
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