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

NCT03823300 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: GR408442018-004042-42
• Study Type: interventional
• Target: 658
• Locations: 20 countries
• Sites: 128

Brief Summary

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

Conditions

Wet Macular Degeneration

Keywords

AMD; nAMD; neovascular age-related macular degeneration; choroidal neovascularization secondary to age-related macular degeneration

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

  Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (\<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded from analysis. 95% CI is a rounding of 95.03% CI.

  From Baseline through Week 48

Secondary Outcomes (42)

• Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

  From Baseline through Week 60

• Change From Baseline in BCVA in the Study Eye Over Time

  Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112

• Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

  Baseline, average of Weeks 40, 44, and 48

• Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

  Baseline, average of Weeks 52, 56, and 60

• Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time

  Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112

Study Arms (2)

Arm A: Faricimab

EXPERIMENTAL

Drug: Faricimab; Procedure: Sham Procedure

Arm B: Aflibercept

ACTIVE COMPARATOR

Drug: Aflibercept; Procedure: Sham Procedure

Interventions

Faricimab DRUG

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

Also known as: VABYSMO™, RO6867461, RG7716

Arm A: Faricimab

Aflibercept DRUG

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).

Also known as: Eylea

Arm B: Aflibercept

Sham Procedure 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 A: Faricimab; Arm B: Aflibercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye
• 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

You may not qualify if:

• Uncontrolled blood pressure, defined as systolic blood pressure \>180 millimeters of mercury (mmHg) and/or diastolic blood pressure \>100 mmHg while a patient is at rest on Day 1
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (137)

Associated Retina Consultants

Phoenix, Arizona, 85020, United States

Location

Arizona Retina and Vitreous Consultants

Phoenix, Arizona, 85021, United States

Location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

Retinal Consultants Med Group

Sacramento, California, 95825, United States

Location

Orange County Retina Med Group

Santa Ana, California, 92705, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

Colorado Retina Associates, PC

Golden, Colorado, 80401, United States

Location

Retina Group of Florida

Fort Lauderdale, Florida, 33308, United States

Location

Retina Care Specialists

Palm Beach Gardens, Florida, 33410, United States

Location

Southern Vitreoretinal Assoc

Tallahassee, Florida, 32308, United States

Location

Retina Associates of Florida, LLC

Tampa, Florida, 33609, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Georgia Retina PC

Marietta, Georgia, 30060, United States

Location

Retina Consultants of Hawaii

‘Aiea, Hawaii, 96701, United States

Location

University Retina and Macula Associates, PC

Oak Forest, Illinois, 60452, United States

Location

Prairie Retina Center

Springfield, Illinois, 62704, United States

Location

Raj K. Maturi, MD PC

Indianapolis, Indiana, 46290, United States

Location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Maine Eye Center

Portland, Maine, 04101, United States

Location

The Retina Care Center

Baltimore, Maryland, 21209, United States

Location

Cumberland Valley Retina PC

Hagerstown, Maryland, 21740, United States

Location

Retina Specialists

Towson, Maryland, 21204, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

VitreoRetinal Surgery, PLLC.

Minneapolis, Minnesota, 55435, United States

Location

Mid Atlantic Retina - Wills Eye Hospital

Cherry Hill, New Jersey, 08034, United States

Location

Island Retina

Shirley, New York, 11967, United States

Location

Retina Assoc of Cleveland Inc

Cleveland, Ohio, 44122, United States

Location

The Ohio State University Havener Eye Institute

Columbus, Ohio, 43212, United States

Location

Midwest Retina

Dublin, Ohio, 43016, United States

Location

Palmetto Retina Center

West Columbia, South Carolina, 29169, United States

Location

Southeastern Retina Associates Chattanooga

Chattanooga, Tennessee, 37421, United States

Location

Retina Res Institute of Texas

Abilene, Texas, 79606, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Austin Clinical Research LLC

Austin, Texas, 78750, United States

Location

Retina Center of Texas

Grapevine, Texas, 76051, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

Strategic Clinical Research Group, LLC

Willow Park, Texas, 76087, United States

Location

Retina Associates of Utah, PLLC

Murray, Utah, 84107, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Wagner Kapoor Institute

Norfolk, Virginia, 23502, United States

Location

Pacific Northwest Retina

Silverdale, Washington, 98383, United States

Location

Organizacion Medica de Investigacion

Buenos Aires, C1015ABO, Argentina

Location

Fundacion Zambrano

CABA, 1023, Argentina

Location

Centro Oftalmológico Dr. Charles S.A.

Capital Federal, C1116, Argentina

Location

Oftalmos

Capital Federal, C1120AAN, Argentina

Location

Buenos Aires Mácula

Ciudad Autonoma Buenos Aires, C1061AAE, Argentina

Location

Oftar

Mendoza, M5500GGK, Argentina

Location

Grupo Laser Vision

Rosario, S2000DLA, Argentina

Location

Eyeclinic Albury Wodonga

Albury, New South Wales, 2640, Australia

Location

Marsden Eye Research Centre

Parramatta, New South Wales, 2150, Australia

Location

Strathfield Retina Clinic

Strathfield, New South Wales, 2135, Australia

Location

Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

Location

Sydney Retina Clinic and Day Surgery

Sydney, New South Wales, 2000, Australia

Location

Sydney West Retina

Westmead, New South Wales, 2145, Australia

Location

Centre For Eye Research Australia

East Melbourne, Victoria, 3002, Australia

Location

Retina Specialists Victoria

Rowville, Victoria, 3178, Australia

Location

The Lions Eye Institute

Nedlands, Western Australia, 6009, Australia

Location

LKH-Univ.Klinikum Graz

Graz, 8036, Austria

Location

Medizinische Universität Wien

Vienna, 1090, Austria

Location

Hospital de Olhos de Aparecida - HOA

Aparecida de Goiânia, Goiás, 74980-010, Brazil

Location

Universidade Federal de Sao Paulo - UNIFESP*X

São Paulo, São Paulo, 04023-062, Brazil

Location

Specialized Hospital for Active Treatment of Eye Diseases Zora

Sofia, 1233, Bulgaria

Location

Pentagram Eye Hospital (Medical Center "Pentagram")

Sofia, 1309, Bulgaria

Location

Beijing Friendship Hospital

Beijing, 100050, China

Location

Beijing Tongren Hospital

Beijing, 100730, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

The Second Hospital of Jilin University

Changchun, 130041, China

Location

West China Hospital, Sichuan University

Chengdu, 610041, China

Location

Southwest Hospital , Third Military Medical University

Chongqing, 400014, China

Location

Army Medical Center of PLA(Daping Hospital)

Chongqing, 400042, China

Location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, 510060, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, 150081, China

Location

The Affiliated Eye Hospital of Nanjing Medical University

Nanjing, 210029, China

Location

Shanghai First People's Hospital

Shanghai, 200080, China

Location

He Eye Specialist Shenyang Hospital

Shenyang, 110034, China

Location

Tianjin Eye Hospital

Tianjin, 300050, China

Location

Eye Hospital, Wenzhou Medical University

Wenzhou, 325027, China

Location

Wuxi No.2 People's Hospital

Wuxi, 214000, China

Location

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

Location

Sjællands Universitetshospital, Roskilde

Roskilde, 4000, Denmark

Location

Chi De Creteil

Créteil, 94010, France

Location

Pole Vision Val d'Ouest

Écully, 69130, France

Location

Hopital de la croix rousse

Lyon, 69317, France

Location

Centre Paradis Monticelli

Marseille, 13008, France

Location

CHU Nantes - Hôtel Dieu

Nantes, 44093, France

Location

Centre Odeon

Paris, 75006, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

Centre Ophtalmologique

Paris, 75015, France

Location

Centres Ophtalmologique St Exupéry

Saint-Cyr-sur-Loire, 37540, France

Location

Universitätsklinikum Köln

Cologne, 50937, Germany

Location

Universitätkslinikum Düsseldorf, Augenklinik

Düsseldorf, 40225, Germany

Location

Augenabteilung am St. Franziskus-Hospital

Münster, 48145, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

The University of Hong Kong

Hong Kong, Hong Kong

Location

Hong Kong Eye Hospital

Mong Kok, Hong Kong

Location

Bajcsy-Zsilinszky Hospital

Budapest, 1106, Hungary

Location

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, 1134, Hungary

Location

Szegedi Tudományegyetem ÁOK

Szeged, 6720, Hungary

Location

Fondazione Ptv Policlinico Tor Vergata Di Roma

Rome, Lazio, 00133, Italy

Location

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

Genoa, Liguria, 16132, Italy

Location

Asst Fatebenefratelli Sacco

Milan, Lombardy, 20157, Italy

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello

Pisa, Tuscany, 56124, Italy

Location

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

Udine, Veneto, 33100, Italy

Location

OFTALMIKA Sp. z o.o

Bydgoszcz, 85-631, Poland

Location

Optimum Profesorskie Centrum Okulistyki

Gdansk, 80-809, Poland

Location

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

Krakow, 31-501, Poland

Location

Caminomed

Tarnowskie Góry, 42-600, Poland

Location

Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia

Coimbra, 3000-075, Portugal

Location

Hospital de Sao Joao

Porto, 4200-319, Portugal

Location

Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov

Cheboksary, Mariy-El Republic, 428000, Russia

Location

1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov

Saint Petersburg, Sankt-Peterburg, 197022, Russia

Location

?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch

Irkutsk, 664033, Russia

Location

?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch

Novosibirsk, 630096, Russia

Location

National University Hospital

Singapore, 119074, Singapore

Location

Singapore Eye Research Institute

Singapore, 168751, Singapore

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Nune Eye Hospital

Seoul, 06192, South Korea

Location

Asan Medical Center.

Seoul, 138-736, South Korea

Location

Samsung Medical Center

Seoul, 6351, South Korea

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Instituto Oftalmologico Fernandez Vega

Oviedo, Principality of Asturias, 33012, Spain

Location

Institut de la Macula i la retina

Barcelona, 08022, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08028, Spain

Location

Hospital Universitario Rio Hortega

Valladolid, 47012, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Chang Gung Medical Foundation - Linkou

Taoyuan District, 333, Taiwan

Location

Hacettepe University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Ankara University Medical Faculty

Ankara, 06340, Turkey (Türkiye)

Location

Gazi University Faculty of Medicine

Ankara, 06560, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 38382813 RESULT

• 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.

  PMID: 37294433 DERIVED

• 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.

  PMID: 36246941 DERIVED

• 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.

  PMID: 35085502 DERIVED

MeSH Terms

Conditions

Wet Macular Degeneration

Interventions

faricimab; aflibercept

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 30, 2019
• Study Start: March 11, 2019
• Primary Completion: October 5, 2020
• Study Completion: January 7, 2022
• Last Updated: July 11, 2025
• Results First Posted: May 4, 2022

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

ES (6); TU (4); CN (15); DE (4); RU (4); PT (2); KR (8); TW (3); US (41); SG (2); IT (6); HU (3); BU (2); PL (4); AR (7); HK (2); AU (2); DK (2); FR (9); BR (2)