A clinical trial to compare faricimab with aflibercept in people with neovascular age‑related macular degeneration. (Lucerne)

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

  • Eye Disorder
  • Wet Age‑Related Macular Degeneration
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Cities
  • aan
  • Abilene
  • Aiea
  • Albury
  • Ankara
  • Arizona
  • Augusta
  • Austin
  • Baltimore
  • Barcelona
  • Beachwood
  • bei-jing-shi
  • Beijing
  • Boston
  • Braga
  • Budapest
  • Buenos Aires
  • Busan
  • Bydgoszcz
  • chang-chun-shi
  • Changhua County
  • Chattanooga
  • Cheboksary
  • Cheng Du Shi
  • Chongqing
  • Coimbra
  • Columbus
  • Créteil
  • Daegu
  • DeSoto
  • Dublin
  • Düsseldorf
  • East Melbourne
  • Edina
  • Firenze
  • Fort Lauderdale
  • Gdańsk
  • Glostrup
  • Goiás
  • Graz
  • guang-zhou-shi
  • Hagerstown
  • Harbin
  • Hong Kong Island
  • Indianapolis
  • Irkutsk
  • İzmir
  • Kraków
  • Köln
  • L'Hospitalet de Llobregat
  • Lakewood
  • Lombardy
  • Lynchburg
  • Lyon
  • Marietta
  • Marseille
  • Mendoza
  • Mountain View
  • Murray
  • Münster
  • Nanjing
  • Nantes
  • Nedlands
  • Norfolk
  • Novosibirsk
  • Oak Forest
  • Oviedo
  • Palm Beach Gardens
  • Paris
  • Parramatta
  • Philadelphia
  • Phoenix
  • Pisa
  • Portland
  • Porto
  • Roma
  • Rosario
  • Roskilde
  • Rowville
  • Sacramento
  • Saint Petersburg
  • Saint-Cyr-sur-Loire
  • Santa Ana
  • Santa Barbara
  • Seongnam-si
  • Seoul
  • shang-hai-shi
  • shenandoah
  • Shenyang
  • Shirley
  • Silverdale
  • Singapore
  • Sofia
  • Southlake
  • Springfield
  • Strathfield
  • Sydney
  • Szeged
  • São Paulo
  • Taipei City
  • Tallahassee
  • Tampa
  • Taoyuan City
  • Tarnowskie Góry
  • tian-jin-shi
  • Toronto
  • Towson
  • Udine
  • Valladolid
  • wen-zhou-shi
  • West Des Moines
  • west-columbia
  • Westmead
  • Wien
  • Willow Park
  • wu-xi-shi
  • Zaragoza
  • Écully
Trial Identifier:

NCT03823300 2018-004042-42 GR40844

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

    149 Ulitsa L'va Tolstogo630008NovosibirskRussia
  • "Intersec. Research and Technology Complex "Eye Microsurgery" n a Fyodorov Irkutsk branch

    3 Ulitsa Bogdana Khmel'nitskogo664000IrkutskRussia
  • 1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology

    Saint PetersburgRussia
  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica

    50 Via Colugna33100UdineItaly
  • Ankara University Medical Faculty; Department of Ophthalmology

    12 Mamak Cd.06620AnkaraTürkiye
  • Arizona Retina and Vitreous Consultants

    3840 N 16th St85016PhoenixUnited States
  • Asan Medical Center.

    05505SeoulSouth Korea
  • Associated Retina Consultants

    1750 E Glendale Ave85020PhoenixUnited States
  • ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

    LombardyItaly
  • Augenabteilung am St. Franziskus-Hospital

    74 Hohenzollernring48145MünsterGermany
  • Austin Clinical Research LLC

    9707 Anderson Mill Rd78750AustinUnited States
  • Austin Retina Associates

    AustinUnited States
  • Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

    3 Largo Giovanni Alessandro Brambilla50134FirenzeItaly
  • Bajcsy-Zsilinszky Hospital

    89-91 Maglódi út1106BudapestHungary
  • Beijing Friendship Hospital

    36 永安路100052bei-jing-shiChina
  • Beijing Tongren Hospital

    BeijingChina
  • Buenos Aires Mácula

    Buenos AiresArgentina
  • California Retina Consultants

    525 E Micheltorena St93103Santa BarbaraUnited States
  • Caminomed

    3 Wyszyńskiego42-600Tarnowskie GóryPoland
  • Centre For Eye Research Australia

    200 Victoria Parade3002East MelbourneAustralia
  • Centre Odeon; Exploration Ophtalmologique

    122 Bd Saint-Germain75006ParisFrance
  • Centre Ophtalmologique; Imagerie et laser

    9 Rue Robert de Flers75015ParisFrance
  • Centre Paradis Monticelli; Ophtalmologie

    433 Rue Paradis13008MarseilleFrance
  • Centres Ophtalmologique St Exupéry; Ophtalmologie

    37540Saint-Cyr-sur-LoireFrance
  • Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia

    3004-561CoimbraPortugal
  • Centro Oftalmológico Dr. Charles S.A.

    841 RiobambaC1116Buenos AiresArgentina
  • Chang Gung Medical Foundation - Linkou; Ophthalmology

    259號 Wenhua 1st Rd333Taoyuan CityTaiwan
  • Changhua Christian Hospital; Department of Ophthalmology

    176 Zhonghua Rd500Changhua CountyTaiwan
  • Chi De Creteil; Ophtalmologie

    40 Av. de Verdun94000CréteilFrance
  • CHU Nantes - Hôtel Dieu; Ophthalmology

    1 Pl. Alexis-Ricordeau44000NantesFrance
  • Colorado Retina Associates, PC

    255 S Routt Way80228LakewoodUnited States
  • Cumberland Valley Retina PC

    1150 Opal Ct21740HagerstownUnited States
  • Daping Hospital of Third Military Medical University

    400042ChongqingChina
  • Ege University Medical Faculty; Department of Ophthalmology

    35100İzmirTürkiye
  • Eye Hospital, Wenzhou Medical University

    270 Xue Yuan Xi Lu325027wen-zhou-shiChina
  • Eyeclinic Albury Wodonga

    669 Dean St2640AlburyAustralia
  • Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

    81 Viale Oxford00133RomaItaly
  • Fundacion Zambrano

    1023Buenos AiresArgentina
  • Gazi University Faculty of Medicine; Department Of Ophthalmology

    37 Dögol Cd.06570AnkaraTürkiye
  • Georgia Retina PC

    MariettaUnited States
  • Grupo Laser Vision

    RosarioArgentina
  • Hacettepe University Medical Faculty; Department of Ophthalmology

    AnkaraTürkiye
  • He Eye Specialist Shenyang Hospital

    110034ShenyangChina
  • Hong Kong Eye Hospital; CUHK Eye Centre

    147K Argyle StTorontoHong Kong
  • Hopital de la croix rousse; Ophtalmologie

    103 Gd Rue de la Croix-Rousse69004LyonFrance
  • Hopital Lariboisiere; Ophtalmologie

    2 Rue Ambroise Paré75010ParisFrance
  • Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

    170 C. de Villarroel08036BarcelonaSpain
  • Hospital de Braga; Servico de Oftalmologia

    4710-243BragaPortugal
  • Hospital de Olhos de Aparecida - HOA

    S/n Av. Dom Abel Ribeiro74980-010GoiásBrazil
  • Hospital de Sao Joao; Servico de Oftalmologia

    4200-319PortoPortugal
  • Hospital Universitario de Bellvitge

    s/n Carrer de la Feixa Llarga08907L'Hospitalet de LlobregatSpain
  • Hospital Universitario Miguel Servet; Servicio de Oftalmologia

    1-3 P.º de Isabel la Católica50009ZaragozaSpain
  • Hospital Universitario Rio Hortega; Servicio de Oftalmologia

    2 C. Dulzaina47012ValladolidSpain
  • Institut de la Macula i la retina

    12 Carrer de Vilana08022BarcelonaSpain
  • Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia

    34 Av. Doctores Fernández Vega33012OviedoSpain
  • Intersec Research and Technology Complex "Eye Microsurgery" n.a. S.N. Fyodorov; Cheboksary Branch

    CheboksaryRussia
  • Island Retina

    60 Northern Blvd11967ShirleyUnited States
  • Kyung Hee University Hospital

    130-050SeoulSouth Korea
  • LKH-Univ.Klinikum Graz; Universitäts-Augenklinik

    1 Auenbruggerpl.8036GrazAustria
  • Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály

    111 Podmaniczky u.1062BudapestHungary
  • Maine Eye Center

    161 Marginal Way04101PortlandUnited States
  • Marsden Eye Research Centre

    152 Marsden St2150ParramattaAustralia
  • Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

    18-20 Währinger Gürtel1090WienAustria
  • Mid Atlantic Retina - Wills Eye Hospital

    840 Walnut St19107PhiladelphiaUnited States
  • Midwest Retina

    6655 Post Rd43016DublinUnited States
  • National University Hospital; Ophthalmology Department

    5 Lower Kent Ridge Rd119074SingaporeSingapore
  • Northern California Retina Vitreous Associates

    2495 Hospital Dr94040Mountain ViewUnited States
  • Nune Eye Hospital; Ophthalmology

    06212SeoulSouth Korea
  • OFTALMIKA Sp. z o.o

    45 Kazimierza Pułaskiego85-619BydgoszczPoland
  • Oftalmos

    1832 Av. CórdobaC1120aanArgentina
  • Oftar

    MendozaArgentina
  • Ophthalmic Consultants of Boston

    50 Staniford St02114BostonUnited States
  • Optimum Profesorskie Centrum Okulistyki

    30 Cienista80-809GdańskPoland
  • Orange County Retina Med Group

    999 N Tustin Ave92705Santa AnaUnited States
  • Organizacion Medica de Investigacion

    725 UruguayC1015Buenos AiresArgentina
  • Palmetto Retina Center

    124 Sunset Ct29169west-columbiaUnited States
  • Peking Union Medical College Hospital

    41 大木仓胡同100032bei-jing-shiChina
  • Pentagram Eye Hospital (Medical Center "Pentagram")

    109 ul. "Vranya"1309SofiaBulgaria
  • Piedmont Eye Center

    116 Nationwide Dr24502LynchburgUnited States
  • Pole Vision Val d'Ouest; Ophtalmologie

    39 Chem. de la Vernique69130ÉcullyFrance
  • Prairie Retina Center

    2800 Montaluma Dr62704SpringfieldUnited States
  • Pusan National University Hospital

    BusanSouth Korea
  • Queen Mary Hospital; Department of Ophthalmology

    102 Pok Fu Lam RdHong Kong IslandHong Kong
  • Raj K. Maturi, MD PC

    10300 Illinois St46290IndianapolisUnited States
  • Retina Assoc of Cleveland Inc

    24075 Commerce Park Rd44122BeachwoodUnited States
  • Retina Associates of Florida, LLC

    602 S MacDill Ave33609TampaUnited States
  • Retina Associates of Utah

    5169 S Cottonwood St84107MurrayUnited States
  • Retina Care Specialists

    3399 PGA Boulevard33410Palm Beach GardensUnited States
  • Retina Center Northwest

    9800 Levin Rd NW98383SilverdaleUnited States
  • Retina Center of Texas

    305 Morrison Park Dr76092SouthlakeUnited States
  • Retina Consultants of Hawaii

    98-1079 Moanalua Rd96701AieaUnited States
  • Retina Consultants of Houston

    77384shenandoahUnited States
  • Retina Group of Florida

    6333 N Federal Hwy33308Fort LauderdaleUnited States
  • Retina Res Institute of Texas

    79606AbileneUnited States
  • Retina Specialists

    6569 MD-13921204TowsonUnited States
  • Retina Specialists

    2625 Bolton Boone Dr75115DeSotoUnited States
  • Retina Specialists Victoria

    1091 Stud Rd3178RowvilleAustralia
  • Retinal Consultants Med Group

    5775 Greenback Ln95841SacramentoUnited States
  • Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning

    13 Valdemar Hansens Vej2600GlostrupDenmark
  • Samsung Medical Center

    06351SeoulSouth Korea
  • Seoul National University Bundang Hospital

    13620Seongnam-siSouth Korea
  • Seoul National University Hospital

    03080SeoulSouth Korea
  • Shanghai First People's Hospital

    100 Hai Ning Lu200081shang-hai-shiChina
  • Singapore Eye Research Institute

    20 College Rd169856SingaporeSingapore
  • Sjællands Universitetshospital, Roskilde; Øjenafdelingen

    23 Vestermarksvej4000RoskildeDenmark
  • Southeast Retina Center

    3685 Wheeler Rd30909AugustaUnited States
  • Southeastern Retina Associates Chattanooga

    1606 Gunbarrel Rd37421ChattanoogaUnited States
  • Southern Vitreoretinal Assoc

    2439 Care Dr32308TallahasseeUnited States
  • Southwest Hospital , Third Military Medical University; Ophthalmology

    ChongqingChina
  • SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

    38 Mikołaja Kopernika31-501KrakówPoland
  • Specialized Hospital for Active Treatment of Eye Diseases Zora

    20 bul. „Andrej Sakharov“1000SofiaBulgaria
  • Strategic Clinical Research Group, LLC

    Willow ParkUnited States
  • Strathfield Retina Clinic

    9-13 Redmyre Rd2135StrathfieldAustralia
  • Sydney Eye Hospital

    8 Macquarie St2000SydneyAustralia
  • Sydney Retina Clinic and Day Surgery

    187 Macquarie St2000SydneyAustralia
  • Sydney West Retina

    2145WestmeadAustralia
  • Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

    10-11 Korányi fasor6720SzegedHungary
  • Taipei Veterans General Hospital; Ophthalmology

    201號 Section 2, Shipai Rd112Taipei CityTaiwan
  • The Affiliated Eye Hospital of Nanjing Medical University

    NanjingChina
  • The Lions Eye Institute

    6009NedlandsAustralia
  • The Ohio State University Havener Eye Institute

    915 Olentangy River Rd43212ColumbusUnited States
  • The Retina Care Center

    6115 Falls Rd21209BaltimoreUnited States
  • The Second Affiliated Hospital of Harbin Medical University; ophthalmology department

    HarbinChina
  • The Second Hospital of Jilin University; ophthalmology department

    218 自强街130041chang-chun-shiChina
  • Tianjin Eye Hospital

    4 Gan Su Lu300020tian-jin-shiChina
  • Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

    862 R. Botucatu04023-062São PauloBrazil
  • UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

    16132ArizonaItaly
  • Universitätkslinikum Düsseldorf, Augenklinik; Klinik fürAugenheilkunde

    5 Moorenstraße40225DüsseldorfGermany
  • Universitätsklinikum Köln; Augenklinik

    62 Kerpener Str.50937KölnGermany
  • Universitätsklinikum Münster; Augenheilkunde

    15 Domagkstraße48149MünsterGermany
  • University Retina and Macula Associates, PC

    6320 W 159th St60452Oak ForestUnited States
  • VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

    3601 W 76th St55435EdinaUnited States
  • Wagner Macula & Retina Center

    23502NorfolkUnited States
  • West China Hospital, Sichuan University

    37 Guo Xue Xiang610041Cheng Du ShiChina
  • Wolfe Eye Clinic

    50266West Des MoinesUnited States
  • Wuxi No.2 People's Hospital

    68 Zhong Shan Lu214002wu-xi-shiChina
  • Yeungnam University Medical Center

    42415DaeguSouth Korea
  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    510062guang-zhou-shiChina
    Show study locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Study 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).

    Hoffmann-La Roche Sponsor
    Phase 3 Phase
    NCT03823300, GR40844, 2018-004042-42 Study Identifier
    All Gender
    ≥50 Years Age
    No Healthy Volunteers

    How does the LUCERNE clinical trial work?
    This clinical trial is recruiting people who have a type of eye disease called neovascular age-related macular degeneration, or nAMD.

    The purpose of this clinical trial is to compare the effects, good or bad, of faricimab versus aflibercept in patients with nAMD. In this clinical trial, you will get either faricimab or aflibercept as treatment.

    How do I take part in this clinical trial?
    To be able to take part in this clinical trial, you must have been diagnosed with nAMD.

    If you have previously been treated for nAMD in the study eye or been given faricimab in either eye, have uncontrolled blood pressure or other eye related problems, you will not be able to join the trial.

    If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

    You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.

    Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.

    While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons.

    What treatment will I be given if I join this clinical trial?
    Everyone who joins this clinical trial will be split into 1 of 2 groups randomly (like flipping a coin) and given either:

    • faricimab, given as an injection into your eye (the time between injections will be based on how your disease responds to the treatment and will vary throughout the trial)
    • OR aflibercept, given as an injection into your eye every 4 weeks for the first 3 months, and then every 8 weeks until the end of the trial

    You will have an equal chance of being placed in any group. Only one eye will be treated during the study. If you have nAMD in both eyes, the eye that has the worst vision will be treated with the clinical trial drug and you will be given the current standard treatment for your other eye.

    Neither you nor your clinical trial doctor can choose or know the group you are in. However, your clinical trial doctor can find out which group you are in, if your safety is at risk. You will have to see the clinical trial doctor every 4 weeks. As the times between treatments are different for each group, you will have to have a sham treatment during the visits where you do not need your treatment to make sure that nobody knows which group you are in.

    How often will I be seen in follow-up appointments, and for how long?
    You will be given the clinical trial treatment faricimab OR aflibercept for just over 2 years (108 weeks). You are free to stop this treatment at any time. After being given your last treatment, you will be seen once more by the clinical trial doctor after 4 weeks. This hospital visit will include checks to see how you are responding to the treatment and monitor any side effects that you may be having.

    What happens if I am unable to take part in this clinical trial?
    If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

    For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov

    Trial-identifier: NCT03823300

    Study 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).

    Hoffmann-La Roche Sponsor
    Phase 3 Phase
    NCT03823300, GR40844, 2018-004042-42 Trial Identifier
    Faricimab, Aflibercept, Sham Procedure Treatments
    Wet Macular Degeneration Condition
    Official Title

    A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (LUCERNE)

    Eligibility Criteria

    All Gender
    ≥50 Years Age
    No Healthy Volunteers
    Inclusion Criteria
    • 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
    • Other protocol-specified inclusion criteria may apply
    Exclusion Criteria
    • 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
    • Other protocol-specified exclusion criteria may apply

    About Clinical Research

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