Clinical trial NCT03823300: A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wet Macular Degeneration
Keywords: AMD
nAMD
neovascular age-related macular degeneration
choroidal neovascularization secondary to age-related macular degeneration
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2019-01-30
Enrollment: 658
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
timeFrame: From Baseline through Week 48
Secondary outcomes:
measure: Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
timeFrame: From Baseline through Week 60
measure: Change From Baseline in BCVA in the Study Eye Over Time
timeFrame: 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
measure: 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
timeFrame: Baseline, average of Weeks 40, 44, and 48
measure: Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
timeFrame: Baseline, average of Weeks 52, 56, and 60
measure: Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
timeFrame: 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
measure: Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
timeFrame: 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
measure: Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
timeFrame: 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
measure: Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
timeFrame: 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
measure: Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
timeFrame: Baseline, average of Weeks 40, 44, and 48
measure: Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
timeFrame: Baseline, average of Weeks 52, 56, and 60
measure: Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
timeFrame: 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
measure: Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
timeFrame: 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
measure: Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
timeFrame: 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
measure: Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48
timeFrame: Baseline, average of Weeks 40, 44, and 48
measure: Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
timeFrame: 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
measure: Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48
timeFrame: Baseline, average of Weeks 40, 44, and 48
measure: Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
timeFrame: 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
measure: Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48
timeFrame: Baseline, average of Weeks 40, 44, and 48
measure: Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
timeFrame: 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
measure: Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48
timeFrame: Week 48
measure: Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60
timeFrame: Week 60
measure: Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112
timeFrame: Weeks 108 and 112
measure: Number of Study Drug Injections Received in the Study Eye Through Week 48
timeFrame: From Baseline through Week 48
measure: Number of Study Drug Injections Received in the Study Eye Through Week 60
timeFrame: From Baseline through Week 60
measure: Number of Study Drug Injections Received in the Study Eye Through Week 108
timeFrame: From Baseline through Week 108
measure: Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48
timeFrame: From Baseline through Week 48
measure: Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60
timeFrame: From Baseline through Week 60
measure: Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
timeFrame: 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
measure: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
measure: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
measure: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
measure: Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112
measure: Percentage of Participants With Absence of Intraretinal Cysts in the Study Eye Over Time
timeFrame: Up to 112 weeks
measure: Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48
timeFrame: Baseline and Week 48
measure: Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 112
timeFrame: Baseline and Week 112
measure: Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 48
timeFrame: Baseline and Week 48
measure: Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 112
timeFrame: Baseline and Week 112
measure: Percentage of Participants With at Least One Adverse Event
timeFrame: From first dose of study drug through end of study (up to 112 weeks)
measure: Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
timeFrame: From first dose of study drug through end of study (up to 112 weeks)
measure: Percentage of Participants With at Least One Non-Ocular Adverse Event
timeFrame: From first dose of study drug through end of study (up to 112 weeks)
measure: Plasma Concentration of Faricimab Over Time
timeFrame: Pre-dose at Baseline, Weeks 4, 16, 20, 48, 76, and 112
measure: Percentage of Participants Who Tested Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study
timeFrame: Pre-dose at Baseline, Weeks 4, 20, 48, 76, and 112
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Phoenix
country: United States
facility: Arizona Retina and Vitreous Consultants
state: Arizona
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Med Group
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Med Group
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Lakewood
country: United States
facility: Colorado Retina Associates, PC
state: Colorado
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Palm Beach Gardens
country: United States
facility: Retina Care Specialists
state: Florida
city: Tallahassee
country: United States
facility: Southern Vitreoretinal Assoc
state: Florida
city: Tampa
country: United States
facility: Retina Associates of Florida, LLC
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Marietta
country: United States
facility: Georgia Retina PC
state: Georgia
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
city: Oak Forest
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
city: Springfield
country: United States
facility: Prairie Retina Center
state: Illinois
city: Indianapolis
country: United States
facility: Raj K. Maturi, MD PC
state: Indiana
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Portland
country: United States
facility: Maine Eye Center
state: Maine
city: Baltimore
country: United States
facility: The Retina Care Center
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina PC
state: Maryland
city: Towson
country: United States
facility: Retina Specialists
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Edina
country: United States
facility: VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
state: Minnesota
city: Shirley
country: United States
facility: Island Retina
state: New York
city: Cleveland
country: United States
facility: Retina Assoc of Cleveland Inc
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Havener Eye Institute
state: Ohio
city: Dublin
country: United States
facility: Midwest Retina
state: Ohio
city: Philadelphia
country: United States
facility: Mid Atlantic Retina - Wills Eye Hospital
state: Pennsylvania
city: West Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Chattanooga
country: United States
facility: Southeastern Retina Associates Chattanooga
state: Tennessee
city: Abilene
country: United States
facility: Retina Res Institute of Texas
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research LLC
state: Texas
city: DeSoto
country: United States
facility: Retina Specialists
state: Texas
city: Southlake
country: United States
facility: Retina Center of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Retina Associates of Utah
state: Utah
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Norfolk
country: United States
facility: Wagner Macula & Retina Center
state: Virginia
city: Silverdale
country: United States
facility: Retina Center Northwest
state: Washington
city: Caba
country: Argentina
facility: Fundacion Zambrano
city: Capital Federal
country: Argentina
facility: Centro Oftalmológico Dr. Charles S.A.
city: Capital Federal
country: Argentina
facility: Oftalmos
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Buenos Aires Mácula
city: Mendoza
country: Argentina
facility: Oftar
city: Rosario
country: Argentina
facility: Grupo Laser Vision
city: San Nicolás
country: Argentina
facility: Organizacion Medica de Investigacion
city: Albury
country: Australia
facility: Eyeclinic Albury Wodonga
state: New South Wales
city: Parramatta
country: Australia
facility: Marsden Eye Research Centre
state: New South Wales
city: Strathfield
country: Australia
facility: Strathfield Retina Clinic
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Eye Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Retina Clinic and Day Surgery
state: New South Wales
city: Westmead
country: Australia
facility: Sydney West Retina
state: New South Wales
city: East Melbourne
country: Australia
facility: Centre For Eye Research Australia
state: Victoria
city: Rowville
country: Australia
facility: Retina Specialists Victoria
state: Victoria
city: Nedlands
country: Australia
facility: The Lions Eye Institute
state: Western Australia
city: Graz
country: Austria
facility: LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
city: Wien
country: Austria
facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
city: Aparecida de Goiania
country: Brazil
facility: Hospital de Olhos de Aparecida - HOA
state: GO
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
state: SP
city: Sofia
country: Bulgaria
facility: Pentagram Eye Hospital (Medical Center "Pentagram")
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Eye Diseases Zora
city: Beijing City
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Beijing
country: China
facility: Beijing Tongren Hospital
city: Changchun City
country: China
facility: The Second Hospital of Jilin University; ophthalmology department
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing City
country: China
facility: Southwest Hospital , Third Military Medical University; Ophthalmology
city: Chongqing
country: China
facility: Daping Hospital of Third Military Medical University
city: Guangzhou City
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University; ophthalmology department
city: Nanjing City
country: China
facility: The Affiliated Eye Hospital of Nanjing Medical University
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Shenyang City
country: China
facility: He Eye Specialist Shenyang Hospital
city: Tianjin City
country: China
facility: Tianjin Eye Hospital
city: Wenzhou City
country: China
facility: Eye Hospital, Wenzhou Medical University
city: Wuxi
country: China
facility: Wuxi No.2 People's Hospital
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen
city: Creteil
country: France
facility: Chi De Creteil; Ophtalmologie
city: Ecully
country: France
facility: Pole Vision Val d'Ouest; Ophtalmologie
city: Lyon cedex
country: France
facility: Hopital de la croix rousse; Ophtalmologie
city: Marseille
country: France
facility: Centre Paradis Monticelli; Ophtalmologie
city: Nantes
country: France
facility: CHU Nantes - Hôtel Dieu; Ophthalmology
city: Paris
country: France
facility: Centre Odeon; Exploration Ophtalmologique
city: Paris
country: France
facility: Hopital Lariboisiere; Ophtalmologie
city: Paris
country: France
facility: Centre Ophtalmologique; Imagerie et laser
city: St Cyr Sur Loire
country: France
facility: Centres Ophtalmologique St Exupéry; Ophtalmologie
city: Düsseldorf
country: Germany
facility: Universitätkslinikum Düsseldorf, Augenklinik; Klinik fürAugenheilkunde
city: Köln
country: Germany
facility: Universitätsklinikum Köln; Augenklinik
city: Münster
country: Germany
facility: Augenabteilung am St. Franziskus-Hospital
city: Münster
country: Germany
facility: Universitätsklinikum Münster; Augenheilkunde
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital; Department of Ophthalmology
city: Mongkok
country: Hong Kong
facility: Hong Kong Eye Hospital; CUHK Eye Centre
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Hospital
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology
city: Roma
country: Italy
facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
state: Lazio
city: Genova
country: Italy
facility: UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA
state: Liguria
city: Milano
country: Italy
facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
state: Lombardia
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
state: Toscana
city: Pisa
country: Italy
facility: Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria
state: Toscana
city: Udine
country: Italy
facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
state: Veneto
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Nune Eye Hospital; Ophthalmology
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center.
city: Bydgoszcz
country: Poland
facility: OFTALMIKA Sp. z o.o
city: Gdańsk
country: Poland
facility: Optimum Profesorskie Centrum Okulistyki
city: Krakow
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
city: Tarnowskie Góry
country: Poland
facility: Caminomed
city: Braga
country: Portugal
facility: Hospital de Braga; Servico de Oftalmologia
city: Coimbra
country: Portugal
facility: Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia
city: Porto
country: Portugal
facility: Hospital de Sao Joao; Servico de Oftalmologia
city: Cheboksary
country: Russian Federation
facility: Intersec Research and Technology Complex "Eye Microsurgery" n.a. S.N. Fyodorov; Cheboksary Branch
state: Marij EL
city: Irkutsk
country: Russian Federation
facility: "Intersec. Research and Technology Complex "Eye Microsurgery" n a Fyodorov Irkutsk branch
city: Novosibirsk
country: Russian Federation
facility: "Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch
city: Saint Petersburg
country: Russian Federation
facility: 1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology
city: Singapore
country: Singapore
facility: National University Hospital; Ophthalmology Department
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute
city: Oviedo
country: Spain
facility: Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia
state: Asturias
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Institut de la Macula i la retina
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet; Servicio de Oftalmologia
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital; Department of Ophthalmology
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital; Ophthalmology
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou; Ophthalmology
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty; Department of Ophthalmology
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty; Department of Ophthalmology
city: Ankara
country: Turkey
facility: Gazi University Faculty of Medicine; Department Of Ophthalmology
city: Izmir
country: Turkey
facility: Ege University Medical Faculty; Department of Ophthalmology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.