Clinical trial NCT03823287: A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)
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 (TENAYA)
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: 671
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: Mesa
country: United States
facility: Barnet Dulaney Perkins Eye Center
state: Arizona
city: Phoenix
country: United States
facility: Retinal Research Institute, LLC
state: Arizona
city: Tucson
country: United States
facility: Retina Associates Southwest PC
state: Arizona
city: Campbell
country: United States
facility: Retinal Diagnostic Center
state: California
city: Encino
country: United States
facility: The Retina Partners
state: California
city: La Jolla
country: United States
facility: Jacobs Retina center at the Shiley eye Institute UCSD
state: California
city: Los Angeles
country: United States
facility: South Coast Retina Center
state: California
city: Palm Desert
country: United States
facility: Southern CA Desert Retina Cons
state: California
city: Pasadena
country: United States
facility: California Eye Specialists Medical group Inc.
state: California
city: Poway
country: United States
facility: Retina Consultants, San Diego
state: California
city: Redlands
country: United States
facility: Retina Consultants of Southern California
state: California
city: Sacramento
country: United States
facility: University of California, Davis, Eye Center
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern
state: Colorado
city: Waterford
country: United States
facility: Retina Group of New England
state: Connecticut
city: Deerfield Beach
country: United States
facility: Rand Eye
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Plantation
country: United States
facility: Fort Lauderdale Eye Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Assoc of FL
state: Florida
city: Chicago
country: United States
facility: Northwestern Medical Group/Northwestern University
state: Illinois
city: Lenexa
country: United States
facility: Retina Associates
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins Med; Wilmer Eye Inst
state: Maryland
city: Chevy Chase
country: United States
facility: Retina Group of Washington
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center; Ophthalmology
state: Massachusetts
city: Grand Rapids
country: United States
facility: Associated Retinal Consultants
state: Michigan
city: Chesterfield
country: United States
facility: Midwest Vision Research Foundation
state: Missouri
city: Florissant
country: United States
facility: Retina Associates of St. Louis
state: Missouri
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Edison
country: United States
facility: NJ Retina
state: New Jersey
city: Teaneck
country: United States
facility: Retina Associates of NJ
state: New Jersey
city: Hauppauge
country: United States
facility: Long Is. Vitreoretinal Consult
state: New York
city: Liverpool
country: United States
facility: Retina Vit Surgeons/Central NY
state: New York
city: Oceanside
country: United States
facility: Ophthalmic Cons of Long Island
state: New York
city: Rochester
country: United States
facility: Retina Assoc of Western NY
state: New York
city: Slingerlands
country: United States
facility: The Retina Consultants
state: New York
city: Asheville
country: United States
facility: Western Carolina Retinal Associate PA
state: North Carolina
city: Charlotte
country: United States
facility: Char Eye Ear &Throat Assoc
state: North Carolina
city: Hickory
country: United States
facility: Graystone Eye
state: North Carolina
city: Southern Pines
country: United States
facility: Carolina Eye Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Portland
country: United States
facility: Retina Northwest
state: Oregon
city: Philadelphia
country: United States
facility: Mid Atlantic Retina - Wills Eye Hospital
state: Pennsylvania
city: Ladson
country: United States
facility: Charleston Neuroscience Inst
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Eye Institute
state: South Dakota
city: Germantown
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Retina PC.
state: Tennessee
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Harlingen
country: United States
facility: Valley Retina Institute P.A.
state: Texas
city: Houston
country: United States
facility: Retina & Vitreous of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Salt Lake City
country: United States
facility: Rocky Mountain Retina
state: Utah
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
city: Calgary
country: Canada
facility: Calgary Retina Consultants
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia - Vancouver Coastal Health Authority
state: British Columbia
city: London
country: Canada
facility: Ivey Eye Institute
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Eye Institute
state: Ontario
city: Ottawa
country: Canada
facility: The Retina Centre of Ottawa
state: Ontario
city: Toronto
country: Canada
facility: Toronto Retina Institute
state: Ontario
city: Toronto
country: Canada
facility: Unity Health Toronto
state: Ontario
city: Boisbriand
country: Canada
facility: Institut De L'Oeil Des Laurentides
state: Quebec
city: Sherbrooke
country: Canada
facility: Michel Giunta Clinique Medical
state: Quebec
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde
city: Heidelberg
country: Germany
facility: Universitätsklinik Heidelberg; Augenklinik
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Budapest
country: Hungary
facility: Budapest Retina Associates Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
city: Pécs
country: Hungary
facility: Ganglion Medial Center
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Kórház; SZEMESZET
city: Haifa
country: Israel
facility: Rambam Medical Center; Opthalmology
city: Jerusalem
country: Israel
facility: Hadassah MC; Ophtalmology
city: Petach Tikva
country: Israel
facility: Rabin MC; Ophtalmology
city: Rehovot
country: Israel
facility: Kaplan Medical Center; Ophtalmology
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky MC; Ophtalmology
city: Roma
country: Italy
facility: Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
state: Lazio
city: Milano
country: Italy
facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
state: Lombardia
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica
state: Umbria
city: Aichi
country: Japan
facility: Chukyo Hospital
city: Aichi
country: Japan
facility: Nagoya University Hospital
city: Aichi
country: Japan
facility: Nagoya City University Hospital
city: Aichi
country: Japan
facility: Aichi Medical University Hospital
city: Aichi
country: Japan
facility: Daiyukai Daiichi Hospital
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Chiba
country: Japan
facility: Toho University Sakura Medical Center
city: Fukuoka
country: Japan
facility: Hayashi Eye Hospital
city: Fukuoka
country: Japan
facility: Kurume University Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Fukushima
country: Japan
facility: Southern TOHOKU Eye Clinic
city: Hokkaido
country: Japan
facility: Sapporo City General Hospital
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital
city: Hokkaido
country: Japan
facility: Asahikawa Medical University Hospital
city: Hyogo
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
city: Hyogo
country: Japan
facility: Hyogo Medical University Hospital
city: Ibaraki
country: Japan
facility: Kozawa eye hospital and diabetes center
city: Kagawa
country: Japan
facility: Kagawa University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kumamoto
country: Japan
facility: Ideta Eye Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Mie
country: Japan
facility: Mie University Hospital
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital
city: Nagano
country: Japan
facility: Shinshu University Hospital
city: Nagano
country: Japan
facility: Iida Municipal Hospital
city: Nagasaki
country: Japan
facility: Japanese Red Cross Nagasaki Genbaku Hospital
city: Nara
country: Japan
facility: Nara Medical University Hospital
city: Okinawa
country: Japan
facility: University of the Ryukyus Hospital
city: Osaka
country: Japan
facility: Kitano Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Osaka
country: Japan
facility: Kansai Medical University Medical Center
city: Osaka
country: Japan
facility: Kansai Medical University Hospital
city: Saitama
country: Japan
facility: National Defense Medical College Hospital
city: Shiga
country: Japan
facility: Shiga University Of Medical Science Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: Nihon University Hospital
city: Tokyo
country: Japan
facility: Takeuchi eye clinic
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
city: Yamaguchi
country: Japan
facility: Yamaguchi University Hospital
city: Del. Cuauhtemoc
country: Mexico
facility: Centro Oftalmológico Mira, S.C
state: Mexico CITY (federal District)
city: Mexico, D.F.
country: Mexico
facility: Macula Retina Consultores
city: Monterrey Nuevo LEON
country: Mexico
facility: Montemayor & Asociados (Oftalmologos)
city: Rotterdam
country: Netherlands
facility: Het Oogziekenhuis Rotterdam
city: Tilburg
country: Netherlands
facility: ETZ Elisabeth
city: Bielsko-Biala
country: Poland
facility: Szpital sw. Lukasza
city: Bydgoszcz
country: Poland
facility: Specjalistyczny Ośrodek Okulistyczny Oculomedica
city: Bytom
country: Poland
facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki
city: Gdańsk
country: Poland
facility: Dobry Wzrok Sp Z O O
city: Katowice
country: Poland
facility: Gabinet Okulistyczny Prof Edward Wylegala
city: Kraków
country: Poland
facility: Centrum Medyczne Dietla 19 Sp. Z O.O.
city: Wroclaw
country: Poland
facility: SPEKTRUM Osrodek Okulistyki Klinicznej
city: St.Petersburg
country: Russian Federation
facility: Medical Military Academy n.a S.M.Kirov
state: Sankt Petersburg
city: Kazan
country: Russian Federation
facility: Clinics of Eye Diseases, LLC
state: Tatarstan
city: Moscow
country: Russian Federation
facility: FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences
city: San Cugat Del Valles
country: Spain
facility: Hospital General de Catalunya
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia
state: LA Coruña
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia
state: Navarra
city: Burjassot
country: Spain
facility: Oftalvist Valencia
state: Valencia
city: Barcelona
country: Spain
facility: Hospital dos de maig; servicio de oftalmologia
city: Madrid
country: Spain
facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia
city: Madrid
country: Spain
facility: Clinica Baviera; Servicio Oftalmologia
city: Binningen
country: Switzerland
facility: Vista Klinik Ophthalmologische Klinik
city: Zürich
country: Switzerland
facility: Stadtspital Triemli Ophthalmologische Klinik
city: Ankara
country: Turkey
facility: Ankara Baskent University Medical Faculty; Department of Ophthalmology
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi Tıp Fakültesi; Department of Ophthalmology
city: Konya
country: Turkey
facility: Selcuk University Faculty of Medicine; Department Of Ophthalmology
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Bristol
country: United Kingdom
facility: Bristol Eye Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
city: York
country: United Kingdom
facility: The York Hospital
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.