A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)
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)
2 other identifiers
interventional
671
15 countries
161
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2019
Typical duration for phase_3
161 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2019
CompletedFirst Posted
Study publicly available on registry
January 30, 2019
CompletedStudy Start
First participant enrolled
February 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2022
CompletedResults Posted
Study results publicly available
May 4, 2022
CompletedJuly 23, 2025
July 1, 2025
1.7 years
January 29, 2019
February 25, 2022
July 2, 2025
Conditions
Keywords
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
- +37 more secondary outcomes
Study Arms (2)
Faricimab
EXPERIMENTALAflibercept
ACTIVE COMPARATORInterventions
Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
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).
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 treatments arms at applicable visits to maintain masking.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (161)
Retinal Research Institute, LLC
Phoenix, Arizona, 85014, United States
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, 85016, United States
Retina Associates Southwest PC
Tucson, Arizona, 85704, United States
Retinal Diagnostic Center
Campbell, California, 95008, United States
The Retina Partners
Encino, California, 91436, United States
Jacobs Retina center at the Shiley eye Institute UCSD
La Jolla, California, 92093, United States
South Coast Retina Center
Long Beach, California, 90807, United States
Southern CA Desert Retina Cons
Palm Desert, California, 92211, United States
California Eye Specialists Medical group Inc.
Pasadena, California, 91107, United States
Retina Consultants, San Diego
Poway, California, 92064, United States
Retina Consultants of Southern California
Redlands, California, 92373, United States
University of California, Davis, Eye Center
Sacramento, California, 95817, United States
Retina Consultants of Southern
Colorado Springs, Colorado, 80909, United States
Retina Group of New England
New London, Connecticut, 06320, United States
Rand Eye
Deerfield Beach, Florida, 33064, United States
Florida Eye Associates
Melbourne, Florida, 32901, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324, United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida, 33711, United States
Northwestern Medical Group/Northwestern University
Chicago, Illinois, 60611, United States
Retina Associates
Lenexa, Kansas, 66215, United States
Johns Hopkins Med
Baltimore, Maryland, 21287, United States
Retina Group of Washington
Chevy Chase, Maryland, 20815, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Associated Retinal Consultants
Grand Rapids, Michigan, 49546, United States
Midwest Vision Research Foundation
Chesterfield, Missouri, 63017, United States
Retina Associates of St. Louis
Florissant, Missouri, 63031, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
NJ Retina
Edison, New Jersey, 08820, United States
Retina Associates of NJ
Teaneck, New Jersey, 07666, United States
Long Is. Vitreoretinal Consult
Great Neck, New York, 11021, United States
Ophthalmic Cons of Long Island
Oceanside, New York, 11572, United States
Retina Assoc of Western NY
Rochester, New York, 14620, United States
The Retina Consultants
Slingerlands, New York, 12159, United States
Retina Vit Surgeons/Central NY
Syracuse, New York, 13224, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, 28803, United States
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, 28210, United States
Graystone Eye
Hickory, North Carolina, 28602, United States
Carolina Eye Associates
Southern Pines, North Carolina, 28387, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Retina Northwest
Portland, Oregon, 97221, United States
Mid Atlantic Retina - Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
Charleston Neuroscience Inst
Ladson, South Carolina, 29456, United States
Black Hills Eye Institute
Rapid City, South Dakota, 57701, United States
Charles Retina Institute
Germantown, Tennessee, 38138, United States
Tennessee Retina PC.
Nashville, Tennessee, 37203, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Retina & Vitreous of Texas
Houston, Texas, 77025, United States
Retina Consultants of Texas
Houston, Texas, 77030, United States
Valley Retina Institute P.A.
McAllen, Texas, 78503, United States
Rocky Mountain Retina
Salt Lake City, Utah, 84107, United States
Spokane Eye Clinical Research
Spokane, Washington, 99204, United States
Calgary Retina Consultants
Calgary, Alberta, T2J 0C8, Canada
University of British Columbia - Vancouver Coastal Health Authority
Vancouver, British Columbia, V5Z 1M9, Canada
Ivey Eye Institute
London, Ontario, N6A 4V2, Canada
University of Ottawa Eye Institute
Ottawa, Ontario, K1H 8L5, Canada
Retina Institute of Ottawa
Ottawa, Ontario, K2B 7E9, Canada
Toronto Retina Institute
Toronto, Ontario, M3C 0G9, Canada
Unity Health Toronto
Toronto, Ontario, M5C 2T2, Canada
Institut De L'Oeil Des Laurentides
Boisbriand, Quebec, J7H 1S6, Canada
Michel Giunta Clinique Medical
Sherbrooke, Quebec, J1G 2V4, Canada
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, 79106, Germany
Universitätsklinik Heidelberg
Heidelberg, 69120, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Budapest Retina Associates Kft.
Budapest, 1133, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Ganglion Medial Center
Pécs, 7621, Hungary
Zala Megyei Kórház
Zalaegerszeg, 8900, Hungary
Rambam Medical Center
Haifa, 3109601, Israel
Hadassah MC
Jerusalem, 91120, Israel
Rabin MC
Petah Tikva, 4941492, Israel
Kaplan Medical Center
Rehovot, 7660101, Israel
Tel Aviv Sourasky MC
Tel Aviv, 6423906, Israel
Ospedale Clinicizzato SS Annunziata
Chieti, Abruzzo, 66100, Italy
Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
Rome, Lazio, 00198, Italy
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena
Milan, Lombardy, 20100, Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia
Perugia, Umbria, 06129, Italy
Chukyo Hospital
Aichi, 457-8510, Japan
Nagoya University Hospital
Aichi, 466-8560, Japan
Nagoya City University Hospital
Aichi, 467-8602, Japan
Aichi Medical University Hospital
Aichi, 480-1195, Japan
Daiyukai Daiichi Hospital
Aichi, 491-8551, Japan
Chiba University Hospital
Chiba, 260-8677, Japan
Toho University Sakura Medical Center
Chiba, 285-8741, Japan
Hayashi Eye Hospital
Fukuoka, 812-0011, Japan
Kurume University Hospital
Fukuoka, 830-0011, Japan
Southern TOHOKU Eye Clinic
Fukushima, 963-8052, Japan
Sapporo City General Hospital
Hokkaido, 060-8604, Japan
Hokkaido University Hospital
Hokkaido, 060-8648, Japan
Asahikawa Medical University Hospital
Hokkaido, 078-8510, Japan
Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
Hyōgo, 660-8550, Japan
Hyogo Medical University Hospital
Hyōgo, 663-8501, Japan
Kozawa eye hospital and diabetes center
Ibaraki, 310-0845, Japan
Kagawa University Hospital
Kagawa, 761-0793, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Ideta Eye Hospital
Kumamoto, 860-0027, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Mie University Hospital
Mie, 514-8507, Japan
Fukushima Medical University Hospital
Miyagi, 960-1295, Japan
University of Miyazaki Hospital
Miyazaki, 889-1692, Japan
Shinshu University Hospital
Nagano, 390-8621, Japan
Iida Municipal Hospital
Nagano, 395-8502, Japan
Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, 852-8511, Japan
Nara Medical University Hospital
Nara, 634-8522, Japan
University of the Ryukyus Hospital
Okinawa, 903-0125, Japan
Kitano Hospital
Osaka, 530-8480, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
Kansai Medical University Medical Center
Osaka, 570-8507, Japan
Kansai Medical University Hospital
Osaka, 573-1191, Japan
National Defense Medical College Hospital
Saitama, 359-8513, Japan
Shiga University Of Medical Science Hospital
Shiga, 520-2192, Japan
Tokushima University Hospital
Tokushima, 770-8503, Japan
Nihon University Hospital
Tokyo, 101-8309, Japan
Takeuchi eye clinic
Tokyo, 111-0051, Japan
Tokyo Women's Medical University Hospital
Tokyo, 162-8666, Japan
Kyorin University Hospital
Tokyo, 181-8611, Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, 193-0998, Japan
Yamaguchi University Hospital
Yamaguchi, 755-8505, Japan
Centro Oftalmológico Mira, S.C
Cuauhtémoc, Mexico CITY (federal District), 06760, Mexico
Macula Retina Consultores
México, Mexico CITY (federal District), 01120, Mexico
Montemayor & Asociados (Oftalmologos)
Monterrey, Nuevo León, 64060, Mexico
Het Oogziekenhuis Rotterdam
Rotterdam, 3011 BH, Netherlands
ETZ Elisabeth
Tilburg, 5022 GC, Netherlands
Szpital sw. Lukasza
Bielsko-Biala, 43-309, Poland
Specjalistyczny O?rodek Okulistyczny Oculomedica
Bydgoszcz, 85-870, Poland
Szpital Specjalistyczny nr 1
Bytom, 41-902, Poland
Dobry Wzrok Sp Z O O
Gdansk, 80-822, Poland
Gabinet Okulistyczny Prof Edward Wylegala
Katowice, 40-594, Poland
Centrum Medyczne Dietla 19 Sp. Z O.O.
Krakow, 31-070, Poland
SPEKTRUM Osrodek Okulistyki Klinicznej
Wroclaw, 53-334, Poland
FSBI ?Scientific Research Institute of Eye Diseases? of Russian Academy of medical Sciences
Moscow, Moscow Oblast, 119435, Russia
Medical Military Academy n.a S.M.Kirov
Saint Petersburg, Sankt-Peterburg, 124044, Russia
Clinics of Eye Diseases, LLC
Kazan', Tatarstan Republic, 420066, Russia
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, 08195, Spain
Instituto Oftalmologico Gomez Ulla
Santiago de Compostela, LA Coruna, 15706, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
Oftalvist Valencia
Burjassot, Valencia, 46100, Spain
Hospital dos de maig
Barcelona, 08025, Spain
Clinica Universitaria de Navarra
Madrid, 28027, Spain
Clinica Baviera
Madrid, 28046, Spain
Vista Klinik Ophthalmologische Klinik
Binningen, 4102, Switzerland
Stadtspital Triemli Ophthalmologische Klinik
Zurich, 8063, Switzerland
Ankara Baskent University Medical Faculty; Department of Ophthalmology
Ankara, 06490, Turkey (Türkiye)
Kocaeli Üniversitesi Tıp Fakültesi; Department of Ophthalmology
Kocaeli, 41380, Turkey (Türkiye)
Selcuk University Faculty of Medicine; Department Of Ophthalmology
Konya, 42130, Turkey (Türkiye)
Bradford Royal Infirmary
Bradford, BD9 6RJ, United Kingdom
Bristol Eye Hospital
Bristol, BS1 2LX, United Kingdom
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
Frimley Park Hospital
Frimley, GU16 7UJ, United Kingdom
Gloucestershire Royal Hospital
Gloucester, GL1 3NN, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
Royal Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD, United Kingdom
Royal Free Hospital
London, NW3 2QS, United Kingdom
Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
The York Hospital
York, YO31 8HE, United Kingdom
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: 38382813RESULTTakahashi 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: 37294433DERIVEDKhanani 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: 36246941DERIVEDHeier 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: 35085502DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
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
February 19, 2019
Primary Completion
October 26, 2020
Study Completion
January 18, 2022
Last Updated
July 23, 2025
Results First Posted
May 4, 2022
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing