A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
AVONELLE-X
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (AVONELLE-X)
2 other identifiers
interventional
1,036
26 countries
249
Brief Summary
This main long-term extension study is designed to evaluate the long-term safety and tolerability of faricimab 6 milligrams (mg) administered by intravitreal injection at a personalized treatment interval (PTI) to participants with neovascular age-related macular degeneration (nAMD) who enrolled in and completed one of the Phase III studies: GR40306 (NCT03823287) or GR40844 (NCT03823300), also referred to as the parent studies. Eligible patients who consent to participate in this main study will be enrolled upon completion of the end-of-study visit in the parent study. Additionally, there is a substudy that is being conducted. The aim of this substudy is to evaluate the impact of intravitreal faricimab on the health of the corneal endothelial cells in the study eyes of patients with nAMD to fulfill a U.S. Food and Drug Administration (FDA) post-marketing requirement. The fellow eyes of the same enrolled participants in the substudy will serve as the controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2021
Typical duration for phase_3
249 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
February 26, 2021
CompletedFirst Posted
Study publicly available on registry
March 2, 2021
CompletedStudy Start
First participant enrolled
April 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2024
CompletedResults Posted
Study results publicly available
October 24, 2025
CompletedOctober 24, 2025
October 1, 2025
3.4 years
February 26, 2021
September 2, 2025
October 9, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
This is an analysis of participants with at least one ocular adverse event (AE) that occurred in the study eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity (e.g., mild, moderate, or severe intensity), and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.
From the date of first administration of faricimab through 28 days after the end of study (up to 2 years)
Incidence of Ocular Adverse Events in the Fellow Eye
This is an analysis of participants with at least one ocular adverse event (AE) that occurred in the study eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity, and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.
From the date of first administration of faricimab through 28 days after the end of study (up to 2 years)
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale
This is an analysis of participants with at least one non-ocular (systemic) adverse event (AE). Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity (e.g., mild, moderate, or severe intensity), and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.
From the date of first administration of faricimab through 28 days after the end of study (up to 2 years)
Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at 1 Year in the Study Eye as Compared With the Fellow Eye
Specular microscopy was performed for both eyes prior to application of any topical ophthalmic anesthetic, tonometry, or any other study treatment on the same day for the evaluation of corneal endothelial cell (CEC) density. The 1-year timepoint was defined as the earliest substudy visit closest to Week 52 occurring between Week 48 and Week 64. Data (from both study eye and fellow eye) collected after the fellow eye's use of prohibited therapies-such as faricimab, brolucizumab, bevacizumab, and Port Delivery System implantation-were excluded from the corneal endothelial cell analysis.
Baseline and 1 year
Secondary Outcomes (1)
Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye
Baseline and Week 24
Study Arms (2)
Main Study: Faricimab PTI
EXPERIMENTALSubstudy: Faricimab PTI
EXPERIMENTALInterventions
Faricimab 6 mg will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.
The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. The sham procedure will be administered to participants as appropriate during the first 12 weeks of this study in order to maintain the masking of the initial faricimab PTI.
At the discretion of the principal investigator, participants were allowed to have their fellow (non-study) eye treated with the standard of care anti-VEGF therapy (if needed) according to region-specific anti-VEGF prescribing information for the recommended dose and frequency of treatment.
Eligibility Criteria
You may qualify if:
- Previous enrollment in and completion of Study GR40306 (NCT03823287) or Study GR40844 (NCT03823300), without study or study drug discontinuation
- For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs. Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 3 months after the final dose of faricimab. Women must refrain from donating eggs during the same period.
- Sign an informed consent form for the Substudy
- Must be able to participate for at least 48 weeks in the Substudy and have at least the first visit while enrolled in the main Study GR42691
- A difference of \<10% in corneal endothelial cell density at screening between the two eyes as measured by specular microscopy and determined by the independent reading center
You may not qualify if:
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab
- Presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
- Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
- History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections, study-related procedure preparations, dilating drops, or any of the anesthetic and antimicrobial preparations used by a patient during the study
- Requirement for continuous use of any medications or treatments indicated as prohibited therapy
- Prior and/or current administration of faricimab in the fellow (non-study) eye
- Prior administration of brolucizumab in the fellow (non-study) eye
- Corneal endothelial cell density ≤1500 cells/mm2 in either eye at screening as determined by the independent corneal reading center
- Fuchs endothelial corneal dystrophy Grade ≥2
- Previous ocular trauma (blunt or penetrating) and/or corneal endothelial cell damage, including from blunt or surgical trauma (including complicated cataract surgery resulting in complicated lens placement such as anterior chamber intraocular lens, sulcus intraocular lens, aphakia, etc.)
- Any ocular condition that precludes obtaining an analyzable specular microscopy image
- Active or history of corneal edema
- Any active or history of corneal dystrophies, excluding Fuchs endothelial corneal dystrophy Grade \<2
- Active or history of iridocorneal endothelial syndrome
- Active or history of pseudoexfoliation syndrome
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (251)
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, 85206, United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, 85016, United States
Associated Retina Consultants
Phoenix, Arizona, 85020, 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
South Coast Retina Center
Los Angeles, California, 90033, United States
Northern California Retina Vitreous Associates
Mountain View, California, 94040, 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
Retinal Consultants Med Group
Sacramento, California, 95825, United States
Orange County Retina Med Group
Santa Ana, California, 92705, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Retina Consultants of Southern
Colorado Springs, Colorado, 80909, United States
Colorado Retina Associates, PC
Lakewood, Colorado, 80228, United States
Retina Group of New England
Waterford, Connecticut, 06385, United States
Rand Eye
Deerfield Beach, Florida, 33064, United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308, United States
Florida Eye Associates
Melbourne, Florida, 32901, United States
Retina Care Specialists
Palm Beach Gardens, Florida, 33410, 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
Southern Vitreoretinal Assoc
Tallahassee, Florida, 32308, United States
Retina Associates of Florida, LLC
Tampa, Florida, 33609, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Georgia Retina PC
Marietta, Georgia, 30060, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701, United States
Northwestern Medical Group/Northwestern University
Chicago, Illinois, 60611, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, 60452, United States
Prairie Retina Center
Springfield, Illinois, 62704, United States
Raj K. Maturi, MD PC
Indianapolis, Indiana, 46290, United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266, United States
Retina Associates
Lenexa, Kansas, 66215, United States
Maine Eye Center
Portland, Maine, 04101, United States
Retina Specialists
Baltimore, Maryland, 21204, United States
The Retina Care Center
Baltimore, Maryland, 21209, 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
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
VitreoRetinal Surgery, PLLC.
Edina, Minnesota, 55435, 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
Mid Atlantic Retina - Wills Eye Hospital
Cherry Hill, New Jersey, 08034, 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
Vitreoretinal Consultants of New York
Shirley, New York, 11967, 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
Winston-Salem, North Carolina, 27104, United States
Cincinnati Eye Institute
Blue Ash, Ohio, 45242-5537, United States
Retina Assoc of Cleveland Inc
Cleveland, Ohio, 44122, United States
The Ohio State University Havener Eye Institute
Columbus, Ohio, 43212, United States
Midwest Retina
Dublin, Ohio, 43016, United States
Retina Northwest
Portland, Oregon, 97221, United States
Charleston Neuroscience Inst
Ladson, South Carolina, 29456, United States
Palmetto Retina Center
West Columbia, South Carolina, 29169, United States
Black Hills Eye Institute
Rapid City, South Dakota, 57701, United States
Southeastern Retina Associates Chattanooga
Chattanooga, Tennessee, 37421, United States
Charles Retina Institute
Germantown, Tennessee, 38138, United States
Tennessee Retina PC.
Nashville, Tennessee, 37203, United States
Retina Res Institute of Texas
Abilene, Texas, 79606, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Austin Clinical Research LLC
Austin, Texas, 78750, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Retina Consultants of Texas
Houston, Texas, 77030, United States
Valley Retina Institute P.A.
McAllen, Texas, 78503, United States
Retina Center of Texas
Southlake, Texas, 76092, United States
Retina Consultants of Houston
The Woodlands, Texas, 77384, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087, United States
Retina Associates of Utah, PLLC
Salt Lake City, Utah, 84107, United States
Rocky Mountain Retina
Salt Lake City, Utah, 84107, United States
Piedmont Eye Center
Lynchburg, Virginia, 24502, United States
Wagner Kapoor Institute
Norfolk, Virginia, 23451, United States
Pacific Northwest Retina
Silverdale, Washington, 98383, United States
Organizacion Medica de Investigacion
Buenos Aires, C1015ABO, Argentina
Fundacion Zambrano
CABA, 1023, Argentina
Centro Oftalmologico Dr. Charles S.A.
Capital Federal, C1116, Argentina
Oftalmos
Capital Federal, C1120AAN, Argentina
Buenos Aires Mácula
Ciudad Autonoma Buenos Aires, C1061AAE, Argentina
Oftar
Mendoza, M5500GGK, Argentina
Grupo Laser Vision
Rosario, S2000DLA, Argentina
Eyeclinic Albury Wodonga
Albury, New South Wales, 2640, Australia
Sydney Eye Hospital
Sydney, New South Wales, 2000, Australia
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, 2000, Australia
Sydney West Retina
Westmead, New South Wales, 2145, Australia
Centre For Eye Research Australia
East Melbourne, Victoria, 3002, Australia
Retina Specialists Victoria
Rowville, Victoria, 3178, Australia
The Lions Eye Institute
Nedlands, Western Australia, 6009, Australia
LKH-Univ.Klinikum Graz
Graz, 8036, Austria
Medizinische Universitat Wien
Vienna, 1090, Austria
Hospital de Olhos de Aparecida - HOA
Aparecida de Goiânia, Goiás, 74980-010, Brazil
Universidade Federal de Sao Paulo - UNIFESPX
São Paulo, São Paulo, 04023-062, Brazil
Pentagram Eye Hospital (Medical Center "Pentagram")
Sofia, 1309, Bulgaria
Specialized Hospital for Active Treatment of Eye Diseases Zora
Sofia, 1784, Bulgaria
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
Retina Institute of Ottawa
Ottawa, Ontario, K2B 7E9, Canada
Toronto Retina Institute
Toronto, Ontario, M3C 0G9, Canada
Institut De L'Oeil Des Laurentides
Boisbriand, Quebec, J7H 0E8, Canada
Michel Giunta Clinique Medical
Sherbrooke, Quebec, J1G 2V4, Canada
Rigshospitalet Glostrup
Glostrup Municipality, 2600, Denmark
Sjællands Universitetshospital, Roskilde
Roskilde, 4000, Denmark
Chi De Creteil
Créteil, 94010, France
Pole Vision Val d'Ouest
Écully, 69130, France
Hopital de la croix rousse
Lyon, 69317, France
Centre Paradis Monticelli
Marseille, 13008, France
CHU Nantes - Hotel Dieu
Nantes, 44093, France
Hopital Lariboisiere
Paris, 75010, France
Universitatsklinikum Koln
Cologne, 50937, Germany
Universitätkslinikum Düsseldorf, Augenklinik
Düsseldorf, 40225, Germany
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, 79106, Germany
Universitätsklinik Heidelberg
Heidelberg, 69120, Germany
Augenabteilung am St. Franziskus-Hospital
Münster, 48145, Germany
Universitatsklinikum Munster
Münster, 48149, Germany
The University of Hong Kong
Hong Kong, Hong Kong
Hong Kong Eye Hospital
Mong Kok, Hong Kong
Eszak-Pesti Centrumkorhaz - Honvedkorhaz
Budapest, 1068, Hungary
Bajcsy-Zsilinszky Hospital
Budapest, 1106, Hungary
Budapest Retina Associates Kft.
Budapest, 1133, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecem, 4032, Hungary
Ganglion Medial Center
Pécs, 7621, Hungary
Szegedi Tudományegyetem ÁOK
Szeged, 6720, Hungary
Zala Megyei Kórház
Zalaegerszeg, 8900, Hungary
Rambam Medical Center
Haifa, 3109601, Israel
Hadassah MC
Jerusalem, 9112001, Israel
Rabin MC
Petah Tikva, 4941492, Israel
Kaplan Medical Center
Rehovot, 7660101, Israel
Tel Aviv Sourasky MC
Tel Aviv, 6423906, Israel
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
Asst Fatebenefratelli Sacco
Milan, Lombardy, 20157, Italy
Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello
Pisa, Tuscany, 56124, Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia
Perugia, Umbria, 06129, Italy
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
Sapporo City General Hospital
Hokkaido, 060-8604, 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
Nihon University Hospital
Tokyo, 101-8309, 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
Del. Cuauhtemoc, Mexico CITY (federal District), 06760, Mexico
Macula Retina Consultores
Mexico City, Mexico CITY (federal District), 01120, Mexico
Montemayor & Asociados (Oftalmologos)
Monterrey Nuevo LEON, Nuevo León, 64060, Mexico
Het Oogziekenhuis Rotterdam
Rotterdam, 3011 BH, Netherlands
Szpital sw. Lukasza
Bielsko-Biala, 43-309, Poland
OFTALMIKA Sp. z o.o
Bydgoszcz, 85-631, Poland
Specjalistyczny O?rodek Okulistyczny Oculomedica
Bydgoszcz, 85-870, Poland
Szpital Specjalistyczny nr 1
Bytom, 41-902, Poland
Dobry Wzrok Sp Z O O
Gda?sk, 80-402, Poland
Optimum Profesorskie Centrum Okulistyki
Gda?sk, 80-809, Poland
Gabinet Okulistyczny Prof Edward Wylegala
Katowice, 40-594, Poland
Centrum Medyczne Dietla 19 Sp. Z O.O.
Krakow, 31-070, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
Krakow, 31-501, Poland
Caminomed
Tarnowskie Góry, 42-600, Poland
SPEKTRUM Osrodek Okulistyki Klinicznej
Wroclaw, 53-334, Poland
Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia
Coimbra, 3000-075, Portugal
Hospital de Sao Joao
Porto, 4200-319, Portugal
Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov
Cheboksary, Mariy-El Republic, 428000, Russia
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
1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov
Saint Petersburg, Sankt-Peterburg, 197022, Russia
Clinics of Eye Diseases, LLC
Kazan', Tatarstan Republic, 420066, Russia
?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch
Novosibirsk, 630096, Russia
Singapore Eye Research Institute
Singapore, 168751, Singapore
Pusan National University Hospital
Busan, 49241, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13605, South Korea
Samsung Medical Center
Seoul, (0)6351, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Nune Eye Hospital
Seoul, 06192, South Korea
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital General de Catalunya
San Cugat Del Valles, 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
Instituto Oftalmologico Fernandez Vega
Oviedo, Principality of Asturias, 33012, Spain
Oftalvist Valencia
Burjassot, Valencia, 46100, Spain
Institut de la Macula i la retina
Barcelona, 08022, Spain
Hospital dos de maig
Barcelona, 08025, Spain
Hospital Clinic de Barcelona
Barcelona, 08028, Spain
Clinica Baviera
Madrid, 28046, Spain
Hospital Universitario Rio Hortega
Valladolid, 47012, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Vista Klinik Ophthalmologische Klinik
Binningen, 4102, Switzerland
Changhua Christian Hospital
Changhua, 500, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, 333, Taiwan
Hacettepe University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, 06340, Turkey (Türkiye)
Ankara Baskent University Medical Faculty
Ankara, 06490, Turkey (Türkiye)
Gazi University Faculty of Medicine
Ankara, 06560, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, 35100, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, 41380, Turkey (Türkiye)
Selcuk University Faculty of Medicine
Konya, 42130, Turkey (Türkiye)
Opthalmology Research Office
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 Hospitals NHS Foundation Trust
Gloucestershire, 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
Manchester Royal Eye Hospital
Manchester, M13 9WL, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
The York Hospital
York, YO31 8HE, United Kingdom
MeSH Terms
Interventions
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
- NA
- Masking
- NONE
- Masking Details
- The first 12 weeks of the main study will be a masked period (to transition from the multi-arm parent studies) during which participants may receive either faricimab or sham injection. Participants and physicians will be masked only to the faricimab treatment interval. After the Week 12 treatment procedure, this study will follow an open-label design. The BCVA examiner will remain masked for the duration of the main long-term extension study.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2021
First Posted
March 2, 2021
Study Start
April 19, 2021
Primary Completion
September 3, 2024
Study Completion
September 3, 2024
Last Updated
October 24, 2025
Results First Posted
October 24, 2025
Record last verified: 2025-10
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