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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Drug: Faricimab; Other: Sham Procedure

• Study Type: Interventional
• Enrollment (Actual): 1036
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1017AAO
    • Fundacion Zambrano
  • Capital Federal, Argentina, C1015ABO
    • Centro Oftalmológico Dr. Charles S.A.
  • Capital Federal, Argentina, C1120AAN
    • Oftalmos
  • Ciudad Autonoma Buenos Aires, Argentina, C1061AAE
    • Buenos Aires Mácula
  • Mendoza, Argentina, M5500GGK
    • Oftar
  • Rosario, Argentina, S2000DLA
    • Grupo Laser Vision
  • San Nicolás, Argentina, C1015ABO
    • Organizacion Medica de Investigacion
• Australia
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Eyeclinic Albury Wodonga
    • Strathfield, New South Wales, Australia, 2135
      • Strathfield Retina Clinic
    • Sydney, New South Wales, Australia, 2000
      • Sydney Eye Hospital
    • Sydney, New South Wales, Australia, 2000
      • Sydney Retina Clinic and Day Surgery
    • Westmead, New South Wales, Australia, 2145
      • Sydney West Retina
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Centre For Eye Research Australia
    • Rowville, Victoria, Australia, 3178
      • Retina Specialists Victoria
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • The Lions Eye Institute
• Austria
  • Graz, Austria, 8036
    • LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
  • Wien, Austria, 1090
    • Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
• Brazil
  • GO
    • Aparecida de Goiania, GO, Brazil, 74980-010
      • Hospital de Olhos de Aparecida - HOA
  • SP
    • Sao Paulo, SP, Brazil, 04023-062
      • Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
• Bulgaria
  • Sofia, Bulgaria, 1309
    • Pentagram Eye Hospital (Medical Center "Pentagram")
  • Sofia, Bulgaria, 1784
    • Specialized Hospital For Active Treatment of Eye Diseases Zora
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 0C8
      • Calgary Retina Consultants
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • University of British Columbia - Vancouver Coastal Health Authority
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • Ivey Eye Institute
    • Ottawa, Ontario, Canada, K2B 7E9
      • The Retina Centre of Ottawa
    • Toronto, Ontario, Canada, M3C 0G9
      • Toronto Retina Institute
  • Quebec
    • Boisbriand, Quebec, Canada, J7H 0E8
      • Institut De L'Oeil Des Laurentides
    • Sherbrooke, Quebec, Canada, J1G 2V4
      • Michel Giunta Clinique Medical
• Denmark
  • Glostrup, Denmark, 2600
    • Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning
  • Roskilde, Denmark, 4000
    • Sjællands Universitetshospital, Roskilde; Øjenafdelingen
• France
  • Creteil, France, 94010
    • Chi De Creteil; Ophtalmologie
  • Ecully, France, 69130
    • Pole Vision Val d'Ouest; Ophtalmologie
  • Lyon cedex, France, 69317
    • Hopital de la croix rousse; Ophtalmologie
  • Marseille, France, 13008
    • Centre Paradis Monticelli; Ophtalmologie
  • Nantes, France, 44093
    • CHU Nantes - Hôtel Dieu; Ophthalmology
  • Paris, France, 75010
    • Hopital Lariboisiere; Ophtalmologie
• Germany
  • Düsseldorf, Germany, 40225
    • Universitätkslinikum Düsseldorf, Augenklinik; Klinik fürAugenheilkunde
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg, Klinik für Augenheilkunde
  • Heidelberg, Germany, 69120
    • Universitätsklinik Heidelberg; Augenklinik
  • Köln, Germany, 50937
    • Universitätsklinikum Köln; Augenklinik
  • Münster, Germany, 48145
    • Augenabteilung am St. Franziskus-Hospital
  • Münster, Germany, 48149
    • Universitätsklinikum Münster; Augenheilkunde
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital; Department of Ophthalmology
  • Mongkok, Hong Kong
    • Hong Kong Eye Hospital; CUHK Eye Centre
• Hungary
  • Budapest, Hungary, 1133
    • Budapest Retina Associates Kft.
  • Budapest, Hungary, 1106
    • Bajcsy-Zsilinszky Hospital
  • Budapest, Hungary, 1068
    • Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Szemeszet
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
  • Pécs, Hungary, 7621
    • Ganglion Medial Center
  • Szeged, Hungary, 6720
    • Szegedi Tudományegyetem ÁOK; Department of Ophtalmology
  • Zalaegerszeg, Hungary, 8900
    • Zala Megyei Kórház; SZEMESZET
• Israel
  • Haifa, Israel, 3109601
    • Rambam Medical Center; Opthalmology
  • Jerusalem, Israel, 9112001
    • Hadassah MC; Ophtalmology
  • Petach Tikva, Israel, 4941492
    • Rabin MC; Ophtalmology
  • Rehovot, Israel, 7660101
    • Kaplan Medical Center; Ophtalmology
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky MC; Ophtalmology
• Italy
  • Lazio
    • Roma, Lazio, Italy, 00198
      • Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
  • Lombardia
    • Milano, Lombardia, Italy, 20100
      • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
    • Milano, Lombardia, Italy, 20157
      • ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
  • Toscana
    • Pisa, Toscana, Italy, 56124
      • Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria
  • Umbria
    • Perugia, Umbria, Italy, 06129
      • Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica
• Japan
  • Aichi, Japan, 480-1195
    • Aichi Medical University Hospital
  • Aichi, Japan, 466-8560
    • Nagoya University Hospital
  • Aichi, Japan, 467-8602
    • Nagoya City University Hospital
  • Aichi, Japan, 491-8551
    • Daiyukai Daiichi Hospital
  • Chiba, Japan, 260-8677
    • Chiba University Hospital
  • Chiba, Japan, 285-8741
    • Toho University Sakura Medical Center
  • Fukuoka, Japan, 830-0011
    • Kurume University Hospital
  • Fukuoka, Japan, 812-0011
    • Hayashi Eye Hospital
  • Fukushima, Japan, 960-1295
    • Fukushima Medical University Hospital
  • Hokkaido, Japan, 060-8604
    • Sapporo City General Hospital
  • Hokkaido, Japan, 078-8510
    • Asahikawa Medical University Hospital
  • Hyogo, Japan, 663-8501
    • Hyogo Medical University Hospital
  • Hyogo, Japan, 660-8550
    • Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
  • Ibaraki, Japan, 310-0845
    • Kozawa eye hospital and diabetes center
  • Kagawa, Japan, 761-0793
    • Kagawa University Hospital
  • Kagoshima, Japan, 890-8520
    • Kagoshima University Hospital
  • Kumamoto, Japan, 860-0027
    • Ideta Eye Hospital
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Mie, Japan, 514-8507
    • Mie University Hospital
  • Miyazaki, Japan, 889-1692
    • University of Miyazaki Hospital
  • Nagano, Japan, 390-8621
    • Shinshu University Hospital
  • Nagano, Japan, 395-8502
    • Iida Municipal Hospital
  • Nagasaki, Japan, 852-8511
    • Japanese Red Cross Nagasaki Genbaku Hospital
  • Nara, Japan, 634-8522
    • Nara Medical University Hospital
  • Okinawa, Japan, 903-0125
    • University of the Ryukyus Hospital
  • Osaka, Japan, 545-8586
    • Osaka Metropolitan University Hospital
  • Osaka, Japan, 530-8480
    • Kitano Hospital
  • Osaka, Japan, 570-8507
    • Kansai Medical University Medical Center
  • Osaka, Japan, 573-1191
    • Kansai Medical University Hospital
  • Saitama, Japan, 359-8513
    • National Defense Medical College Hospital
  • Shiga, Japan, 520-2192
    • Shiga University Of Medical Science Hospital
  • Tokyo, Japan, 162-8666
    • Tokyo Women's Medical University Hospital
  • Tokyo, Japan, 101-8309
    • Nihon University Hospital
  • Tokyo, Japan, 193-0998
    • Tokyo Medical University Hachioji Medical Center
  • Tokyo, Japan, 181-8611
    • Kyorin University Hospital
  • Yamaguchi, Japan, 755-8505
    • Yamaguchi University Hospital
• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Pusan National University Hospital
  • Daegu, Korea, Republic of, 42415
    • Yeungnam University Medical Center
  • Seongnam-si, Korea, Republic of, 463-707
    • Seoul national university bundang hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02447
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06192
    • Nune Eye Hospital; Ophthalmology
• Mexico
  • Mexico CITY (federal District)
    • Del. Cuauhtemoc, Mexico CITY (federal District), Mexico, 06760
      • Centro Oftalmológico Mira, S.C
    • Mexico, D.F., Mexico CITY (federal District), Mexico, 01120
      • Macula Retina Consultores
  • Nuevo LEON
    • Monterrey Nuevo LEON, Nuevo LEON, Mexico, 64060
      • Montemayor & Asociados (Oftalmologos)
• Netherlands
  • Rotterdam, Netherlands, 3011 BH
    • Het Oogziekenhuis Rotterdam
• Poland
  • Bielsko-Biala, Poland, 43-309
    • Szpital sw. Lukasza
  • Bydgoszcz, Poland, 85-631
    • OFTALMIKA Sp. z o.o
  • Bydgoszcz, Poland, 85-870
    • Specjalistyczny O?rodek Okulistyczny Oculomedica
  • Bytom, Poland, 41-902
    • Szpital Specjalistyczny nr 1; Oddzial Okulistyki
  • Gda?sk, Poland, 80-402
    • Dobry Wzrok Sp Z O O
  • Gda?sk, Poland, 80-809
    • Optimum Profesorskie Centrum Okulistyki
  • Katowice, Poland, 40-594
    • Gabinet Okulistyczny Prof Edward Wylegala
  • Krakow, Poland, 31-501
    • SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
  • Kraków, Poland, 31-070
    • Centrum Medyczne Dietla 19 Sp. z o.o.
  • Tarnowskie Góry, Poland, 42-600
    • Caminomed
  • Wroclaw, Poland, 53-334
    • SPEKTRUM Osrodek Okulistyki Klinicznej
• Portugal
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia
  • Porto, Portugal, 4200-319
    • Hospital de Sao Joao; Servico de Oftalmologia
• Russian Federation
  • Novosibirsk, Russian Federation, 630096
    • ?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch
  • Marij EL
    • Cheboksary, Marij EL, Russian Federation, 428000
      • Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch
  • Moskovskaja Oblast
    • Moscow, Moskovskaja Oblast, Russian Federation, 119435
      • FSBI ?Scientific Research Institute of Eye Diseases? of Russian Academy of medical Sciences
  • Sankt Petersburg
    • Sankt-peterburg, Sankt Petersburg, Russian Federation, 197022
      • 1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology
    • St.Petersburg, Sankt Petersburg, Russian Federation, 124044
      • Medical Military Academy n.a S.M.Kirov
  • Tatarstan
    • Kazan, Tatarstan, Russian Federation, 420066
      • Clinics of Eye Diseases, LLC
• Singapore
  • Singapore, Singapore, 168751
    • Singapore Eye Research Institute
• Spain
  • Barcelona, Spain, 08022
    • Institut de la Macula i la retina
  • Barcelona, Spain, 08025
    • Hospital dos de maig; servicio de oftalmologia
  • Barcelona, Spain, 08028
    • Hospital Clinic de Barcelona; Consultas Externas Oftalmologia
  • Madrid, Spain, 28046
    • Clinica Baviera; Servicio Oftalmologia
  • Valladolid, Spain, 47012
    • Hospital Universitario Rio Hortega; Servicio de Oftalmologia
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet; Servicio de Oftalmologia
  • Asturias
    • Oviedo, Asturias, Spain, 33012
      • Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitario de Bellvitge
    • San Cugat Del Valles, Barcelona, Spain, 08195
      • Hospital General de Catalunya
  • LA Coruña
    • Santiago de Compostela, LA Coruña, Spain, 15706
      • Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra; Servicio de Oftalmologia
  • Valencia
    • Burjassot, Valencia, Spain, 46100
      • Oftalvist Valencia
• Switzerland
  • Binningen, Switzerland, 4102
    • Vista Klinik Ophthalmologische Klinik
• Taiwan
  • Changhua, Taiwan, 500
    • Changhua Christian Hospital; Department of Ophthalmology
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital; Ophthalmology
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation - Linkou; Ophthalmology
• Turkey
  • Ankara, Turkey, 06340
    • Ankara University Medical Faculty; Department of Ophthalmology
  • Ankara, Turkey, 06490
    • Ankara Baskent University Medical Faculty; Department of Ophthalmology
  • Ankara, Turkey, 06100
    • Hacettepe University Medical Faculty; Department of Ophthalmology
  • Ankara, Turkey, 06560
    • Gazi University Faculty of Medicine; Department Of Ophthalmology
  • Izmir, Turkey, 35100
    • Ege University Medical Faculty; Department of Ophthalmology
  • Kocaeli, Turkey, 41380
    • Kocaeli University Medical Faculty
  • Konya, Turkey, 42130
    • Selcuk University Faculty of Medicine; Department Of Ophthalmology
• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • Opthalmology Research Office
  • Bristol, United Kingdom, BS1 2LX
    • Bristol Eye Hospital;Retinal Treatment and Research Unit
  • Cardiff, United Kingdom, CF14 4XW
    • University Hospital of Wales
  • Frimley, United Kingdom, GU16 7UJ
    • Frimley Park Hospital
  • Gloucestershire, United Kingdom, GL1 3NN
    • Gloucestershire Hospitals NHS Foundation Trust
  • Hull, United Kingdom, HU3 2JZ
    • Hull Royal Infirmary
  • Leeds, United Kingdom, LS9 7TF
    • St James University Hospital
  • Liverpool, United Kingdom, L7 8YE
    • Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
  • London, United Kingdom, EC1V 2PD
    • Moorfields Eye Hospital NHS Foundation Trust
  • Manchester, United Kingdom, M13 9WL
    • Manchester Royal Eye Hospital
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary
  • Southampton, United Kingdom, SO16 6YD
    • University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit
  • Wolverhampton, United Kingdom, WV10 0QP
    • New Cross Hospital
  • York, United Kingdom, YO31 8HE
    • The York Hospital
• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Barnet Dulaney Perkins Eye Center
    • Phoenix, Arizona, United States, 85020
      • Associated Retina Consultants
    • Phoenix, Arizona, United States, 85016
      • Arizona Retina and Vitreous Consultants
    • Tucson, Arizona, United States, 85704
      • Retina Associates Southwest PC
  • California
    • Campbell, California, United States, 95008
      • Retinal Diagnostic Center
    • Encino, California, United States, 91436
      • The Retina Partners
    • Los Angeles, California, United States, 90033
      • South Coast Retina Center
    • Mountain View, California, United States, 94040
      • Northern California Retina Vitreous Associates
    • Palm Desert, California, United States, 92211
      • Southern CA Desert Retina Cons
    • Pasadena, California, United States, 91107
      • California Eye Specialists Medical group Inc.
    • Poway, California, United States, 92064
      • Retina Consultants, San Diego
    • Redlands, California, United States, 92373
      • Retina Consultants of Southern California
    • Sacramento, California, United States, 95825
      • Retinal Consultants Med Group
    • Sacramento, California, United States, 95817
      • University of California, Davis, Eye Center
    • Santa Ana, California, United States, 92705
      • Orange County Retina Med Group
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Retina Consultants of Southern
    • Lakewood, Colorado, United States, 80228
      • Colorado Retina Associates, PC
  • Connecticut
    • Waterford, Connecticut, United States, 06385
      • Retina Group of New England
  • Florida
    • Deerfield Beach, Florida, United States, 33064
      • Rand Eye
    • Fort Lauderdale, Florida, United States, 33308
      • Retina Group of Florida
    • Melbourne, Florida, United States, 32901
      • Florida Eye Associates
    • Palm Beach Gardens, Florida, United States, 33410
      • Retina Care Specialists
    • Pensacola, Florida, United States, 32503
      • Retina Specialty Institute
    • Plantation, Florida, United States, 33324
      • Fort Lauderdale Eye Institute
    • Saint Petersburg, Florida, United States, 33711
      • Retina Vitreous Assoc of FL
    • Tallahassee, Florida, United States, 32308
      • Southern Vitreoretinal Assoc
    • Tampa, Florida, United States, 33609
      • Retina Associates of Florida, LLC
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Southeast Retina Center
    • Marietta, Georgia, United States, 30060-1137
      • Georgia Retina PC
  • Hawaii
    • 'Aiea, Hawaii, United States, 96701
      • Retina Consultants of Hawaii
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Group/Northwestern University
    • Oak Forest, Illinois, United States, 60452
      • University Retina and Macula Associates, PC
    • Springfield, Illinois, United States, 62704
      • Prairie Retina Center
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Raj K. Maturi, MD PC
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Wolfe Eye Clinic
  • Kansas
    • Lenexa, Kansas, United States, 66215
      • Retina Associates
  • Maine
    • Portland, Maine, United States, 04101
      • Maine Eye Center
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • The Retina Care Center
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Med; Wilmer Eye Inst
    • Chevy Chase, Maryland, United States, 20815
      • Retina Group of Washington
    • Hagerstown, Maryland, United States, 21740
      • Cumberland Valley Retina PC
    • Towson, Maryland, United States, 21204
      • Retina Specialists
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center; Ophthalmology
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Associated Retinal Consultants
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Midwest Vision Research Foundation
    • Florissant, Missouri, United States, 63031
      • Retina Associates of St. Louis
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • New Jersey
    • Edison, New Jersey, United States, 08820
      • NJ Retina
    • Teaneck, New Jersey, United States, 07666
      • Retina Associates of NJ
  • New York
    • Hauppauge, New York, United States, 11788
      • Long Is. Vitreoretinal Consult
    • Liverpool, New York, United States, 13088
      • Retina Vit Surgeons/Central NY
    • Oceanside, New York, United States, 11572
      • Ophthalmic Cons of Long Island
    • Rochester, New York, United States, 14620
      • Retina Assoc of Western NY
    • Shirley, New York, United States, 11967
      • Island Retina
    • Slingerlands, New York, United States, 12159
      • The Retina Consultants
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Western Carolina Retinal Associate PA
    • Charlotte, North Carolina, United States, 28210
      • Char Eye Ear &Throat Assoc
    • Hickory, North Carolina, United States, 28602
      • Graystone Eye
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Eye Institute
    • Cleveland, Ohio, United States, 44122
      • Retina Assoc of Cleveland Inc
    • Columbus, Ohio, United States, 43212
      • The Ohio State University Havener Eye Institute
    • Dublin, Ohio, United States, 43016
      • Midwest Retina
  • Oregon
    • Portland, Oregon, United States, 97221
      • Retina Northwest
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Mid Atlantic Retina - Wills Eye Hospital
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Charleston Neuroscience Inst
    • West Columbia, South Carolina, United States, 29169
      • Palmetto Retina Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Eye Institute
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Southeastern Retina Associates Chattanooga
    • Germantown, Tennessee, United States, 38138
      • Charles Retina Institute
    • Nashville, Tennessee, United States, 37203
      • Tennessee Retina PC.
  • Texas
    • Abilene, Texas, United States, 79606
      • Retina Res Institute of Texas
    • Austin, Texas, United States, 78750
      • Austin Clinical Research LLC
    • Austin, Texas, United States, 78705-1169
      • Austin Retina Associates
    • Dallas, Texas, United States, 75231
      • Texas Retina Associates
    • Harlingen, Texas, United States, 78550
      • Valley Retina Institute P.A.
    • Southlake, Texas, United States, 76092
      • Retina Center of Texas
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Houston
    • The Woodlands, Texas, United States, 77384-4167
      • Retina Consultants of Texas
    • Willow Park, Texas, United States, 76087
      • Strategic Clinical Research Group, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Rocky Mountain Retina
    • Salt Lake City, Utah, United States, 84107
      • Retina Associates of Utah, PLLC
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Piedmont Eye Center
    • Norfolk, Virginia, United States, 23502
      • Wagner Kapoor Institute
  • Washington
    • Silverdale, Washington, United States, 98383
      • Retina Center Northwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for the Main Study:

• 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.

Inclusion Criteria for the Substudy:

• In addition to all inclusion criteria specified in the main Study GR42691, participants in the Substudy must meet the following criteria:
• 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

Exclusion Criteria for the Main Study:

• 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

Exclusion Criteria for the Substudy:

In addition to the exclusion criteria specified in the main Study GR42691, patients will be excluded from this substudy if they meet any of the following exclusion criteria:

• Prior and/or current administration of faricimab in the fellow (non-study) eye
• Prior administration of brolucizumab in the fellow (non-study) eye

Exclusion Criteria in Either Eye for the Substudy:

• 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
• Active or history of herpetic keratitis or kerato-uveitis (including herpes simplex virus and herpes zoster virus)
• Intraocular laser therapy including selective laser trabeculoplasty, yttrium-aluminum garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG capsulotomy within 3 months of screening
• Prior vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
• Prior pars plana vitrectomy surgery
• Previous intraocular device implantation excluding intraocular lenses
• Cataract surgery within 6 months of screening or planned for during the study
• History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery. Other types of prior glaucoma surgery are allowed providing that the surgery occur more than 6 months before screening
• Administration of topical Rho kinase inhibitors (e.g., Rhopressa eye drops) within 1 month prior to the screening visit
• Contact lens wear in either eye within 2 months of screening
• History of corneal transplantation, including partial-thickness corneal grafts (e.g., Descemet membrane endothelial keratoplasty, Descemet stripping endothelial keratoplasty)
• Active or history of iridocorneal endothelial syndrome
• Active or history of pseudoexfoliation syndrome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Main Study: Faricimab PTI	Drug: Faricimab; 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.; Other Names: RO6867461; RG7716; Other: Sham Procedure; 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.
Experimental: Substudy: Faricimab PTI	Drug: Faricimab; 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.; Other Names: RO6867461; RG7716

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main Study: Incidence and Severity of Ocular Adverse Events		Up to 2 years
Main Study: Incidence and Severity of Systemic (Non-Ocular) Adverse Events		Up to 2 years
Main Study: Number of Participants with Presence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study		From Baseline 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	1 Year is defined as the earliest substudy visit closest to Week 52 occurring between Week 48 and Week 64.	Baseline and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye	Week 24 is defined as the earliest substudy visit closest to Week 24 occurring between Week 20 and Week 28.	Baseline and Week 24

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Estimated): August 9, 2024
• Study Completion (Estimated): August 9, 2024

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Faricimab
• Other Study ID Numbers: GR42691; 2020-004523-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No