A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (AVONELLE-X)

October 9, 2025 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1036

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1015ABO
        • Organizacion Medica de Investigacion
      • CABA, Argentina, 1023
        • Fundacion Zambrano
      • Capital Federal, Argentina, C1120AAN
        • Oftalmos
      • Capital Federal, Argentina, C1116
        • Centro Oftalmologico Dr. Charles S.A.
      • Ciudad Autonoma Buenos Aires, Argentina, C1061AAE
        • Buenos Aires Mácula
      • Mendoza, Argentina, M5500GGK
        • Oftar
      • Rosario, Argentina, S2000DLA
        • Grupo Laser Vision
  • Australia
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Eyeclinic Albury Wodonga
      • 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
      • Vienna, Austria, 1090
        • Medizinische Universitat Wien
  • Brazil
    • Goiás
      • Aparecida de Goiânia, Goiás, Brazil, 74980-010
        • Hospital de Olhos de Aparecida - HOA
    • São Paulo
      • São Paulo, São Paulo, Brazil, 04023-062
        • Universidade Federal de Sao Paulo - UNIFESPX
  • 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
        • Retina Institute 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 Municipality, Denmark, 2600
        • Rigshospitalet Glostrup
      • Roskilde, Denmark, 4000
        • Sjællands Universitetshospital, Roskilde
  • France
      • Créteil, France, 94010
        • CHI de Créteil
      • Lyon, France, 69317
        • Hôpital de la Croix Rousse
      • Marseille, France, 13008
        • Centre Paradis Monticelli
      • Nantes, France, 44093
        • CHU Nantes - Hotel Dieu
      • Paris, France, 75010
        • Hôpital Lariboisière
      • Écully, France, 69130
        • Pole Vision Val d'Ouest
  • Germany
      • Cologne, Germany, 50937
        • Universitatsklinikum Koln
      • Düsseldorf, Germany, 40225
        • Universitätkslinikum Düsseldorf, Augenklinik
      • Freiburg im Breisgau, Germany, 79106
        • Universitätsklinikum Freiburg, Klinik für Augenheilkunde
      • Heidelberg, Germany, 69120
        • Universitätsklinik Heidelberg
      • Münster, Germany, 48149
        • Universitatsklinikum Munster
      • Münster, Germany, 48145
        • Augenabteilung am St. Franziskus-Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • The University of Hong Kong
      • Mong Kok, Hong Kong
        • Hong Kong Eye Hospital
  • Hungary
      • Budapest, Hungary, 1133
        • Budapest Retina Associates Kft.
      • Budapest, Hungary, 1106
        • Bajcsy-Zsilinszky Hospital
      • Budapest, Hungary, 1068
        • Észak-Pesti Centrumkórház - Honvédkórház
      • Debrecem, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Pécs, Hungary, 7621
        • Ganglion Medial Center
      • Szeged, Hungary, 6720
        • Szegedi Tudományegyetem ÁOK
      • Zalaegerszeg, Hungary, 8900
        • Zala Megyei Kórház
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah MC
      • Petah Tikva, Israel, 4941492
        • Rabin MC
      • Rehovot, Israel, 7660101
        • Kaplan Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky MC
  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00198
        • Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
    • Lombardy
      • Milan, Lombardy, Italy, 20100
        • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena
      • Milan, Lombardy, Italy, 20157
        • ASST Fatebenefratelli Sacco
    • Tuscany
      • Pisa, Tuscany, Italy, 56124
        • Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello
    • Umbria
      • Perugia, Umbria, Italy, 06129
        • Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia
  • 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
      • Hokkaido, Japan, 060-8604
        • Sapporo City General Hospital
      • Hokkaido, Japan, 078-8510
        • Asahikawa Medical University Hospital
      • Hyōgo, Japan, 663-8501
        • Hyogo Medical University Hospital
      • Hyōgo, 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
      • Miyagi, Japan, 960-1295
        • Fukushima Medical 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
  • Mexico
    • Mexico CITY (federal District)
      • Del. Cuauhtemoc, Mexico CITY (federal District), Mexico, 06760
        • Centro Oftalmológico Mira, S.C
      • Mexico City, Mexico CITY (federal District), Mexico, 01120
        • Macula Retina Consultores
    • Nuevo León
      • Monterrey Nuevo LEON, Nuevo León, 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
      • 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
      • Krakow, 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
      • Porto, Portugal, 4200-319
        • Hospital de Sao Joao
  • Russia
      • Novosibirsk, Russia, 630096
        • ?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch
    • Mariy-El Republic
      • Cheboksary, Mariy-El Republic, Russia, 428000
        • Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov
    • Moscow Oblast
      • Moscow, Moscow Oblast, Russia, 119435
        • FSBI ?Scientific Research Institute of Eye Diseases? of Russian Academy of medical Sciences
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 124044
        • Medical Military Academy n.a S.M.Kirov
      • Saint Petersburg, Sankt-Peterburg, Russia, 197022
        • 1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov
    • Tatarstan Republic
      • Kazan', Tatarstan Republic, Russia, 420066
        • Clinics of Eye Diseases, LLC
  • Singapore
      • Singapore, Singapore, 168751
        • Singapore Eye Research Institute
  • South Korea
      • Busan, South Korea, 49241
        • Pusan National University Hospital
      • Daegu, South Korea, 42415
        • Yeungnam University Medical Center
      • Seongnam-si, South Korea, 13605
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 02447
        • Kyung Hee University Hospital
      • Seoul, South Korea, (0)6351
        • Samsung Medical Center
      • Seoul, South Korea, 06192
        • Nune Eye Hospital
  • Spain
      • Barcelona, Spain, 08022
        • Institut de la Macula i la retina
      • Barcelona, Spain, 08028
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08025
        • Hospital dos de maig
      • Madrid, Spain, 28046
        • Clinica Baviera
      • Valladolid, Spain, 47012
        • Hospital Universitario Rio Hortega
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
      • San Cugat Del Valles, Barcelona, Spain, 08195
        • Hospital General de Catalunya
    • LA Coruna
      • Santiago de Compostela, LA Coruna, Spain, 15706
        • Instituto Oftalmologico Gomez Ulla
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universitaria de Navarra
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33012
        • Instituto Oftalmologico Fernandez Vega
    • Valencia
      • Burjassot, Valencia, Spain, 46100
        • Oftalvist Valencia
  • Switzerland
      • Binningen, Switzerland, 4102
        • Vista Klinik Ophthalmologische Klinik
  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Christian Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan District, Taiwan, 333
        • Chang Gung Medical Foundation - Linkou
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Hacettepe University Medical Faculty
      • Ankara, Turkey (Türkiye), 06340
        • Ankara University Medical Faculty
      • Ankara, Turkey (Türkiye), 06490
        • Ankara Baskent University Medical Faculty
      • Ankara, Turkey (Türkiye), 06560
        • Gazi University Faculty of Medicine
      • Izmir, Turkey (Türkiye), 35100
        • Ege University Medical Faculty
      • Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli University Medical Faculty
      • Konya, Turkey (Türkiye), 42130
        • Selçuk University Faculty of Medicine
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Opthalmology Research Office
      • Bristol, United Kingdom, BS1 2LX
        • Bristol Eye Hospital
      • 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 8XP
        • Royal Liverpool University Hospital
      • 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
      • 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
      • St. 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
        • 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, 21204
        • Retina Specialists
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Med
      • Chevy Chase, Maryland, United States, 20815
        • Retina Group of Washington
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • VitreoRetinal Surgery, PLLC.
    • 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
      • Cherry Hill, New Jersey, United States, 08034
        • Mid Atlantic Retina - Wills Eye Hospital
      • Edison, New Jersey, United States, 08820
        • NJ Retina
      • Teaneck, New Jersey, United States, 07666
        • Retina Associates of NJ
    • New York
      • Great Neck, New York, United States, 11021
        • Long Is. Vitreoretinal Consult
      • 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
        • Vitreoretinal Consultants of New York
      • Slingerlands, New York, United States, 12159
        • The Retina Consultants
      • Syracuse, New York, United States, 13224
        • Retina Vit Surgeons/Central NY
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Western Carolina Retinal Associate PA
      • Charlotte, North Carolina, United States, 28210
        • Char Eye Ear &Throat Assoc
      • Winston-Salem, North Carolina, United States, 27104
        • Graystone Eye
    • Ohio
      • Blue Ash, Ohio, United States, 45242-5537
        • 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
    • 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, 78705
        • Austin Retina Associates
      • Austin, Texas, United States, 78750
        • Austin Clinical Research LLC
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • Houston, Texas, United States, 77030
        • Retina Consultants of Texas
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute P.A.
      • Southlake, Texas, United States, 76092
        • Retina Center Of Texas
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Houston
      • 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, 23451
        • Wagner Kapoor Institute
    • Washington
      • Silverdale, Washington, United States, 98383
        • Pacific Northwest Retina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Anti-VEGF Therapy
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.
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
Drug: Anti-VEGF Therapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
Time Frame: From the date of first administration of faricimab through 28 days after the end of study (up to 2 years)
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
Time Frame: From the date of first administration of faricimab through 28 days after the end of study (up to 2 years)
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
Time Frame: From the date of first administration of faricimab through 28 days after the end of study (up to 2 years)
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
Time Frame: Baseline and 1 year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: Baseline and Week 24
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 Week 24 timepoint was defined as the earliest substudy visit closest to Week 24 occurring between Week 20 and Week 28. 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 Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 3, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 3, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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 clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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