A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

Last updated: October 31, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

4

Condition

Macular Degeneration

Geographic Atrophy

Treatment

Faricimab

Clinical Study ID

NCT06795048
MR45638
2024-517545-13-00
  • Ages > 50
  • All Genders

Study Summary

This study is a Phase IIIb/IV, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (nAMD) that are treatment-naïve in the study eye.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Overtly healthy as determined by medical evaluation that includes medical historyand physical examination

  • Agreement to adhere to the contraception requirements described in the protocol

Ocular Inclusion Criteria for Study Eye:

  • Active treatment-naïve macular neovascularization (MNV) secondary to age-relatedmacular degeneration (AMD), confirmed by the investigator based on the presence ofintraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield onoptical coherence tomography (OCT)

  • BCVA of 83 to 24 letters, inclusive (20/25 to 20/320 approximate Snellen equivalent,using the early treatment diabetic retinopathy study [ETDRS] protocol and addressedat the initial testing distance of 4 meters on Day 1)

  • Sufficiently clear ocular media and adequate pupillary dilation to allow acquisitionof good quality retinal images to confirm diagnosis

Exclusion

Exclusion Criteria:

Ocular Exclusion Criteria for Study Eye:

  • MNV due to causes other than nAMD, such as ocular histoplasmosis, trauma,pathological myopia, angioid streaks, choroidal rupture, or uveitis

  • Retinal pigment epithelial tear involving the macula on Day 1

  • Current vitreous hemorrhage on Day 1

  • Prior periocular pharmacological or IVT treatment (including faricimab,anti-vascular endothelial growth factor [VEGF], or complement inhibitor medication)for other retinal diseases

Ocular Exclusion Criteria for Fellow (Non-Study) Eye:

  • Participants who have a nonfunctioning fellow (non-study) eye, defined as eitherBCVA of hand motion or worse, or no physical presence of non-study eye (i.e.,monocular), at both the screening and study Day 1 visits

Ocular Exclusion for Both Eyes:

  • History of idiopathic or autoimmune associated uveitis in either eye

  • Active ocular inflammation or suspected or active ocular or periocular infection ineither eye on study Day 1

Study Design

Total Participants: 274
Treatment Group(s): 1
Primary Treatment: Faricimab
Phase: 4
Study Start date:
March 14, 2025
Estimated Completion Date:
September 16, 2027

Connect with a study center

  • Strathfield Retina Clinic

    Strathfield, New South Wales 2135
    Australia

    Site Not Available

  • Sydney Eye Hospital

    Sydney, New South Wales 2000
    Australia

    Site Not Available

  • Strathfield Retina Clinic

    Strathfield 2148088, New South Wales 2155400 2135
    Australia

    Site Not Available

  • Sydney Eye Hospital

    Sydney 2147714, New South Wales 2155400 2000
    Australia

    Site Not Available

  • Adelaide Eye and Retina Centre

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Adelaide Eye and Retina Centre

    Adelaide 2078025, South Australia 2061327 5000
    Australia

    Site Not Available

  • Centre For Eye Research Australia

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Retina Specialists Victoria

    Rowville, Victoria 3178
    Australia

    Site Not Available

  • Centre For Eye Research Australia

    East Melbourne 6952201, Victoria 2145234 3002
    Australia

    Site Not Available

  • Retina Specialists Victoria

    Rowville 2150894, Victoria 2145234 3178
    Australia

    Site Not Available

  • The Lions Eye Institute

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • The Lions Eye Institute

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Site Not Available

  • St. Joseph's Health Care

    London, Ontario N6A 4V2
    Canada

    Site Not Available

  • Retina Institute of Ottawa

    Ottawa, Ontario K2B 7E9
    Canada

    Site Not Available

  • Toronto Retina Institute

    Toronto, Ontario M3C 0G9
    Canada

    Active - Recruiting

  • Toronto Western Hospital

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

  • St. Joseph's Health Care

    London 6058560, Ontario 6093943 N6A 4V2
    Canada

    Site Not Available

  • Retina Institute of Ottawa

    Ottawa 6094817, Ontario 6093943 K2B 7E9
    Canada

    Site Not Available

  • Toronto Retina Institute

    Toronto 6167865, Ontario 6093943 M3C 0G9
    Canada

    Site Not Available

  • Toronto Western Hospital

    Toronto 6167865, Ontario 6093943 M5T 2S8
    Canada

    Site Not Available

  • Hopital du Saint Sacrement

    Québec 6325494, Quebec 6115047 G1S 4L8
    Canada

    Site Not Available

  • Peking University People's Hospital

    Beijing, 100044
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing 1816670, 100044
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu, 610072
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu 1815286, 610072
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu 1815286, 610041
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu City, 610041
    China

    Site Not Available

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou 1809858, 510060
    China

    Site Not Available

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou City, 510060
    China

    Site Not Available

  • Eye and ENT hospital, Fudan University

    Shanghai,
    China

    Site Not Available

  • Eye and ENT hospital, Fudan University

    Shanghai 1796236,
    China

    Site Not Available

  • Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

    Wuhan, 430030
    China

    Site Not Available

  • Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

    Wuhan 1791247, 430030
    China

    Site Not Available

  • Centre Retine Gallien

    Bordeaux 3031582, 33000
    France

    Site Not Available

  • Centre Rétine Gallien

    Bordeaux 3031582, 33000
    France

    Active - Recruiting

  • Hopital Edouard Herriot - CHU Lyon

    Lyon 2996944, 69437
    France

    Site Not Available

  • Centre Ophtalmologique de L'Odeon

    Paris 2988507, 75006
    France

    Site Not Available

  • Hopital Lariboisiere

    Paris 2988507, 75010
    France

    Site Not Available

  • Centres Ophtalmologique St Exupéry

    Saint-Cyr-sur-Loire 2980935, 37540
    France

    Site Not Available

  • Clinique de l'Union

    Saint-Jean 2979394, 31240
    France

    Site Not Available

  • Augenzentrum Prof. Koch GmbH

    Frankfurt, 60549
    Germany

    Site Not Available

  • Augenzentrum Prof. Koch GmbH

    Frankfurt 2925536, 60549
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover, Klinik für Augenheilkunde

    Hannover, 30625
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover, Klinik für Augenheilkunde

    Hanover 2910831, 30625
    Germany

    Site Not Available

  • Augenzentrum am St Franziskus-Hospital

    Münster,
    Germany

    Site Not Available

  • Augenzentrum am St Franziskus-Hospital

    Münster 2867543,
    Germany

    Site Not Available

  • Universitätsmedizin Rostock

    Rostock 2844588, 18057
    Germany

    Site Not Available

  • Universitätsklinikum Ulm, Augenklinik und Poliklinik

    Ulm, 89075
    Germany

    Site Not Available

  • Universitatsklinikum Ulm, Augenklinik und Poliklinik

    Ulm 2820256, 89075
    Germany

    Site Not Available

  • Universitätsklinikum Ulm, Augenklinik und Poliklinik

    Ulm 2820256, 89075
    Germany

    Active - Recruiting

  • Universitätsklinikum Würzburg, Augenklinik und Poliklinik

    Würzburg 2805615, 97080
    Germany

    Site Not Available

  • Azienda ospedaliero universitaria Policlinico Riuniti di Foggia;SC Oculistica

    Foggia 3176885, Apulia 3169778 71122
    Italy

    Site Not Available

  • Azienda ospedaliero - universitaria Sant'Andrea;UOC Oculistica

    Roma, Lazio 00189
    Italy

    Site Not Available

  • Azienda ospedaliero - universitaria Sant'Andrea;UOC Oculistica

    Rome 3169070, Lazio 3174976 00189
    Italy

    Site Not Available

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milano, Lombardia 20122
    Italy

    Active - Recruiting

  • Ospedale San Giuseppe

    Milano, Lombardia 20123
    Italy

    Site Not Available

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan 3173435, Lombardy 3174618 20122
    Italy

    Site Not Available

  • Ospedale San Giuseppe

    Milan 3173435, Lombardy 3174618 20123
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria "Luigi Vanvitelli";UOC Oculistica

    Napoli, Sicily 2523119 80138
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Torrette - Ancona, The Marches 3174004 60126
    Italy

    Site Not Available

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Site Not Available

  • Yeungnam Univ. Hospital

    Daegu, 42415
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Singapore Eye Research Institute

    Singapore, 168751
    Singapore

    Active - Recruiting

  • Tan Tock Seng Hospital

    Singapore, 308433
    Singapore

    Site Not Available

  • Singapore Eye Research Institute

    Singapore 1880252, 168751
    Singapore

    Site Not Available

  • Tan Tock Seng Hospital

    Singapore 1880252, 308433
    Singapore

    Site Not Available

  • Pusan National University Hospital

    Busan 1838524, 49241
    South Korea

    Site Not Available

  • Yeungnam Univ. Hospital

    Daegu 1835329, 42415
    South Korea

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si 1897000, 13620
    South Korea

    Site Not Available

  • Asan Medical Center

    Seoul 1835848, 05505
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • Hospital General de Catalunya

    Sant Cugat de Valles, Barcelona 08190
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Majadahonda 3117667, Madrid 3117732 28222
    Spain

    Site Not Available

  • Oftalvist

    Burjassot, Valencia(España), Valencia 2593113 46100
    Spain

    Site Not Available

  • Clinica Baviera

    Madrid, 28046
    Spain

    Site Not Available

  • Clinica Baviera

    Madrid 3117735, 28046
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio - Servicio de Oftalmologia;Servicio de Oftalmologia

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio - Servicio de Oftalmologia;Servicio de Oftalmologia

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung,
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City 1673820,
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 404332
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung 1668399, 404332
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Zhongzheng Dist., 10002
    Taiwan

    Site Not Available

  • Cardiff and Vale University Health Board

    Cardiff 2653822, CF14 4XW
    United Kingdom

    Site Not Available

  • St James University Hospital

    Leeds 2644688, LS9 7TF
    United Kingdom

    Site Not Available

  • Liverpool University Hospitals NHS Foundation Trust

    Liverpool 2644210, L7 8XP
    United Kingdom

    Site Not Available

  • Moorfields Eye Hospital NHS Foundation Trust

    London 2643743, EC1V 2PD
    United Kingdom

    Site Not Available

  • NewcastleUniversity& The Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne 2641673, NE1 4LP
    United Kingdom

    Site Not Available

  • New Cross Hospital

    Wolverhampton 2633691, WV10 0QP
    United Kingdom

    Site Not Available

  • Retinal Diagnostic Center

    Campbell, California 95008
    United States

    Site Not Available

  • Orange County Retina Medical Group

    Santa Ana, California 92705
    United States

    Site Not Available

  • Retinal Diagnostic Center

    Campbell 5333689, California 5332921 95008
    United States

    Site Not Available

  • Orange County Retina Medical Group

    Santa Ana 5392900, California 5332921 92705
    United States

    Site Not Available

  • Florida Retina Institute

    Orlando, Florida 32806-1101
    United States

    Site Not Available

  • Ctr for Retina & Macular Dis

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Florida Retina Institute

    Orlando 4167147, Florida 4155751 32806-1101
    United States

    Site Not Available

  • Ctr for Retina & Macular Dis

    Winter Haven 4178552, Florida 4155751 33880
    United States

    Site Not Available

  • Retinal Vitreal Consultants

    Chicago, Illinois 60616
    United States

    Site Not Available

  • University Retina and Macula Associates, PC

    Lemont, Illinois 60439
    United States

    Site Not Available

  • Retinal Vitreal Consultants

    Chicago 4887398, Illinois 4896861 60616
    United States

    Site Not Available

  • University Retina and Macula Associates, PC

    Lemont 4899581, Illinois 4896861 60439
    United States

    Site Not Available

  • New England Retina Consultants

    Springfield, Massachusetts 01107
    United States

    Site Not Available

  • New England Retina Consultants

    Springfield 4951788, Massachusetts 6254926 01107
    United States

    Site Not Available

  • Sierra Eye Associates

    Sparks, Nevada 89434
    United States

    Site Not Available

  • Sierra Eye Associates

    Sparks 5512862, Nevada 5509151 89434
    United States

    Site Not Available

  • Retina Associates of New Jersey

    Teaneck 5105262, New Jersey 5101760 07666
    United States

    Site Not Available

  • Vision Research Center at Eye Associates of New Mexico

    Albuquerque 5454711, New Mexico 5481136 87109
    United States

    Site Not Available

  • Black Hills Eye Institute

    Rapid City 5768233, South Dakota 5769223 57701
    United States

    Site Not Available

  • Charles Retina Institute

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Charles Retina Institute

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Site Not Available

  • Retina Consultants of Texas

    Schertz, Texas 78154
    United States

    Site Not Available

  • Retina Consultants of Texas

    Schertz 4727326, Texas 4736286 78154
    United States

    Site Not Available

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