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A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
Sponsor: Hoffmann-La Roche
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.
Official title: A Phase IIIb/IV, Multicenter, Randomized, Open-Label, Two-Arm Study to Investigate the Efficacy, Safety, and Durability of Faricimab Administered up to Every 24 Weeks in Patients With Neovascular Age-Related Macular Degeneration
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
274
Start Date
2025-03-14
Completion Date
2027-09-16
Last Updated
2026-02-02
Healthy Volunteers
No
Interventions
Faricimab
Participants will receive 6-mg faricimab intravitreal (IVT) injections in the study eye according to the dosing regimen for the study arm to which they are randomized.
Locations (67)
Orange County Retina Medical Group
Santa Ana, California, United States
Florida Retina Institute
Orlando, Florida, United States
Ctr for Retina & Macular Dis
Winter Haven, Florida, United States
Retinal Vitreal Consultants
Chicago, Illinois, United States
University Retina and Macula Associates, PC
Lemont, Illinois, United States
New England Retina Consultants
Springfield, Massachusetts, United States
Sierra Eye Associates
Sparks, Nevada, United States
Retina Associates of New Jersey
Teaneck, New Jersey, United States
Vision Research Center at Eye Associates of New Mexico
Albuquerque, New Mexico, United States
Charles Retina Institute
Germantown, Tennessee, United States
Retina Consultants of Texas
Schertz, Texas, United States
Strathfield Retina Clinic
Strathfield, New South Wales, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
Adelaide Eye and Retina Centre
Adelaide, South Australia, Australia
Centre For Eye Research Australia
East Melbourne, Victoria, Australia
Retina Specialists Victoria
Rowville, Victoria, Australia
The Lions Eye Institute
Nedlands, Western Australia, Australia
St. Joseph's Health Care
London, Ontario, Canada
Retina Institute of Ottawa
Ottawa, Ontario, Canada
Toronto Retina Institute
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Hopital du Saint Sacrement
Québec, Quebec, Canada
Peking University People's Hospital
Beijing, China
West China Hospital of Sichuan University
Chengdu, China
Sichuan Provincial People's Hospital
Chengdu, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, China
Eye and ENT hospital, Fudan University
Shanghai, China
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, China
Centre Retine Gallien
Bordeaux, France
Hopital Edouard Herriot - CHU Lyon
Lyon, France
Centre Ophtalmologique de L'Odeon
Paris, France
Hopital Lariboisiere
Paris, France
Centres Ophtalmologique St Exupéry
Saint-Cyr-sur-Loire, France
Clinique de l'Union
Saint-Jean, France
Augenzentrum Prof. Koch GmbH
Frankfurt, Germany
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover, Germany
Augenzentrum am St Franziskus-Hospital
Münster, Germany
Universitatsklinikum Ulm, Augenklinik und Poliklinik
Ulm, Germany
Universitätsklinikum Würzburg, Augenklinik und Poliklinik
Würzburg, Germany
Azienda ospedaliero universitaria Policlinico Riuniti di Foggia;SC Oculistica
Foggia, Apulia, Italy
Azienda ospedaliero - universitaria Sant'Andrea;UOC Oculistica
Rome, Lazio, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Ospedale San Giuseppe
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria "Luigi Vanvitelli";UOC Oculistica
Napoli, Sicily, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette - Ancona, The Marches, Italy
Singapore Eye Research Institute
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
Pusan National University Hospital
Busan, South Korea
Yeungnam Univ. Hospital
Daegu, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Hospital General de Catalunya
Sant Cugat de Valles, Barcelona, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Oftalvist
Burjassot, Valencia(España), Valencia, Spain
Clinica Baviera
Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Taiwan University Hospital
Zhongzheng Dist., Taiwan
Cardiff and Vale University Health Board
Cardiff, United Kingdom
St James University Hospital
Leeds, United Kingdom
Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom
NewcastleUniversity& The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom