A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
NCT ID: NCT06795048
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
274 participants
INTERVENTIONAL
2025-03-14
2027-09-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Faricimab Early Treat & Extend Regimen
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.
Arm B: Faricimab Modified Treat & Extend Regimen
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Agreement to adhere to the contraception requirements described in the protocol
* Active treatment-naïve macular neovascularization (MNV) secondary to age-related macular degeneration (AMD), confirmed by the investigator based on the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield on optical 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 addressed at the initial testing distance of 4 meters on Day 1)
* Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis
Exclusion Criteria
* 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
* Participants who have a nonfunctioning fellow (non-study) eye, defined as either BCVA 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 in either eye on study Day 1
50 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Universitätsmedizin Rostock
Rostock, , 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 - Servicio de Oftalmologia;Servicio de Oftalmologia
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
Countries
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Other Identifiers
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2024-517545-13-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
MR45638
Identifier Type: -
Identifier Source: org_study_id
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