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
Status: Recruiting
Location: See all (69) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• Overtly healthy as determined by medical evaluation that includes medical history and 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-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
Locations
United States
California
Retinal Diagnostic Center
RECRUITING
Campbell
Orange County Retina Medical Group
RECRUITING
Santa Ana
Florida
Florida Retina Institute
RECRUITING
Orlando
Ctr for Retina & Macular Dis
RECRUITING
Winter Haven
Illinois
Retinal Vitreal Consultants
RECRUITING
Chicago
University Retina and Macula Associates, PC
RECRUITING
Lemont
Massachusetts
New England Retina Consultants
RECRUITING
Springfield
New Jersey
Retina Associates of New Jersey
RECRUITING
Teaneck
New Mexico
Vision Research Center at Eye Associates of New Mexico
RECRUITING
Albuquerque
Nevada
Sierra Eye Associates
RECRUITING
Sparks
South Dakota
Black Hills Eye Institute
RECRUITING
Rapid City
Tennessee
Charles Retina Institute
RECRUITING
Germantown
Texas
Retina Consultants of Texas
RECRUITING
Schertz
Other Locations
Australia
Adelaide Eye and Retina Centre
RECRUITING
Adelaide
Centre For Eye Research Australia
RECRUITING
East Melbourne
The Lions Eye Institute
RECRUITING
Nedlands
Retina Specialists Victoria
RECRUITING
Rowville
Strathfield Retina Clinic
RECRUITING
Strathfield
Sydney Eye Hospital
RECRUITING
Sydney
Canada
St. Joseph's Health Care
RECRUITING
London
Retina Institute of Ottawa
RECRUITING
Ottawa
Hopital du Saint Sacrement
RECRUITING
Québec
Toronto Retina Institute
RECRUITING
Toronto
Toronto Western Hospital
RECRUITING
Toronto
China
Peking University People's Hospital
RECRUITING
Beijing
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
West China Hospital of Sichuan University
RECRUITING
Chengdu
Zhongshan Ophthalmic Center, Sun Yat-sen University
RECRUITING
Guangzhou
Eye and ENT hospital, Fudan University
RECRUITING
Shanghai
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
RECRUITING
Wuhan
France
Centre Retine Gallien
RECRUITING
Bordeaux
Hopital Edouard Herriot - CHU Lyon
RECRUITING
Lyon
Centre Ophtalmologique de L'Odeon
RECRUITING
Paris
Hopital Lariboisiere
RECRUITING
Paris
Centres Ophtalmologique St Exupéry
RECRUITING
Saint-cyr-sur-loire
Clinique de l'Union
RECRUITING
Saint-jean
Germany
Augenzentrum Prof. Koch GmbH
RECRUITING
Frankfurt
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
RECRUITING
Hanover
Augenzentrum am St Franziskus-Hospital
RECRUITING
Münster
Universitätsmedizin Rostock
RECRUITING
Rostock
Universitatsklinikum Ulm, Augenklinik und Poliklinik
RECRUITING
Ulm
Universitätsklinikum Würzburg, Augenklinik und Poliklinik
RECRUITING
Würzburg
Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
Ospedale San Giuseppe
RECRUITING
Milan
Azienda Ospedaliera Universitaria Luigi Vanvitelli;UOC Oculistica
RECRUITING
Napoli
Azienda ospedaliero - universitaria Sant'Andrea;UOC Oculistica
RECRUITING
Rome
Azienda Ospedaliero Universitaria Ospedali Riuniti
RECRUITING
Torrette - Ancona
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Yeungnam Univ. Hospital
RECRUITING
Daegu
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Singapore
Singapore Eye Research Institute
RECRUITING
Singapore
Tan Tock Seng Hospital
RECRUITING
Singapore
Spain
Oftalvist
RECRUITING
Burjassot, Valencia(españa)
Clinica Baviera
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro
RECRUITING
Majadahonda
Hospital General de Catalunya
RECRUITING
Sant Cugat De Valles
Hospital Universitario Virgen del Rocio - Servicio de Oftalmologia;Servicio de Oftalmologia
RECRUITING
Seville
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
China Medical University Hospital
RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Zhongzheng Dist.
United Kingdom
Cardiff and Vale University Health Board
RECRUITING
Cardiff
St James University Hospital
RECRUITING
Leeds
Liverpool University Hospitals NHS Foundation Trust
RECRUITING
Liverpool
Moorfields Eye Hospital NHS Foundation Trust
RECRUITING
London
NewcastleUniversity& The Newcastle upon Tyne Hospitals NHS Foundation Trust
RECRUITING
Newcastle Upon Tyne
New Cross Hospital
RECRUITING
Wolverhampton
Contact Information
Primary
Reference Study ID Number: MR45638 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date: 2025-03-14
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 274
Treatments
Experimental: Arm A: Faricimab Early Treat & Extend Regimen
Experimental: Arm B: Faricimab Modified Treat & Extend Regimen
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche