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: Active_not_recruiting
Location: See all (68) 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
Orange County Retina Medical Group
Santa Ana
Florida
Florida Retina Institute
Orlando
Ctr for Retina & Macular Dis
Winter Haven
Illinois
Retinal Vitreal Consultants
Chicago
University Retina and Macula Associates, PC
Lemont
Massachusetts
New England Retina Consultants
Springfield
New Jersey
Retina Associates of New Jersey
Teaneck
New Mexico
Vision Research Center at Eye Associates of New Mexico
Albuquerque
Nevada
Sierra Eye Associates
Sparks
Tennessee
Charles Retina Institute
Germantown
Texas
Retina Consultants of Texas
Schertz
Other Locations
Australia
Adelaide Eye and Retina Centre
Adelaide
Centre For Eye Research Australia
East Melbourne
The Lions Eye Institute
Nedlands
Retina Specialists Victoria
Rowville
Strathfield Retina Clinic
Strathfield
Sydney Eye Hospital
Sydney
Canada
St. Joseph's Health Care
London
Retina Institute of Ottawa
Ottawa
Hopital du Saint Sacrement
Québec
Toronto Retina Institute
Toronto
Toronto Western Hospital
Toronto
China
Peking University People's Hospital
Beijing
Sichuan Provincial People's Hospital
Chengdu
West China Hospital of Sichuan University
Chengdu
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou
Eye and ENT hospital, Fudan University
Shanghai
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan
France
Centre Retine Gallien
Bordeaux
Hopital Edouard Herriot - CHU Lyon
Lyon
Centre Ophtalmologique de L'Odeon
Paris
Hopital Lariboisiere
Paris
Centres Ophtalmologique St Exupéry
Saint-cyr-sur-loire
Clinique de l'Union
Saint-jean
Germany
Augenzentrum Prof. Koch GmbH
Frankfurt
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover
Augenzentrum am St Franziskus-Hospital
Münster
Universitätsmedizin Rostock
Rostock
Universitatsklinikum Ulm, Augenklinik und Poliklinik
Ulm
Universitätsklinikum Würzburg, Augenklinik und Poliklinik
Würzburg
Italy
Azienda ospedaliero universitaria Policlinico Riuniti di Foggia;SC Oculistica
Foggia
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan
Ospedale San Giuseppe
Milan
Azienda Ospedaliera Universitaria Luigi Vanvitelli;UOC Oculistica
Napoli
Azienda ospedaliero - universitaria Sant'Andrea;UOC Oculistica
Rome
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette - Ancona
Republic of Korea
Pusan National University Hospital
Busan
Yeungnam Univ. Hospital
Daegu
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Singapore
Singapore Eye Research Institute
Singapore
Tan Tock Seng Hospital
Singapore
Spain
Oftalvist
Burjassot, Valencia(españa)
Clinica Baviera
Madrid
Hospital Universitario Puerta de Hierro
Majadahonda
Hospital General de Catalunya
Sant Cugat De Valles
Hospital Universitario Virgen del Rocio - Servicio de Oftalmologia;Servicio de Oftalmologia
Seville
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
China Medical University Hospital
Taichung
National Taiwan University Hospital
Zhongzheng Dist.
United Kingdom
Cardiff and Vale University Health Board
Cardiff
St James University Hospital
Leeds
Liverpool University Hospitals NHS Foundation Trust
Liverpool
Moorfields Eye Hospital NHS Foundation Trust
London
NewcastleUniversity& The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne
New Cross Hospital
Wolverhampton
Time Frame
Start Date: 2025-03-14
Completion Date: 2027-09-16
Participants
Target number of participants: 274
Treatments
Experimental: Arm A: Faricimab Early Treat & Extend Regimen
Experimental: Arm B: Faricimab Modified Treat & Extend Regimen
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov

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