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

NCT06795048 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: MR456382024-517545-13-00
• Study Type: interventional
• Target: 274
• Locations: 12 countries
• Sites: 67

Brief 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.

Conditions

Neovascular Age-related Macular Degeneration (nAMD)

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Best-Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 44, 48, and 52

  Baseline and average of Weeks 44, 48, and 52

Secondary Outcomes (11)

• Change from Baseline in BCVA Score Averaged Over Weeks 92, 96, and 100

  Baseline and average of Weeks 92, 96, and 100

• Change from Baseline in BCVA Score Over Time

  From Baseline to Week 100

• Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time

  From Baseline to Week 100

• Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time

  From Baseline to Week 100

• Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time

  From Baseline to Week 100

Study Arms (2)

Arm A: Faricimab Early Treat & Extend Regimen

EXPERIMENTAL

Drug: Faricimab

Arm B: Faricimab Modified Treat & Extend Regimen

EXPERIMENTAL

Drug: Faricimab

Interventions

Faricimab DRUG

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.

Also known as: RO6867461, VABYSMO®

Arm A: Faricimab Early Treat & Extend Regimen; Arm B: Faricimab Modified Treat & Extend Regimen

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (67)

Orange County Retina Medical Group

Santa Ana, California, 92705, United States

Location

Florida Retina Institute

Orlando, Florida, 32806-1101, United States

Location

Ctr for Retina & Macular Dis

Winter Haven, Florida, 33880, United States

Location

Retinal Vitreal Consultants

Chicago, Illinois, 60616, United States

Location

University Retina and Macula Associates, PC

Lemont, Illinois, 60439, United States

Location

New England Retina Consultants

Springfield, Massachusetts, 01107, United States

Location

Sierra Eye Associates

Sparks, Nevada, 89434, United States

Location

Retina Associates of New Jersey

Teaneck, New Jersey, 07666, United States

Location

Vision Research Center at Eye Associates of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

Charles Retina Institute

Germantown, Tennessee, 38138, United States

Location

Retina Consultants of Texas

Schertz, Texas, 78154, United States

Location

Strathfield Retina Clinic

Strathfield, New South Wales, 2135, Australia

Location

Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

Location

Adelaide Eye and Retina Centre

Adelaide, South Australia, 5000, Australia

Location

Centre For Eye Research Australia

East Melbourne, Victoria, 3002, Australia

Location

Retina Specialists Victoria

Rowville, Victoria, 3178, Australia

Location

The Lions Eye Institute

Nedlands, Western Australia, 6009, Australia

Location

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

Retina Institute of Ottawa

Ottawa, Ontario, K2B 7E9, Canada

Location

Toronto Retina Institute

Toronto, Ontario, M3C 0G9, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Hopital du Saint Sacrement

Québec, Quebec, G1S 4L8, Canada

Location

Peking University People's Hospital

Beijing, 100044, China

Location

West China Hospital of Sichuan University

Chengdu, 610041, China

Location

Sichuan Provincial People's Hospital

Chengdu, 610072, China

Location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, 510060, China

Location

Eye and ENT hospital, Fudan University

Shanghai, China

Location

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

Wuhan, 430030, China

Location

Centre Retine Gallien

Bordeaux, 33000, France

Location

Hopital Edouard Herriot - CHU Lyon

Lyon, 69437, France

Location

Centre Ophtalmologique de L'Odeon

Paris, 75006, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

Centres Ophtalmologique St Exupéry

Saint-Cyr-sur-Loire, 37540, France

Location

Clinique de l'Union

Saint-Jean, 31240, France

Location

Augenzentrum Prof. Koch GmbH

Frankfurt, 60549, Germany

Location

Medizinische Hochschule Hannover, Klinik für Augenheilkunde

Hanover, 30625, Germany

Location

Augenzentrum am St Franziskus-Hospital

Münster, Germany

Location

Universitatsklinikum Ulm, Augenklinik und Poliklinik

Ulm, 89075, Germany

Location

Universitätsklinikum Würzburg, Augenklinik und Poliklinik

Würzburg, 97080, Germany

Location

Azienda ospedaliero universitaria Policlinico Riuniti di Foggia;SC Oculistica

Foggia, Apulia, 71122, Italy

Location

Azienda ospedaliero - universitaria Sant'Andrea;UOC Oculistica

Rome, Lazio, 00189, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

Location

Ospedale San Giuseppe

Milan, Lombardy, 20123, Italy

Location

Azienda Ospedaliera Universitaria "Luigi Vanvitelli";UOC Oculistica

Napoli, Sicily, 80138, Italy

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti

Torrette - Ancona, The Marches, 60126, Italy

Location

Singapore Eye Research Institute

Singapore, 168751, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Yeungnam Univ. Hospital

Daegu, 42415, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Hospital General de Catalunya

Sant Cugat de Valles, Barcelona, 08190, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Oftalvist

Burjassot, Valencia(España), Valencia, 46100, Spain

Location

Clinica Baviera

Madrid, 28046, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

China Medical University Hospital

Taichung, 404332, Taiwan

Location

National Taiwan University Hospital

Zhongzheng Dist., 10002, Taiwan

Location

Cardiff and Vale University Health Board

Cardiff, CF14 4XW, United Kingdom

Location

St James University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Liverpool University Hospitals NHS Foundation Trust

Liverpool, L7 8XP, United Kingdom

Location

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

Location

NewcastleUniversity& The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Interventions

faricimab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 27, 2025
• Study Start: March 14, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): September 16, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (5); ES (5); CN (6); TW (3); DE (5); KR (6); GB (6); IT (6); FR (6); SG (2); US (11); AU (6)