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

April 29, 2026 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

274

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Strathfield, New South Wales, Australia, 2135
        • Strathfield Retina Clinic
      • Sydney, New South Wales, Australia, 2000
        • Sydney Eye Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Adelaide Eye and Retina Centre
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Centre for Eye Research Australia
      • Rowville, Victoria, Australia, 3178
        • Retina Specialists Victoria
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • The Lions Eye Institute
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Health Care
      • Ottawa, Ontario, Canada, K2B 7E9
        • Retina Institute of Ottawa
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
      • Toronto, Ontario, Canada, M3C 0G9
        • Toronto Retina Institute
    • Quebec
      • Québec, Quebec, Canada, G1S 4L8
        • Hopital du Saint Sacrement
  • China
      • Beijing, China, 100044
        • Peking University People's Hospital
      • Chengdu, China, 610041
        • West China Hospital of Sichuan University
      • Chengdu, China, 610072
        • Sichuan Provincial People's Hospital
      • Guangzhou, China, 510060
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Shanghai, China
        • Eye and ENT Hospital, Fudan University
      • Wuhan, China, 430030
        • Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
  • France
      • Bordeaux, France, 33000
        • Centre Retine Gallien
      • Lyon, France, 69437
        • Hopital Edouard Herriot - CHU Lyon
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Paris, France, 75006
        • Centre Ophtalmologique de L'Odeon
      • Saint-Cyr-sur-Loire, France, 37540
        • Centres Ophtalmologique St Exupéry
      • Saint-Jean, France, 31240
        • Clinique de l'Union
  • Germany
      • Frankfurt, Germany, 60549
        • Augenzentrum Prof. Koch GmbH
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover, Klinik für Augenheilkunde
      • Münster, Germany
        • Augenzentrum am St Franziskus-Hospital
      • Ulm, Germany, 89075
        • Universitatsklinikum Ulm, Augenklinik und Poliklinik
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg, Augenklinik und Poliklinik
  • Italy
    • Apulia
      • Foggia, Apulia, Italy, 71122
        • Azienda ospedaliero universitaria Policlinico Riuniti di Foggia;SC Oculistica
    • Lazio
      • Rome, Lazio, Italy, 00189
        • Azienda ospedaliero - universitaria Sant'Andrea;UOC Oculistica
    • Lombardy
      • Milan, Lombardy, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Milan, Lombardy, Italy, 20123
        • Ospedale San Giuseppe
    • Sicily
      • Napoli, Sicily, Italy, 80138
        • Azienda Ospedaliera Universitaria "Luigi Vanvitelli";UOC Oculistica
    • The Marches
      • Torrette - Ancona, The Marches, Italy, 60126
        • Azienda Ospedaliero Universitaria Ospedali Riuniti
  • Singapore
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital
      • Singapore, Singapore, 168751
        • Singapore Eye Research Institute
  • South Korea
      • Busan, South Korea, 49241
        • Pusan National University Hospital
      • Daegu, South Korea, 42415
        • Yeungnam Univ. Hospital
      • Seongnam-si, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
  • Spain
      • Madrid, Spain, 28046
        • Clinica Baviera
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
    • Barcelona
      • Sant Cugat de Valles, Barcelona, Spain, 08190
        • Hospital General de Catalunya
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro
    • Valencia
      • Burjassot, Valencia(España), Valencia, Spain, 46100
        • Oftalvist
  • Taiwan
      • Kaohsiung City, Taiwan
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 404332
        • China Medical University Hospital
      • Zhongzheng Dist., Taiwan, 10002
        • National Taiwan University Hospital
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • Cardiff And Vale University Health Board
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • Liverpool, United Kingdom, L7 8XP
        • Liverpool University Hospitals NHS Foundation Trust
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital NHS Foundation Trust
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • NewcastleUniversity& The Newcastle upon Tyne Hospitals NHS Foundation Trust
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital
  • United States
    • California
      • Santa Ana, California, United States, 92705
        • Orange County Retina Medical Group
    • Florida
      • Orlando, Florida, United States, 32806-1101
        • Florida Retina Institute
      • Winter Haven, Florida, United States, 33880
        • Ctr for Retina & Macular Dis
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Retinal Vitreal Consultants
      • Lemont, Illinois, United States, 60439
        • University Retina and Macula Associates, PC
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • New England Retina Consultants
    • Nevada
      • Sparks, Nevada, United States, 89434
        • Sierra Eye Associates
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Retina Associates of New Jersey
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Vision Research Center at Eye Associates of New Mexico
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Charles Retina Institute
    • Texas
      • Schertz, Texas, United States, 78154
        • Retina Consultants of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

Ocular Exclusion Criteria for Study Eye:

  • 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

Ocular Exclusion Criteria for Fellow (Non-Study) Eye:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Faricimab Early Treat & Extend Regimen
Drug: 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 Names:
  • RO6867461
  • VABYSMO®
Experimental: Arm B: Faricimab Modified Treat & Extend Regimen
Drug: 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 Names:
  • RO6867461
  • VABYSMO®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Best-Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 44, 48, and 52
Time Frame: Baseline and average of Weeks 44, 48, and 52
Baseline and average of Weeks 44, 48, and 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in BCVA Score Averaged Over Weeks 92, 96, and 100
Time Frame: Baseline and average of Weeks 92, 96, and 100
Baseline and average of Weeks 92, 96, and 100
Change from Baseline in BCVA Score Over Time
Time Frame: From Baseline to Week 100
From Baseline to Week 100
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time
Time Frame: From Baseline to Week 100
From Baseline to Week 100
Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time
Time Frame: From Baseline to Week 100
From Baseline to Week 100
Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time
Time Frame: From Baseline to Week 100
From Baseline to Week 100
Change from Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44, 48, and 52
Time Frame: Baseline and average of Weeks 44, 48, and 52
Baseline and average of Weeks 44, 48, and 52
Change from Baseline in CST Averaged Over Weeks 92, 96, and 100
Time Frame: Baseline and average of Weeks 92, 96, and 100
Baseline and average of Weeks 92, 96, and 100
Change from Baseline in CST Over Time
Time Frame: From Baseline to Week 100
From Baseline to Week 100
Percentage of Participants on Different Treatment Intervals at Weeks 52 and 100
Time Frame: Weeks 52 and 100
Weeks 52 and 100
Incidence and Severity of Ocular Adverse Events
Time Frame: From first study treatment to Week 100
From first study treatment to Week 100
Incidence and Severity of Non-Ocular Adverse Events
Time Frame: From first study treatment to Week 100
From first study treatment to Week 100

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2025

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

September 16, 2027

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

January 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR45638
  • 2024-517545-13-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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