Neovascular Age-related Macular Degeneration (nAMD)Phase 4CONSTANCENCT06795048
A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
A Phase 4 study testing Faricimab in people with Neovascular Age-related Macular Degeneration (nAMD), run by Hoffmann-La Roche at 67 sites in 12 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration (nAMD)
- What is being tested?
- Faricimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 67 sitesin 12 countries
- Study dates
- 14 Mar 2025to 20 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
67 sites in 12 countries.
67 sites in 12 countries
United States11 sites
Vision Research Center at Eye Associates of New Mexico
Albuquerque, New Mexico, 87109
Retinal Vitreal Consultants
Chicago, Illinois, 60616
Charles Retina Institute
Germantown, Tennessee, 38138
University Retina and Macula Associates, PC
Lemont, Illinois, 60439
Florida Retina Institute
Orlando, Florida, 32806-1101
Orange County Retina Medical Group
Santa Ana, California, 92705
Retina Consultants of Texas
Schertz, Texas, 78154
Sierra Eye Associates
Sparks, Nevada, 89434
New England Retina Consultants
Springfield, Massachusetts, 01107
Retina Associates of New Jersey
Teaneck, New Jersey, 07666
Ctr for Retina & Macular Dis
Winter Haven, Florida, 33880
Australia6 sites
Adelaide Eye and Retina Centre
Adelaide, South Australia, 5000
Centre For Eye Research Australia
East Melbourne, Victoria, 3002
The Lions Eye Institute
Nedlands, Western Australia, 6009
Retina Specialists Victoria
Rowville, Victoria, 3178
Strathfield Retina Clinic
Strathfield, New South Wales, 2135
Sydney Eye Hospital
Sydney, New South Wales, 2000
China6 sites
Peking University People's Hospital
Beijing, 100044
West China Hospital of Sichuan University
Chengdu, 610041
Sichuan Provincial People's Hospital
Chengdu, 610072
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, 510060
Eye and ENT hospital, Fudan University
Shanghai
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, 430030
France6 sites
Centre Retine Gallien
Bordeaux, 33000
Hopital Edouard Herriot - CHU Lyon
Lyon, 69437
Centre Ophtalmologique de L'Odeon
Paris, 75006
Hopital Lariboisiere
Paris, 75010
Centres Ophtalmologique St Exupéry
Saint-Cyr-sur-Loire, 37540
Clinique de l'Union
Saint-Jean, 31240
Italy6 sites
Azienda ospedaliero universitaria Policlinico Riuniti di Foggia;SC Oculistica
Foggia, Apulia, 71122
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Ospedale San Giuseppe
Milan, Lombardy, 20123
Azienda Ospedaliera Universitaria "Luigi Vanvitelli";UOC Oculistica
Napoli, Sicily, 80138
Azienda ospedaliero - universitaria Sant'Andrea;UOC Oculistica
Rome, Lazio, 00189
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette - Ancona, The Marches, 60126
South Korea6 sites
Pusan National University Hospital
Busan, 49241
Yeungnam University Medical Center
Daegu, 42415
Seoul National University Bundang Hospital
Seongnam-si, 13620
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
United Kingdom6 sites
Cardiff and Vale University Health Board
Cardiff, CF14 4XW
St James University Hospital
Leeds, LS9 7TF
Liverpool University Hospitals NHS Foundation Trust
Liverpool, L7 8XP
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
NewcastleUniversity& The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP
New Cross Hospital
Wolverhampton, WV10 0QP
Canada5 sites
St. Joseph's Health Care
London, Ontario, N6A 4V2
Retina Institute of Ottawa
Ottawa, Ontario, K2B 7E9
Hopital du Saint Sacrement
Québec, Quebec, G1S 4L8
Toronto Retina Institute
Toronto, Ontario, M3C 0G9
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Germany5 sites
Augenzentrum Prof. Koch GmbH
Frankfurt, 60549
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover, 30625
Augenzentrum am St Franziskus-Hospital
Münster
Universitatsklinikum Ulm, Augenklinik und Poliklinik
Ulm, 89075
Universitätsklinikum Würzburg, Augenklinik und Poliklinik
Würzburg, 97080
Spain5 sites
Oftalvist
Burjassot, Valencia(España), Valencia, 46100
Clinica Baviera
Madrid, 28046
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital General de Catalunya
Sant Cugat de Valles, Barcelona, 08190
Hospital Universitario Virgen del Rocio
Seville, 41013
Taiwan3 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
China Medical University Hospital
Taichung, 404332
National Taiwan University Hospital
Zhongzheng Dist., 10002
Singapore2 sites
Singapore Eye Research Institute
Singapore, 168751
Tan Tock Seng Hospital
Singapore, 308433
About this study
Official title: 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.
- Being tested
- Faricimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FaricimabDrug
Also called RO6867461, VABYSMO®
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Faricimab Early Treat & Extend Regimen | Experimental | Not described Receives: Drug: Faricimab |
| Arm B: Faricimab Modified Treat & Extend Regimen | Experimental | Not described Receives: Drug: Faricimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Best-Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 44, 48, and 52
Measured: 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
Measured: Baseline and average of Weeks 92, 96, and 100
Change from Baseline in BCVA Score Over Time
Measured: From Baseline to Week 100
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time
Measured: From Baseline to Week 100
Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time
Measured: From Baseline to Week 100
Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time
Measured: From Baseline to Week 100
Change from Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44, 48, and 52
Measured: Baseline and average of Weeks 44, 48, and 52
Change from Baseline in CST Averaged Over Weeks 92, 96, and 100
Measured: Baseline and average of Weeks 92, 96, and 100
Change from Baseline in CST Over Time
Measured: From Baseline to Week 100
Percentage of Participants on Different Treatment Intervals at Weeks 52 and 100
Measured: Weeks 52 and 100
Incidence and Severity of Ocular Adverse Events
Measured: From first study treatment to Week 100
Incidence and Severity of Non-Ocular Adverse Events
Measured: From first study treatment to Week 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start14 Mar 2025
- Primary completion16 Oct 2026
- Study completion20 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular Degeneration (nAMD)Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795048
- Sponsor's protocol ID
- MR45638
- Other IDs
- 2024-517545-13-00
- Acronym
- CONSTANCE
- Status last verified
- Oct 2026
- First submitted
- 24 Jan 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06795048
- Acronym / sponsor ID
- CONSTANCE / MR45638
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 16 Oct 2026 (actual)
- Study completion
- 20 Sep 2027 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Faricimab Early Treat & Extend Regimen | Experimental | Drug: Faricimab |
| Arm B: Faricimab Modified Treat & Extend Regimen | Experimental | Drug: Faricimab |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FaricimabAlso: RO6867461, VABYSMO®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. | Drug | Arm A: Faricimab Early Treat & Extend Regimen, Arm B: Faricimab Modified Treat & Extend Regimen |
Primary outcome
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
11 secondary outcomes
Change from Baseline in BCVA Score Averaged Over Weeks 92, 96, and 100
Time frame: Baseline and average of Weeks 92, 96, and 100
Change from Baseline in BCVA Score Over Time
Time frame: 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
Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time
Time frame: 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
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
Change from Baseline in CST Averaged Over Weeks 92, 96, and 100
Time frame: Baseline and average of Weeks 92, 96, and 100
Change from Baseline in CST Over Time
Time frame: From Baseline to Week 100
Percentage of Participants on Different Treatment Intervals at Weeks 52 and 100
Time frame: Weeks 52 and 100
Incidence and Severity of Ocular Adverse Events
Time frame: From first study treatment to Week 100
Incidence and Severity of Non-Ocular Adverse Events
Time frame: From first study treatment to Week 100
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
67 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Faricimab in people with Neovascular Age-related Macular Degeneration (nAMD), run by Hoffmann-La Roche at 67 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Australia, China, France, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.