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Monoclonal Antibodies
Faricimab for Age-Related Macular Degeneration (CONSTANCE Trial)
Winter Haven, FL
Phase 4
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to study the effectiveness, safety, and lasting effects of a medication called faricimab in patients with a specific eye condition. The medication will be given directly into the eye at specific
Who is the study for?
This trial is for adults with a specific eye condition called neovascular age-related macular degeneration (nAMD) who haven't had previous treatments. They should be able to see at certain levels, have clear eyes for imaging, agree to follow contraception rules, and be generally healthy.
What is being tested?
The study tests Faricimab's effectiveness and safety in treating nAMD over 100 weeks. Participants will receive the drug through an injection into the eye at intervals that could extend up to 24 weeks.
What are the potential side effects?
Possible side effects of Faricimab include discomfort or pain in the eye where injected, increased risk of eye infection, potential inflammation inside the eye, and vision changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have untreated AMD-related vision loss with confirmed fluid in my retina.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My vision loss is not due to age-related macular degeneration.
Select...
I have a tear in the retina affecting my central vision.
Select...
My other eye does not work well or is missing.
Select...
I have received eye injections or drugs for other eye conditions.
Select...
I have had uveitis with no known cause or due to an autoimmune condition.
Select...
I do not have eye inflammation or infection as the study starts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2023 Phase 3 trial • 1479 Patients • NCT0443283110%
COVID-19
8%
Cataract
5%
Diabetic retinal oedema
4%
Posterior capsule opacification
4%
Hypertension
3%
Urinary tract infection
2%
Pneumonia
2%
Intraocular pressure increased
2%
Nasopharyngitis
2%
Diabetic retinopathy
2%
Vitreous detachment
2%
Conjunctival haemorrhage
1%
Acute myocardial infarction
1%
Cardiac failure congestive
1%
Myocardial infarction
1%
Cellulitis
1%
Chronic kidney disease
1%
Osteomyelitis
1%
Breast cancer
1%
Cerebrovascular accident
1%
Nephrolithiasis
1%
Diabetic foot
1%
Peripheral ischaemia
1%
Vitreous haemorrhage
1%
Vitreous floaters
1%
Death
1%
Acute kidney injury
1%
Cardiac failure
1%
Coronary artery disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Faricimab PTI (Prior Faricimab PTI)
Faricimab PTI (Prior Aflibercept Q8W)
Faricimab PTI (Prior Faricimab Q8W)
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: Faricimab Modified Treat & Extend RegimenExperimental Treatment1 Intervention
Group II: Arm A: Faricimab Early Treat & Extend RegimenExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Faricimab
2023
Completed Phase 3
~7760
Find a Location
Closest Location:Ctr for Retina & Macular Dis· Winter Haven, FL
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,481 Previous Clinical Trials
1,106,892 Total Patients Enrolled
28 Trials studying Macular Degeneration
18,230 Patients Enrolled for Macular Degeneration
Clinical TrialsStudy DirectorHoffmann-La Roche
2,257 Previous Clinical Trials
906,562 Total Patients Enrolled
36 Trials studying Macular Degeneration
19,957 Patients Enrolled for Macular Degeneration