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Monoclonal Antibodies

Faricimab for Age-Related Macular Degeneration (AVONELLE-X Trial)

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Requirement for continuous use of any medications or treatments indicated as prohibited therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 1 year
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing the long-term safety of injecting faricimab into the eyes of patients with a specific eye condition called nAMD. These patients have already participated in earlier studies. The drug works by stopping abnormal blood vessel growth in the eye to help prevent vision loss. Faricimab has shown positive results in multiple studies for treating eye diseases.

Who is the study for?
This trial is for adults with neovascular age-related macular degeneration who completed previous Phase III studies (GR40306 or GR40844) without dropping out. Women must use effective contraception and not donate eggs during the study. People can't join if they're pregnant, breastfeeding, plan to become pregnant soon, have other eye diseases or conditions that make faricimab unsafe for them, or are allergic to its components.
What is being tested?
The trial tests the long-term safety of Faricimab given by injection into the eye at personalized intervals to treat nAMD. A substudy also compares treated eyes with untreated fellow eyes to assess corneal health as required by the FDA.
What are the potential side effects?
While specific side effects aren't listed here, common ones from similar treatments include eye irritation or discomfort after injection, increased risk of eye infection, possible allergic reactions, and potential impact on vision.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not on any medications that are not allowed in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at 1 Year in the Study Eye as Compared With the Fellow Eye
Secondary study objectives
Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye

Side effects data

From 2021 Phase 3 trial • 940 Patients • NCT03622580
19%
Cataract
9%
Nasopharyngitis
8%
Conjunctival haemorrhage
7%
Hypertension
6%
Diabetic retinal oedema
6%
Vitreous detachment
5%
Vitreous floaters
5%
Fall
5%
Intraocular pressure increased
4%
Urinary tract infection
3%
Pneumonia
2%
Acute myocardial infarction
2%
Cardiac failure congestive
2%
Sepsis
2%
Renal failure
2%
COVID-19
1%
Acute kidney injury
1%
Cardiac arrest
1%
Chronic kidney disease
1%
Atrial fibrillation
1%
End stage renal disease
1%
Vitreous haemorrhage
1%
Coronary artery disease
1%
Myocardial infarction
1%
Myocardial ischaemia
1%
Diabetic retinopathy
1%
Glaucoma
1%
Chest pain
1%
Death
1%
Cellulitis
1%
Osteomyelitis
1%
Diabetes mellitus
1%
Hyperglycaemia
1%
Hyperkalaemia
1%
Cerebral infarction
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Syncope
1%
Acute respiratory failure
1%
Pleural effusion
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
A: Faricimab 6 mg Q8W
B: Faricimab 6 mg PTI
C: Aflibercept 2 mg Q8W

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Substudy: Faricimab PTIExperimental Treatment1 Intervention
Group II: Main Study: Faricimab PTIExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Faricimab
2023
Completed Phase 3
~7760

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Age-Related Macular Degeneration, particularly neovascular AMD (nAMD), involve anti-VEGF (vascular endothelial growth factor) therapies. These treatments, including Faricimab, work by inhibiting the activity of VEGF, a protein that promotes the growth of abnormal blood vessels under the retina. By blocking VEGF, these therapies reduce the formation of these leaky blood vessels, thereby decreasing fluid accumulation and preventing further damage to the retinal tissue. This mechanism is crucial for AMD patients as it helps to stabilize vision, reduce the risk of severe vision loss, and improve overall visual outcomes.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,450 Previous Clinical Trials
1,094,447 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,220 Previous Clinical Trials
894,354 Total Patients Enrolled

Media Library

Faricimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04777201 — Phase 3
Age-Related Macular Degeneration Research Study Groups: Main Study: Faricimab PTI, Substudy: Faricimab PTI
Age-Related Macular Degeneration Clinical Trial 2023: Faricimab Highlights & Side Effects. Trial Name: NCT04777201 — Phase 3
Faricimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04777201 — Phase 3
~230 spots leftby Oct 2025