What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for neovascular age-related macular degeneration (nAMD) such as Faricimab, Ranibizumab, Aflibercept, and Bevacizumab, which are administered via intravitreal injection, can have several side effects. These include eye pain, increased intraocular pressure, vitreous floaters, and inflammation inside the eye (endophthalmitis). Less commonly, patients may experience retinal detachment or hemorrhage. It is important for patients to discuss these potential side effects with their healthcare provider to make an informed decision about their treatment.

What prior FDA approvals exist?

The FDA has approved several intravitreal injections for the treatment of neovascular Age-Related Macular Degeneration (nAMD). These include anti-VEGF (vascular endothelial growth factor) therapies such as Ranibizumab (Lucentis), Aflibercept (Eylea), and Bevacizumab (Avastin, though used off-label). These treatments work by inhibiting the growth of abnormal blood vessels in the retina and reducing fluid leakage. Faricimab, currently being studied, also falls into this category of intravitreal injections aimed at managing nAMD by targeting both VEGF and Ang-2 pathways to provide a more comprehensive approach to treatment.

What other types of research exist?

Promising novel alternatives to Faricimab for nAMD patients include: 1) Brolucizumab, an anti-VEGF therapy that has shown efficacy in reducing fluid and improving vision with less frequent dosing. 2) Abicipar pegol, another anti-VEGF agent with a longer duration of action, potentially reducing the treatment burden. 3) Gene therapy approaches, such as RGX-314, which aim to provide sustained anti-VEGF expression with a single administration. 4) Port delivery systems like the ranibizumab port delivery system, which allows for continuous drug delivery and reduces the frequency of intravitreal injections.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 1 year

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 2023 Phase 3 trial • 1479 Patients • NCT04432831

13%

COVID-19

11%

Cataract

Hypertension

Diabetic retinal oedema

Nasopharyngitis

Conjunctival haemorrhage

Vitreous floaters

Diabetic retinopathy

Vitreous detachment

Urinary tract infection

Intraocular pressure increased

Posterior capsule opacification

Myocardial infarction

Acute kidney injury

Osteomyelitis

Pneumonia

Localised infection

Skin ulcer

Death

Cardiac failure congestive

Coronary artery disease

Cellulitis

Sepsis

Cerebrovascular accident

Renal failure

COVID-19 pneumonia

Vitreous haemorrhage

100%

80%

60%

40%

20%

Study treatment Arm

Faricimab PTI (Prior Faricimab Q8W)

Faricimab PTI (Prior Aflibercept Q8W)

Faricimab PTI (Prior Faricimab PTI)

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

0 / 1Eligibility criteria met

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.