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Study on Faricimab for Patients with Neovascular Age-Related Macular Degeneration Who Have Not Received Prior Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called neovascular age-related macular degeneration (AMD), which affects the eyes and can lead to vision loss. The study will use a treatment called Vabysmo, which is a solution for injection containing the active substance faricimab. Faricimab is a type of protein designed to help manage this eye condition by targeting specific factors involved in the disease process.

The purpose of the study is to investigate how effective two initial doses of faricimab are in reducing disease activity in patients who have not received treatment for neovascular AMD before. Participants will receive these doses through an injection into the eye, a method known as intravitreal use. The study will monitor the patients over a period to see if the disease becomes less active and to assess any changes in vision and eye health.

Throughout the study, researchers will evaluate the proportion of patients who show no signs of disease activity after eight weeks. They will also look at how often patients need further treatment after the initial doses and any changes in vision clarity and eye structure. This information will help determine the effectiveness of the treatment and provide insights into managing neovascular AMD more effectively.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will have an initial visit where your eligibility will be confirmed. This includes checking your age, confirming that you have not received treatment for neovascular age-related macular degeneration (nAMD) in the study eye, and ensuring the size of the affected area in your eye is appropriate.
Your best corrected visual acuity (BCVA) will be measured, and the study eye will be selected. This is the eye with the lower BCVA if both eyes are eligible. The diagnosis will be confirmed using special imaging techniques.
Step 2
First treatment
You will receive the first dose of the medication called faricimab. This is administered as an injection directly into the eye, a method known as intravitreal use.
The medication is provided as a solution with a concentration of 120 mg/mL.
Step 3
Second treatment
A second dose of faricimab will be administered. This is also an injection into the eye, similar to the first treatment.
The timing of this dose will be determined by the study protocol.
Step 4
Follow-up assessments
You will have follow-up visits to assess the effectiveness of the treatment. These assessments will occur at weeks 4 and 8 after the initial treatment.
During these visits, changes in your best corrected visual acuity (BCVA) and the thickness of the central part of your retina will be measured.
Step 5
Evaluation of disease activity
At week 8, the study will evaluate whether there is any disease activity. The goal is to determine the proportion of patients who do not show signs of active disease.
Additional measurements and imaging tests will be conducted to predict whether the disease is active or not.
Step 6
Treatment interval determination
Based on your response to the initial doses, the interval for the next treatment will be determined. This could range from 4 to 16 weeks after the second dose.
The study aims to find the most effective treatment schedule for maintaining disease control.

Who can join the trial?

7 criteria

Patients must be 50 years old or older on the first day of the study.
All patients must have neovascular age-related macular degeneration (nAMD) in the study eye and should not have received any treatment for it before.
The type of age-related macular degeneration (AMD) must be type 1 or type 2.
The size of the choroidal neovascularization lesion (an area of abnormal blood vessel growth) must be nine or fewer disc areas.
For each participant, one eye will be chosen as the study eye. If both eyes are eligible, the one with the lower BCVA (Best Corrected Visual Acuity, which is a measure of the best vision a person can achieve with glasses or contact lenses) during the screening will be selected.
The diagnosis must be confirmed with fluorescein and/or indocyanine green angiography (special imaging tests that use dye to look at blood vessels in the eye).
The BCVA should be between 78 and 24 ETDRS letters (a standardized way to measure visual acuity) on the first day of the study.

Who cannot join the trial?

9 criteria

Patients with any other eye diseases that could affect the study results cannot participate.
Patients who have had eye surgery within the last 3 months are not eligible.
Patients with uncontrolled high blood pressure cannot take part in the study.
Patients with a history of stroke or heart attack in the last 6 months are excluded.
Patients who are currently participating in another clinical trial are not allowed to join.
Patients with allergies to the study medication or similar drugs cannot participate.
Pregnant or breastfeeding women are not eligible for the study.
Patients with severe liver or kidney disease are excluded from the study.
Patients with any condition that the study doctors believe would make it unsafe for them to participate are not allowed to join.

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Medical University Of Graz
Graz, Austria

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Investigated drugs

Faricimab is a medication used in this clinical trial to treat a condition called neovascular age-related macular degeneration (AMD). This condition affects the eyes and can lead to vision loss. Faricimab works by blocking certain proteins that cause abnormal blood vessel growth in the eye, which can help reduce swelling and prevent further damage to the retina. In this trial, the researchers are studying how effective two initial doses of Faricimab are in making the disease inactive, meaning it stops progressing and causing harm to the patient's vision.

Faricimab

What is already known about the treatment

Faricimab – Faricimab is administered through an injection directly into the eye, a method used to treat certain eye conditions. It is currently being studied in clinical trials for its effectiveness in treating neovascular age-related macular degeneration (AMD), a condition that can lead to vision loss. The medication works by targeting and inhibiting specific proteins that contribute to the growth of abnormal blood vessels in the eye, which are responsible for the progression of this disease. Faricimab is classified as an anti-VEGF (vascular endothelial growth factor) and anti-ANG2 (angiopoietin-2) agent, which helps reduce inflammation and leakage in the eye, aiming to maintain or improve vision.

Investigated diseases

Neovascular age-related macular degeneration – This disease affects the central part of the retina, known as the macula, leading to vision loss. It is characterized by the growth of abnormal blood vessels beneath the retina. These vessels can leak fluid or blood, causing damage to the macula. As the disease progresses, it can lead to a gradual or sudden decrease in central vision. Patients may experience blurred or distorted vision, making it difficult to read or recognize faces. Over time, the central vision may become severely impaired, while peripheral vision usually remains unaffected.