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Study on Faricimab and Aflibercept for Patients with Neovascular Age-Related Macular Degeneration Receiving Frequent Aflibercept Treatment

Verified siteRegistered drugNo placebo

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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 (nAMD), which is a common eye disease that can lead to vision loss in older adults. The study is comparing two treatments: Faricimab, also known by its code name RO6867461, and Aflibercept, which is marketed as Eylea. Both treatments are solutions for injection that are administered directly into the eye to help manage this condition.

The purpose of the study is to evaluate how effective Faricimab is compared to Aflibercept in terms of how long the treatment effects last. Participants in the study will receive either Faricimab or Aflibercept and will be monitored over a period of time to see how well their condition is managed. The study will look at how often the treatments need to be given and how well they work in reducing fluid in the eye, which is a common issue in nAMD.

Throughout the study, participants will have regular check-ups to monitor their eye health and the effectiveness of the treatment. The study aims to find out if Faricimab can extend the time between treatments compared to Aflibercept, potentially offering a more convenient treatment option for those with nAMD. The trial will last for a total of 56 weeks, with key assessments at 32 weeks and 56 weeks to determine the success of the treatment in managing the disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must provide a signed written informed consent.
The patient must be at least 50 years old and have a specific eye condition known as neovascular age-related macular degeneration (nAMD).
The patient must have received at least seven previous injections in the eye with anti-VEGF medication, with the last four injections being aflibercept, administered within the last 35 days.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate the patient's vision using a test that measures the ability to read letters on a chart.
The patient's eye condition will be assessed to ensure there is no fluid in the retina.
Step 3
Treatment phase
The patient will receive injections of either faricimab or aflibercept into the eye. These are solutions for injection administered through a procedure called intravitreal use, which involves injecting the medication directly into the eye.
The goal is to extend the interval between treatments while maintaining the absence of retinal fluid.
Step 4
Monitoring and follow-up
The patient's eye condition will be monitored regularly to assess the presence of retinal fluid and the effectiveness of the treatment.
The study aims to evaluate the proportion of eyes that can extend the treatment interval without retinal fluid over a period of 32 weeks and further up to 56 weeks.
Step 5
Final assessment
At the end of the study period, a final assessment will be conducted to evaluate the overall effectiveness of the treatment.
The study will measure changes in vision and the number of injections received during the study period.

Who can join the trial?

9 criteria

You must provide a signed written informed consent, which means you agree to participate in the study after understanding all the details.
You should be willing and able to attend clinic visits and follow the procedures related to the study.
You need to be **50 years of age or older**.
You must have **MNV due to AMD (nAMD)**, which stands for a type of eye condition called neovascular age-related macular degeneration.
Your **BVCA** (Best Corrected Visual Acuity) should be between 19 and 75 letters, which is roughly equivalent to a vision range from 20/400 to 20/32 on the Snellen chart.
You should have received **7 or more previous intravitreal injections** with anti-VEGF, which are treatments injected into the eye to help with your condition.
The last **4 or more consecutive injections** should have been with a medication called **aflibercept**.
Your last aflibercept injection should have been within the last **35 days**.
The time between your last two aflibercept injections should be **35 days or less**.

Who cannot join the trial?

7 criteria

Patients with any other eye disease that could affect the study results.
Patients who have had eye surgery within the last 3 months.
Patients with uncontrolled high blood pressure.
Patients with a history of stroke or heart attack in the last 6 months.
Patients who are pregnant or breastfeeding.
Patients with an allergy to any of the study medications.
Patients who are participating in another clinical trial.

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Verified sites

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Medical University Of Graz
Graz, Austria

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Investigated drugs

Faricimab
is a medication being studied for its effectiveness in treating neovascular age-related macular degeneration, a condition that affects the eyes and can lead to vision loss. The trial aims to see if faricimab can extend the time between treatments compared to another medication, potentially reducing the frequency of injections needed by patients.
Aflibercept
is another medication used in the trial as a comparison to faricimab. It is currently used to treat neovascular age-related macular degeneration by helping to slow down vision loss. The study is comparing how long the effects of aflibercept last in patients who have been receiving frequent treatments.

What is already known about the treatment

Faricimab
Faricimab is administered through an injection directly into the eye. It is currently being studied in clinical trials for its effectiveness in treating neovascular age-related macular degeneration, a condition that affects vision. The medication works by targeting and inhibiting specific proteins that contribute to abnormal blood vessel growth in the eye. Faricimab is classified as an anti-VEGF and anti-angiopoietin therapy, aiming to improve the durability of treatment effects compared to existing therapies.
Aflibercept
Aflibercept is also administered via an injection into the eye. It is an established treatment for neovascular age-related macular degeneration, helping to slow the progression of vision loss. The drug functions by blocking proteins that promote the growth of abnormal blood vessels in the eye. Aflibercept is classified as an anti-VEGF therapy and is widely used in clinical practice for managing this eye condition.

Investigated diseases

Neovascular age-related macular degeneration – This is a chronic eye condition that affects the macula, the central part of the retina responsible for sharp vision. It occurs when abnormal blood vessels grow under the retina and macula, leading to leakage of blood and fluid. This leakage can cause damage to the macula, resulting in vision loss or distortion. The disease often progresses with the formation of scar tissue, which can further impair vision. It is more common in older adults and can significantly affect the ability to perform everyday tasks like reading and recognizing faces. The progression of the disease can vary, with some individuals experiencing rapid changes in vision.