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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Graz	Graz	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	04.07.2023

Trial locations

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.

Investigated diseases:

Neovascular age-related macular degeneration

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.

Trial ID:

2024-515377-10-00

NCT ID:

NCT05941715

Trial Phase:

Human Pharmacology (Phase I) – Other

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