Not recruiting

Study of Aflibercept 8mg for Patients with Neovascular Age-Related Macular Degeneration Previously Treated with Faricimab and Aflibercept 2mg

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 will use a treatment called aflibercept, which is given as an injection into the eye. Aflibercept is designed to help manage this eye condition by reducing abnormal blood vessel growth and fluid in the eye, which can help maintain vision.

The purpose of the study is to evaluate how well an 8 mg dose of aflibercept works over a period of 32 weeks in patients who have previously been treated with another medication called faricimab and a lower dose of aflibercept (2 mg). The study will observe if the treatment can be extended over time without the return of fluid in the eye, which is a sign of the disease's activity. Participants will receive regular injections and attend clinic visits to monitor their eye health and the effectiveness of the treatment.

Throughout the study, the main focus will be on the ability of aflibercept to maintain eye health by extending the time between treatments while keeping the eye free of fluid. The study will also track the number of injections needed and any changes in vision. This research aims to provide valuable information on the potential benefits of using a higher dose of aflibercept for managing neovascular age-related macular degeneration.

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
Participation in the study requires prior involvement in the FAN study and signing a written informed consent.
Participants must be at least 50 years old and have a specific eye condition known as neovascular age-related macular degeneration (nAMD).
Step 2
Initial assessment
An initial assessment will be conducted to evaluate the condition of the eyes, including the presence of retinal fluid and visual acuity measured in letters.
Step 3
Treatment administration
The treatment involves the administration of aflibercept 8mg through an injection into the eye (intravitreal use).
The goal is to extend the interval between treatments while maintaining eye health.
Step 4
Monitoring and follow-up
Regular follow-up visits will be scheduled to monitor the eye condition and adjust treatment intervals as needed.
The study aims to assess the effectiveness of the treatment over a period of 32 weeks.
Step 5
Final evaluation
At the end of the 32-week period, a final evaluation will be conducted to determine the success of the treatment in terms of reducing retinal fluid and improving or maintaining vision.

Who can join the trial?

9 criteria

Must have participated in the FAN study before.
Must sign a written informed consent, which means agreeing to participate after understanding the study details.
Must be willing and able to attend clinic visits and follow study-related procedures.
Must be **50 years of age or older**.
Must have **MNV due to AMD (nAMD)**, which means abnormal blood vessel growth in the eye due to age-related macular degeneration.
Must have a **BVCA** (Best Corrected Visual Acuity) between 19 and 75 letters, which is similar to a vision range of about 20/400 to 20/32 on a standard eye chart.
Must have received **4 or more previous injections** into the eye with a medication called faricimab.
Must have eyes that are on a treatment schedule of **35 days or less**.
Must not have met the criteria for extending the treatment interval with faricimab, meaning there was still fluid in the retina or under the retina at 6 weeks.

Who cannot join the trial?

8 criteria

Patients who have any other eye diseases that could affect the study results.
Patients who have had eye surgery within the last three months.
Patients who have uncontrolled high blood pressure.
Patients who have a history of stroke or heart attack within the last six months.
Patients who are pregnant or breastfeeding.
Patients who have an allergy to the study medication.
Patients who are participating in another clinical trial.
Patients who have any serious health conditions that the study doctor thinks could interfere with the study.

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Verified sites

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Medical University Of Graz
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Graz, Austria

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Investigated drugs

Aflibercept
This medication is used in the trial to treat neovascular age-related macular degeneration, a condition that affects the eyes. The study is testing a higher dose of 8mg to see if it can extend the time between treatments for patients who have previously been treated with a lower dose of 2mg. Aflibercept works by blocking the growth of abnormal blood vessels in the eye, which can help maintain vision.
Faricimab
This is another medication used to treat neovascular age-related macular degeneration. It has been used in patients who require frequent treatments. The trial is looking at how patients who have been treated with faricimab respond to the new dosing schedule of aflibercept. Faricimab helps to reduce fluid leakage and swelling in the eye, which can improve vision.

Aflibercept

What is already known about the treatment

Aflibercept – Aflibercept is administered as an injection directly into the eye. It is currently used in the treatment of neovascular age-related macular degeneration, a condition that affects vision. The medication works by inhibiting the action of vascular endothelial growth factor (VEGF), a protein that promotes the growth of abnormal blood vessels in the eye. By blocking VEGF, aflibercept helps reduce the leakage and growth of these blood vessels, thereby preserving vision. It is classified as an anti-VEGF agent in pharmacology.

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 the macula to lift and pull away from its base, resulting in rapid and severe vision loss. The disease typically progresses with symptoms such as blurred vision, dark spots in the center of vision, and distorted vision. Over time, it can lead to significant impairment of central vision, affecting daily activities like reading and recognizing faces. The progression can vary, with some individuals experiencing a slow decline in vision, while others may notice a rapid deterioration.