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Study on Treating Neovascular Age-Related Macular Degeneration with Aflibercept, Ranibizumab, and Brolucizumab for Patients with Active Disease

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What is this trial about?

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

This clinical trial focuses on the treatment of neovascular age-related macular degeneration (AMD), a condition that affects the eyes and can lead to vision loss. The study will use three different medications: Eylea (aflibercept), Lucentis (ranibizumab), and Beovu (brolucizumab). These medications are given as injections into the eye and are designed to help manage the disease by reducing the growth of abnormal blood vessels and fluid in the eye.

The purpose of the study is to explore how automated tools can help in assessing and treating patients with active neovascular AMD in a real-world setting. This approach aims to benefit both patients and the healthcare system by potentially reducing the number of visits and treatments needed. Participants in the study will receive one of the medications and will be monitored over a period of time to see how well the treatment works in managing their condition.

Throughout the study, various aspects of the eye's health will be assessed, including visual acuity, which is how well one can see, and changes in the structure of the eye, such as the thickness of the retina and the presence of fluid. The study will also look at the overall quality of life of participants, as well as any changes in the eye's blood flow and the formation of any new eye conditions. The study is expected to continue until 2025.

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 assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes checking for active neovascular age-related macular degeneration (AMD) and ensuring a best-corrected visual acuity score of at least 0.1 (20/200) in the study eye.
The assessment involves imaging tests such as optical coherence tomography (OCT), OCT angiography (OCTA), and fluorescein angiography (FA).
Step 2
Treatment initiation
Treatment begins with the administration of one of the following medications: Eylea (aflibercept) 40 mg/mL, Lucentis (ranibizumab) 10 mg/mL, or Beovu (brolucizumab) 120 mg/mL. These are solutions for injection.
The medication is injected into the eye to manage the condition.
Step 3
Regular follow-up visits
Regular follow-up visits are scheduled to monitor the condition and adjust treatment as necessary.
During these visits, the number of anti-VEGF injections is recorded, and visual acuity is assessed using the ETDRS score.
Step 4
Ongoing assessments
Ongoing assessments include checking for changes in the macula using OCT, such as central retinal thickness and fluid volumes.
Additional tests may include fundus photography to assess macular atrophy, OCT to check for retinal tears, and OCTA to evaluate chorioretinal perfusion.
Step 5
Quality of life evaluation
Quality of life is evaluated through questionnaires to understand the impact of the treatment on daily living.
This evaluation helps in understanding the overall benefits of the treatment from the patient's perspective.
Step 6
Study completion
The study is expected to conclude by August 28, 2025.
Final assessments will be conducted to evaluate the overall effectiveness of the treatment and any long-term changes in the condition.

Who can join the trial?

6 criteria

Adults who are **50 years or older**.
Have **active neovascular AMD**. This includes types like classic, occult choroidal neovascularization (CNV), RAP lesion, or PCV lesion. These conditions are checked using special eye tests called OCT, OCTA, and FA.
Have a **BCVA score** of **0.1 (20/200) or better** in the eye being studied. BCVA stands for Best Corrected Visual Acuity, which is a measure of how well you can see with glasses or contact lenses, using a special chart called ETDRS.
No significant **fibrosis** or **geographic atrophy (GA)** affecting the **fovea**. Fibrosis is a type of scar tissue, and geographic atrophy is a condition where parts of the retina waste away. The fovea is the part of the eye responsible for sharp central vision.
Willing and able to attend study visits and follow study procedures.
Have signed an **informed consent form**, which means you understand the study and agree to participate.

Who cannot join the trial?

3 criteria

Patients who do not have **neovascular AMD**. This is a condition affecting the eyes, specifically the part of the eye called the macula, which is responsible for sharp vision.
Patients who are not within the specified age range for the study. The study may have specific age requirements that participants must meet.
Patients who are part of a vulnerable population. This means groups of people who might need special protection or care, such as children or those with certain disabilities.

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Medical University Of Vienna
Vienna, Austria

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Investigated drugs

Aflibercept is a medication used in the treatment of neovascular age-related macular degeneration (nAMD). It works by inhibiting the growth of abnormal blood vessels in the eye, which can help reduce fluid leakage and swelling, ultimately preserving vision.

What is already known about the treatment

Ranibizumab – Ranibizumab is administered as an injection directly into the eye. It is currently well-established in medical literature and widely used in clinical practice. The main therapeutic indication for Ranibizumab is the treatment of neovascular age-related macular degeneration (AMD). At the molecular level, it works by inhibiting vascular endothelial growth factor A (VEGF-A), which reduces abnormal blood vessel growth and leakage in the eye. It is classified as an anti-VEGF agent.

Investigated diseases

Neovascular Age-related Macular Degeneration (AMD) – 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 from its normal position, resulting in rapid and severe vision loss. Over time, the condition can lead to the formation of scar tissue, further damaging the macula. The progression of neovascular AMD can vary, with some individuals experiencing a gradual decline in vision, while others may notice a sudden change. Regular monitoring and assessment of the condition are crucial to understanding its progression and impact on vision.