Not recruiting

Study Comparing Bevacizumab and Aflibercept for Patients with Wet Age-related Macular Degeneration

Registered 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 (wet) age-related macular degeneration, often referred to as wet AMD. This is a common eye disease that can lead to vision loss in older adults. The study is comparing two treatments: bevacizumab and aflibercept. Bevacizumab is known by the brand name Avastin, and it is given as a solution for infusion. Aflibercept, known as Eylea, is provided as a solution for injection. Both medications are administered through a method called intravitreal use, which means they are injected directly into the eye.

The purpose of this study is to determine if there is a difference in the number of injections needed over two years for patients treated with either bevacizumab or aflibercept for wet AMD. Participants in the study will receive one of these treatments, or a placebo, and will be monitored over a period of two years. During this time, the study will track how many injections are required, as well as other factors like visual acuity, which is the clarity or sharpness of vision, and the thickness of the macula, which is the central part of the retina responsible for detailed vision.

Additional aspects being observed include intraocular pressure, which is the fluid pressure inside the eye, and the interval between treatment sessions. The study will also assess the cost-effectiveness of the treatments by measuring quality-adjusted life years, a way to evaluate the value of medical interventions. Participants' vision-related quality of life will be evaluated using a questionnaire. The study aims to provide valuable insights into the effectiveness and efficiency of these treatments for wet AMD.

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
Joining the study
Upon joining the study, you will be required to provide a signed informed consent. This document confirms your understanding and agreement to participate in the trial.
You must be at least 50 years old and have been diagnosed with neovascular (wet) age-related macular degeneration.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes checking your distance visual acuity to ensure it is at least 34 on the ETDRS scale.
Diagnostic tests such as OCT-A and possibly FA/ICG will be performed to evaluate your condition.
Step 3
Randomization and treatment assignment
You will be randomly assigned to receive one of two treatments: bevacizumab or aflibercept. This process is double-blind, meaning neither you nor the study staff will know which treatment you are receiving.
Step 4
Treatment administration
The treatment involves intravitreal injections, which means the medication is injected directly into the eye.
If you are assigned to bevacizumab, you will receive Avastin 25 mg/ml as a solution for infusion. If assigned to aflibercept, you will receive Eylea 40 mg/mL as a solution for injection.
Step 5
Follow-up visits
Regular follow-up visits will be scheduled to monitor your progress and the effects of the treatment.
During these visits, assessments will be made on your best-corrected visual acuity, macular thickness, and intraocular pressure.
Step 6
End of study evaluation
At the end of the study, a final evaluation will be conducted to assess the number of injections received and the overall effectiveness of the treatment.
Additional assessments may include the recurrence interval, durability of the treatment effect, and a cost-benefit analysis.

Who can join the trial?

4 criteria

Signed informed consent: You must agree to participate in the study by signing a document that explains the study and your role in it.
Age: You must be 50 years or older, and this applies to all genders.
Diagnosis: You must have been diagnosed with the neovascular (wet) form of age-related macular degeneration. This is confirmed through specific eye tests called OCT-A, and if needed, FA/ICG, which are part of the usual clinical procedures.
Vision requirement: Your distance visual acuity, which is a measure of how well you can see at a distance, must be 34 or higher on the eye being studied. This is measured using a specific scale called ETDRS.

Who cannot join the trial?

9 criteria

Patients who have any other eye diseases that could affect the study results.
Patients who have had eye surgery in the last three months.
Patients who are currently participating in another clinical trial.
Patients who have allergies to the study medications.
Patients who are pregnant or breastfeeding.
Patients with uncontrolled high blood pressure.
Patients with a history of stroke or heart attack in the last six months.
Patients with severe kidney or liver disease.
Patients with any condition that the study doctor believes would make participation unsafe.

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Investigated drugs

Bevacizumab
is a medication used in this clinical trial to treat a condition called neovascular age-related macular degeneration, which affects the eyes. This condition can lead to vision loss, and bevacizumab works by blocking a protein in the body that can cause abnormal blood vessels to grow in the eye. By stopping this growth, bevacizumab helps to prevent further damage to the eyes and can help maintain vision.
Aflibercept
is another medication being tested in the trial for the same eye condition, neovascular age-related macular degeneration. Like bevacizumab, aflibercept also targets the protein responsible for the growth of abnormal blood vessels in the eye. By inhibiting this protein, aflibercept aims to reduce the progression of the disease and help preserve vision in patients.

What is already known about the treatment

Bevacizumab
Bevacizumab is administered through an injection directly into the eye, a method known as intravitreal injection. It is currently used in medicine to treat neovascular (wet) age-related macular degeneration (AMD), a condition that affects vision. The medication works by blocking a protein called VEGF, which is responsible for the growth of abnormal blood vessels in the eye. Bevacizumab is classified as an anti-VEGF agent, which helps to slow down or stop the progression of vision loss in patients with this condition.
Aflibercept
Aflibercept is also given as an intravitreal injection, meaning it is injected directly into the eye. It is used in the treatment of neovascular (wet) age-related macular degeneration (AMD), a disease that can lead to severe vision loss. Aflibercept acts by trapping the VEGF protein, preventing it from causing the growth of harmful blood vessels in the eye. This medication is part of the anti-VEGF class, which is designed to help maintain vision and prevent further deterioration in patients with AMD.

Investigated diseases

Neovascular (wet) age-related macular degeneration (AMD) – This disease is a chronic eye disorder that causes blurred vision or a blind spot in the visual field. 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, the part of the eye responsible for central vision. As the disease progresses, it can lead to rapid and severe vision loss. The condition is characterized by the formation of new, fragile blood vessels, a process known as neovascularization. Over time, the damage to the macula can become more pronounced, affecting the ability to see fine details.