Study on Aflibercept for Adults with Diabetic Macular Edema or Wet Age-Related Macular Degeneration

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What is this study about?

This clinical trial is focused on studying two eye conditions: diabetic macular edema and neovascular age-related macular degeneration. These conditions can cause vision problems due to fluid buildup in the eye. The treatment being tested is a medication called aflibercept, which is given as an injection into the eye. Aflibercept is also known by the code name BAY 86-5321. The purpose of the study is to understand how the body processes this medication when it is injected in both eyes at a higher dose than usual.

Participants in the study will receive injections of aflibercept in both eyes. The study will monitor the levels of the medication in the blood to see how it is absorbed and processed by the body. This will help researchers understand the effects of the medication when used in higher doses. The study will also include a comparison with a placebo to evaluate the effectiveness of the treatment.

The study will take place over a period of time, during which participants will receive regular injections and have their blood levels checked. This will help determine the maximum concentration of aflibercept in the blood. The information gathered from this study will contribute to understanding the safety and effectiveness of using high-dose aflibercept for treating these eye conditions.

1 initial treatment

Receive an injection of aflibercept (8 mg) in both eyes. This medication is administered as a solution for injection directly into the eye, a method known as intravitreal use.

The purpose of this step is to begin treatment for conditions such as diabetic macular edema or neovascular age-related macular degeneration.

2 monitoring and follow-up

Undergo regular monitoring to evaluate the levels of aflibercept in the bloodstream. This involves periodic blood tests to measure the concentration of the medication.

The primary goal is to assess the maximum observed concentration of free aflibercept in the body.

3 subsequent treatments

Receive additional injections of aflibercept as determined by the study protocol. The frequency and duration of these treatments will be based on the study’s requirements and the patient’s response to the initial treatment.

Continue to follow the prescribed schedule for injections and monitoring to ensure the effectiveness and safety of the treatment.

4 completion of study

The study is expected to conclude by February 27, 2026. Until this date, continue to participate in all required treatments and assessments.

After the final treatment and monitoring session, follow any additional instructions provided by the study team to ensure proper care and follow-up.

Who Can Join the Study?

Men or women who are 18 years or older can participate. If the legal age of adulthood in the country is more than 18 years, participants must meet that age requirement.
Participants can be either new to treatment or have been treated before. They must need intravitreal anti-Vascular endothelial growth factor (VEGF) treatment in both eyes, as determined by the study doctor. This treatment involves injections into the eye to help with certain eye conditions.
Participants with type 1 or type 2 diabetes and Diabetic Macular Edema (DME) in both eyes can join if at least one eye has active central involvement. This means there is swelling in the central part of the retina, which is the light-sensitive layer at the back of the eye. The Central Retinal Thickness (CRT) must be 300 micrometers or more, or 320 micrometers or more if measured with a specific device called Spectralis.
Participants with Neovascular Age-related Macular Degeneration (nAMD) in both eyes can join if at least one eye has active subfoveal Choroidal Neovascularization (CNV). This means there is abnormal blood vessel growth under the central part of the retina. There must also be intraretinal fluid (IRF) or subretinal fluid (SRF), which are types of fluid buildup in the retina, as seen on an eye scan called OCT.
Participants must have a Best Corrected Visual Acuity (BCVA) score between 78 and 24 on the Early Treatment Diabetic Retinopathy Study (ETDRS) letter chart. This is roughly equivalent to seeing between 20/32 and 20/320 on a standard eye chart. The reduced vision should mainly be due to DME or nAMD.
Female participants must not be pregnant or breastfeeding. Women who can have children and men who are sexually active with women who can have children must agree to use highly effective birth control methods. This should start before the first treatment, continue during the study, and last for at least 4 months after the last study treatment.

Who Cannot Join the Study?

Patients with any other eye diseases that could affect the study results.
Patients who have had eye surgery within the last three months.
Patients with a history of severe allergic reactions to similar medications.
Patients who are currently participating in another clinical trial.
Patients with uncontrolled high blood pressure.
Patients with a history of heart attack or stroke within the last six months.
Patients who are pregnant or breastfeeding.
Patients with any serious medical condition that could interfere with the study.
Patients who are unable to follow the study procedures or attend all study visits.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
University Hospital Bratislava	Bratislava	Slovakia
University Of Debrecen	Debrecen	Hungary
Bajcsy-Zsilinszky Korhaz Es Rendelointezet	Budapest	Hungary
Semmelweis University	Budapest	Hungary
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Fakultna Nemocnica S Poliklinikou Zilina	Zilina	Slovakia
Budapest Retina Associates	Budapest	Hungary
Axwj Cvedmuuh sejmal	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.09.2024
Hungary	Not recruiting	01.09.2024
Slovakia	Not recruiting	01.09.2024

Trial locations

Investigated drugs:

Aflibercept

Aflibercept is a medication used in this clinical trial to treat adults with diabetic macular edema or neovascular age-related macular degeneration. It is administered directly into the eye to help reduce swelling and improve vision by blocking the growth of abnormal blood vessels. The trial aims to study how the body processes this medication when given in a high dose.

Investigated diseases:

Neovascular age-related macular degeneration

Neovascular age-related macular degeneration (nAMD) – 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, distorting vision. Over time, this can result in a loss of central vision, making it difficult to see fine details. The progression of nAMD can vary, with some individuals experiencing rapid changes in vision.

Diabetic macular edema (DME) – This condition is a complication of diabetes that affects the eyes, specifically the macula. It occurs when high blood sugar levels damage the blood vessels in the retina, causing them to leak fluid into the macula. This leakage leads to swelling and thickening of the macula, which can distort vision. DME can develop at any stage of diabetic retinopathy and may progress slowly or quickly. The condition can cause blurred or wavy vision, making it challenging to read or recognize faces.

Trial ID:

2024-511665-11-00

Protocol code:

22578

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Aflibercept for Adults with Diabetic Macular Edema or Wet Age-Related Macular Degeneration

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