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Study of two initial doses of aflibercept for patients with newly diagnosed neovascular age-related macular degeneration

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 study focuses on individuals with Neovascular age-related macular degeneration, a condition where abnormal blood vessels grow under the retina, which is the light-sensitive part of the eye at the back of the eye. These growing vessels can leak fluid or blood, potentially leading to vision loss. The research aims to investigate how effective two initial 8 mg doses of aflibercept, also known as Eylea, are in making the disease inactive. This medication is administered through an intravitreal injection, which means the medicine is injected directly into the fluid inside the eye.

Participants in the study will receive two initial high doses of the medication. Following these starting doses, the study will observe the effects on the eye over several weeks. This includes monitoring changes in visual acuity, which is the clarity or sharpness of vision, and checking for any fluid in the macula, the central part of the retina responsible for detailed vision. Specialized imaging such as optical coherence tomography, a non-invasive way to take cross-section pictures of the retina, may be used to look at the thickness of the retinal layers and the presence of fluid.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial doses

    You will receive two loading doses of aflibercept (8 mg). these are intravitreal injections, which means the medicine is injected directly into the eye to treat neovascular age-related macular degeneration (a condition where abnormal blood vessels grow under the retina and can cause vision loss).

    The loading doses are used to start the treatment quickly.

  2. Step 2

    Monitoring and assessment

    During the first 8 weeks, your eye condition will be monitored to see if the disease is non-active (meaning the abnormal blood vessel activity has stopped).

    Your visual acuity (the clarity of your vision) will be measured at week 4 and week 8.

    Specialized imaging, such as optical coherence tomography (a non-invasive scan that takes cross-section pictures of the retina) and angiography (imaging of the blood vessels), will be used to check the thickness of the retina and the amount of fluid in the eye.

  3. Step 3

    Follow-up treatment planning

    After the second loading dose, the time until the third injection will be observed. the interval between these doses may be 4, 6, 8, 10, 12, 14, or 16 weeks.

Who can join the trial?

7 criteria

  • You must be at least 50 years old at the start of the study.
  • The eye being studied must have neovascular age-related macular degeneration, which is a type of eye disease that affects central vision, and you must not have received any prior treatment for it in that eye.
  • Your condition must be categorized as type 1 or type 2.
  • The size of the choroidal neovascularization, which is an abnormal growth of blood vessels under the retina, must be nine or fewer disc areas (a measurement used to compare the size of the growth to the size of the optic nerve).
  • One eye will be selected for the study; if both eyes meet the requirements, the eye with the lower Best Corrected Visual Acuity (BCVA), which is the best level of vision you can achieve with glasses or contact lenses, will be chosen.
  • The diagnosis must be confirmed using fluorescein angiography or indocyanine green angiography, which are special imaging tests that use a colored dye to look at the blood vessels in the eye.
  • Your Best Corrected Visual Acuity (BCVA) must be between 24 and 78 ETDRS letters, which is a standardized way of measuring how many letters you can read on a vision chart.

Who cannot join the trial?

12 criteria

  • You cannot take part if you have participated in another clinical trial (a research study involving people) in the last 4 weeks.
  • You cannot participate if you have had cataract surgery (a procedure to remove a cloudy lens in the eye) within the last 3 months on the eye being studied, or if you have one scheduled during the study.
  • You cannot join if you have had any other intraocular surgery (surgery performed inside the eye) on the study eye, such as a vitrectomy (removing the gel that fills the eye), glaucoma surgery (to reduce eye pressure), or a corneal transplant (replacing the clear front part of the eye).
  • You are excluded if you have Polypoidal choroidal vasculopathy (PCV) or type 3 AMD, which are specific types of eye diseases confirmed by special imaging tests like fluorescein angiography or indocyanine green angiography (tests that use special dye to look at blood vessels in the eye).
  • You cannot participate if you are currently taking part in another research study at the same time.
  • You cannot join if you require any intraocular surgery (surgery inside the eye) on the study eye while the study is ongoing.
  • You are not eligible if you are pregnant or breast-feeding.
  • You cannot participate if you are currently undergoing chemotherapy (medicine used to treat cancer).
  • You are excluded if you have a known hypersensitivity (an allergic reaction) to aflibercept, which is the medication being tested.
  • You cannot join if you have other eye conditions affecting your vision or causing fluid under the retina, such as retinal detachment (when the retina pulls away from the back of the eye), diabetic maculopathy (eye damage caused by diabetes), an epiretinal membrane (a thin layer of tissue over the retina), or central serous chorioretinopathy (fluid buildup under the retina).
  • You are excluded if you have an RPE tear (a tear in the layer of tissue that supports the retina) that involves the macula (the center part of the retina responsible for detailed vision) on the day the study begins.
  • You cannot participate if you have more than 6 diopters of myopia (severe nearsightedness) in the study eye, or if your nearsightedness was greater than -6 diopters before a previous eye surgery.
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Investigated drugs

Aflibercept is a medication injected into the eye to help treat a specific type of vision loss. It works by blocking certain proteins in the body that cause abnormal blood vessel growth, which can damage the retina and affect eyesight.

What is already known about the treatment

Aflibercept - This medication is a liquid solution administered through a direct injection into the eye to treat wet age-related macular degeneration. It is an established treatment used to prevent vision loss by acting as a decoy that captures specific proteins, known as VEGF, which are responsible for growing abnormal and leaky blood vessels in the retina. By blocking these proteins at a molecular level, the drug helps stabilize or improve vision in patients with this eye condition. This substance is pharmacologically classified as an angiogenesis inhibitor.

Investigated diseases

Neovascular age-related macular degeneration - This eye condition occurs when abnormal blood vessels grow underneath the retina. These new vessels are fragile and can leak fluid or blood into the central part of the eye. As the condition progresses, the leaking fluid causes swelling in the macula, which is the area responsible for sharp, central vision. This swelling can lead to damage in the retinal tissue over time. The accumulation of fluid and blood can distort or blur the central field of vision.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523478-17-00Estimated enrolment50 patientsSponsorMedical University Of Graz

sourced from the EU Clinical Trials Register and site verification

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