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Randomized Study of Intravitreal mk-8748 Compared with Aflibercept in Patients with 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

The study involves people with neovascular age-related macular degeneration, a condition where abnormal blood vessels grow under the retina and can lead to loss of sharp central vision. Two medicines are being compared: an existing eye injection called aflibercept and a new investigational drug identified as MK-8748. Both are given as an intravitreal injection, meaning the medication is placed directly into the eye.

The purpose of the trial is to determine whether the new drug works at least as well as the existing treatment in preserving or improving vision. Vision will be assessed using a standard test called Best-Corrected Visual Acuity, which measures how many letters a person can read on an eye chart, reported in ETDRS letters.

Participants will receive a series of eye injections over roughly one year, with regular visits to check eye health, vision scores, and any side effects. The study is designed so that neither the participants nor the doctors know which medication is being given at each visit.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    After enrollment, study staff assign you to one of the three treatment arms using a random process. the assignment determines which medication you will receive during the trial.

  2. Step 2

    Baseline evaluation

    A comprehensive eye examination is performed before any medication is given. this includes measurement of best-corrected visual acuity (bcva), which is a test of how well you can see letters on a chart, and imaging of the retina to document the condition of neovascular age-related macular degeneration.

  3. Step 3

    First intravitreal injection

    The first injection is given directly into the eye (intravitreal injection). if you are assigned to the comparator arm, the medication is aflibercept at a dose of 2 mg. if you are assigned to the test arm, the medication is mk-8748 in a solution for intravitreal injection; the exact dose is defined by the study protocol.

  4. Step 4

    Regular follow‑up visits

    You will attend scheduled visits that occur at intervals set by the study schedule. during each visit, the study team will check your eye health, repeat the visual acuity test, and monitor for any side effects.

  5. Step 5

    Additional intravitreal injections

    Based on the study protocol, additional injections of the assigned medication are administered during the follow‑up visits. the frequency and total number of injections are determined by the trial design and continue for up to one year.

  6. Step 6

    Final assessment at year 1

    After approximately twelve months, a final evaluation is performed. the primary measurement is the change in best‑corrected visual acuity from the baseline visit to this year‑1 visit, which is used to assess the effectiveness of the treatment.

Who can join the trial?

5 criteria

  • Must have a new, never‑treated abnormal growth of blood vessels under the retina called choroidal neovascularization (CNV) caused by age‑related macular degeneration, in at least one eye; this includes growths located directly under the center of vision (subfoveal), near the center (juxtafoveal), away from the center (extrafoveal), or special types called retinal angiomatous proliferation (RAP) or polypoidal choroidal vascularization (PCV).
  • The doctor must have diagnosed neovascular age‑related macular degeneration (NVAMD) within the last 21 days before the first study treatment.
  • The loss of vision in the eye that will be studied must be judged by the doctor to be mainly caused by the NVAMD.
  • Both men and women are eligible to participate.
  • You must be an adult who falls into the age groups defined by the study (generally people 50 years of age or older).

Who cannot join the trial?

7 criteria

  • You cannot join if your blood pressure is not well‑controlled when you are screened; this means high blood pressure that has not been brought under control.
  • You cannot join if you have ever had a laser treatment called macular laser photocoagulation in the eye being studied; this is a laser used on the central part of the retina.
  • You cannot join if you have ever had uveitis, which is inflammation (swelling) inside either eye.
  • You cannot join if, within the past 90 days, you have had any of the following in the eye being studied: cataract surgery (removal of a cloudy lens), minimally invasive glaucoma surgery (small‑incision procedure to lower eye pressure), or Yttrium‑Aluminium Garnet (YAG) laser capsulotomy (laser used to clear a membrane after cataract surgery).
  • You cannot join if you have uncontrolled glaucoma in the study eye; this means eye pressure is too high and not being managed.
  • You cannot join if you have another active disease of the retina (the light‑sensing layer at the back of the eye) in the study eye besides the condition being investigated.
  • You cannot join if you have already received any anti‑vascular endothelial growth factor (VEGF) therapy (medicines that block a protein that makes abnormal blood vessels grow) or any other intravitreal (IVT) therapy (injection of medicine directly into the eye) in the study eye.
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Investigated drugs

  • Aflibercept

    is a medication that is injected directly into the eye (intravitreal injection). It works by blocking a protein that causes abnormal blood vessel growth and leakage in the back of the eye. In this trial it is used as the standard treatment to compare the new drug against, helping doctors see if the new drug works at least as well as the established therapy for neovascular age‑related macular degeneration.

  • MK-8748

    (also called EYE201) is an experimental medicine being tested for the same eye condition. Like aflibercept, it is given as an intravitreal injection. The study is looking at whether MK-8748 can improve vision and be safe for patients with neovascular age‑related macular degeneration, aiming to show that it is not worse than the standard treatment.

What is already known about the treatment

  • Aflibercept

    This medication is given as an intravitreal injection, meaning a tiny amount is placed directly into the eye using a fine needle. It is an approved drug that is widely used and well documented in medical literature for treating neovascular age‑related macular degeneration. Aflibercept works by attaching to proteins called VEGF‑A, VEGF‑B and PlGF, stopping them from causing abnormal blood vessels to grow in the retina. It belongs to the anti‑VEGF (vascular endothelial growth factor) class of eye medicines.

  • MK‑8748

    MK‑8748 is supplied as a solution for intravitreal injection, so it is also placed directly into the eye with a small needle. It is still an experimental drug being studied in clinical trials and is not yet approved for general medical use. The drug is intended for neovascular age‑related macular degeneration and works by binding to VEGF‑A, blocking the signal that leads to unwanted blood‑vessel growth in the eye. It is classified as an anti‑VEGF therapeutic agent.

Investigated diseases

Neovascular age-related macular degeneration - Neovascular age-related macular degeneration is a chronic eye condition where abnormal blood vessels grow under the macula, the central part of the retina responsible for sharp vision. These new vessels leak fluid and blood, causing swelling and distortion of the macula. Over time, the leakage leads to scar tissue formation, which gradually reduces the ability to see fine details. The disease typically progresses slowly at first, but vision loss can become more noticeable as the abnormal vessels expand. It mainly affects older adults and is a leading cause of central vision impairment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-524575-22-00Protocol codeMK-8748-002Estimated enrolment960 patientsSponsorEyebiotech Limited

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