Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

A Phase 2/3 Study of intravitreal mk-8748 versus aflibercept in adults with neovascular age‑related macular degeneration

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

The study focuses on Neovascular age-related macular degeneration, a condition where abnormal blood vessels grow under the retina and can cause loss of sight. Two eye‑injection medicines are being compared: a new investigational drug called MK-8748 (also referred to as EYE201) and an approved drug called aflibercept. A dye called fluorescein sodium is also used during eye examinations to help doctors see the blood vessels more clearly.

The purpose of the trial is to determine whether MK-8748 is at least as effective as aflibercept in preserving or improving vision. Participants will receive a series of injections into the eye over the course of about one year, with regular visits for eye checks, vision testing, and imaging that may involve the fluorescein dye.

Vision is measured using best-corrected visual acuity, which is the sharpest vision possible with the best glasses or contacts, and the results are recorded as letters on an ETDRS chart, a standard eye‑test chart. Throughout the study, doctors will monitor participants for any side effects or safety concerns.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and group assignment

    After joining the study you are placed into one of three groups. the groups receive either mk-8748 (the test medication), aflibercept (the comparator medication), or background imaging with fluorescein.

    The assignment is done by the study system and you are not required to choose a group.

  2. Step 2

    Baseline eye assessment

    A comprehensive eye examination is performed before any medication is given.

    Your best-corrected visual acuity (the sharpest vision you can achieve with glasses or contacts) is measured using a standardized letter chart.

    Imaging of the retina is done, which may include the use of fluorescein dye to highlight blood vessels.

  3. Step 3

    First intravitreal injection

    The first injection is given directly into the eye (intravitreal injection).

    If you are in the comparator group you receive aflibercept at a dose of 2 mg per injection.

    If you are in the test group you receive mk-8748 at the dose specified by the study formulation (dose amount not disclosed in the public information).

    The injection is performed by a qualified eye specialist under sterile conditions.

  4. Step 4

    Subsequent injection visits

    Additional injections are scheduled according to the study protocol throughout the first year.

    Each injection uses the same dose and route as the first injection (2 mg aflibercept or the study‑specified dose of mk-8748 administered intravitreally).

    The exact interval between injections (for example monthly or every eight weeks) is determined by the study schedule.

  5. Step 5

    Regular follow‑up examinations

    At each visit you undergo a visual acuity test to track changes in your sight.

    The eye specialist checks for any side effects or safety concerns related to the injections.

    Retinal imaging may be repeated, sometimes using fluorescein dye, to monitor the condition of the macula.

  6. Step 6

    Primary efficacy assessment at one year

    After approximately twelve months, a final assessment is performed to determine the change in best‑corrected visual acuity compared with the baseline measurement.

    This assessment is the main outcome used to evaluate whether mk-8748 is non‑inferior to aflibercept.

  7. Step 7

    Study completion

    Once the one‑year assessment is finished, the participant’s involvement in the trial ends.

    Any further care or treatment decisions are made by the treating physician outside the study protocol.

Who can join the trial?

5 criteria

  • You have a new (treatment‑naive) choroidal neovascularization (CNV) caused by age‑related macular degeneration in at least one eye (the eye that will be studied). This abnormal growth of tiny blood vessels may be directly under the center of vision (subfoveal), next to it (juxtafoveal), farther away (extrafoveal), or you may have a type called retinal angiomatous proliferations (RAP) or polypoidal choroidal vascularization (PCV) lesions.
  • A doctor must have diagnosed you with neovascular age‑related macular degeneration (NVAMD) within the past 21 days before you start the study medication.
  • You must have a loss of vision in the study eye that the doctor believes is mainly due to NVAMD.
  • Both men and women are allowed to join the study.
  • You must be an adult who meets the study’s age limits (the trial includes participants who are at least 18 years old).

Who cannot join the trial?

7 criteria

  • Having blood pressure that is not under control when screened – this means the pressure in your arteries is too high and has not been properly managed.
  • Having had any previous macular laser photocoagulation in the eye being studied – this is a laser treatment used on the central part of the retina (the macula) to treat eye problems.
  • Having a history of uveitis in either eye – uveitis is inflammation inside the eye that can affect vision.
  • Having had cataract surgery, minimally invasive glaucoma surgery, or a YAG laser capsulotomy in the study eye within the past 90 days – these are procedures to remove cataracts, treat glaucoma with a small surgery, or clear cloudiness after cataract surgery, and they must have been done more than three months ago.
  • Having glaucoma in the study eye that is not under control – glaucoma is a disease that damages the optic nerve due to pressure inside the eye, and “uncontrolled” means the pressure is still too high despite treatment.
  • Having any other active eye disease of the retina in the study eye – this means there is a current, ongoing problem in the back part of the eye that is not the condition being studied.
  • Having previously received anti‑vascular endothelial growth factor (VEGF) therapy or any other intravitreal (IVT) therapy in the study eye – these are medicines injected directly into the eye to treat certain eye diseases, and prior use disqualifies participation.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Aflibercept

    is a medication that is injected directly into the eye. It works by blocking a protein that causes abnormal blood vessels to grow and leak in the retina. In this study it is used as the standard treatment to compare the new drug against.

  • MK-8748

    is an experimental medicine being tested for the first time in people with age‑related macular degeneration. Like other drugs for this condition, it is given by injection into the eye and is intended to stop the growth of harmful blood vessels and improve vision. The trial is checking whether it works as well as the approved medicine.

  • Fluorescein

    is a bright‑colored dye that doctors use during eye examinations. It is injected into a vein and then photographed as it travels through the blood vessels in the eye. In this trial it helps doctors see how the blood vessels are responding to the treatments.

What is already known about the treatment

  • Aflibercept

    This medicine is given by a tiny injection directly into the eye (intravitreal) at a dose of 2 mg. It is an approved drug that is widely used and well described in medical literature. It is mainly used to treat neovascular age‑related macular degeneration and other eye conditions caused by abnormal blood vessel growth. It works by attaching to proteins that tell blood vessels to grow, thereby stopping new, leaky vessels from forming, and is classified as an anti‑VEGF (vascular endothelial growth factor) agent.

  • Fluorescein sodium

    Fluorescein is applied as a dye, usually injected into a vein, and then examined with a special camera that shows the blood vessels in the eye. It is an established diagnostic agent that has been used for many years and is listed in medical references. Its main purpose is to help doctors see the circulation in the retina during fluorescein angiography, not to treat disease. The dye lights up under blue light, highlighting vessels, and it is classified as a diagnostic ophthalmic dye.

  • MK‑8748

    MK‑8748 is supplied as a sterile solution for injection into the eye (intravitreal) and is still being studied in clinical trials. It is an investigational drug that has not yet received market approval but is in Phase 2/3 testing for eye disease. The target condition is neovascular age‑related macular degeneration, where it aims to stop abnormal blood vessel growth. It works by blocking the same growth‑promoting proteins that cause new vessels to form, and it is classified as an experimental anti‑VEGF therapy.

Investigated diseases

Neovascular age-related macular degeneration - Neovascular age-related macular degeneration is a progressive eye disease that affects the central part of the retina called the macula. In this form of AMD, abnormal blood vessels grow beneath the macula and can leak fluid or blood. The leakage can cause swelling, distortion, and a gradual decline in sharp, central vision. It usually develops in people over the age of 60 and often follows an earlier, non‑vascular form of age‑related macular degeneration. As the abnormal vessels continue to grow, the damage to the macular tissue increases, making reading, driving, and recognizing faces more difficult. Vision changes may become more noticeable over months to years.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-524894-17-00Protocol codeMK-8748-003Estimated enrolment965 patientsSponsorEyebiotech Limited

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.