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A study comparing the effectiveness of vorolanib and aflibercept in patients with diabetic macular edema

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What is this trial about?

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

This study aims to evaluate the effectiveness of a new treatment for Diabetic Macular Edema, a condition where swelling occurs in the central part of the retina, which is the light-sensitive layer at the back of the eye. The research compares a new medication called EYP-1901, which is a tyrosine kinase inhibitor delivered via an implant, against aflibercept, which is provided as a liquid injection into the eye. The implant is a small device placed inside the eye to release medicine over time, while the other treatment is a standard solution for injection.

During the study, participants will receive either the new implant or the standard injection. The process involves monitoring changes in best corrected visual acuity, which refers to the clearest vision a person can achieve with glasses or contact lenses. Researchers will also observe changes in the thickness of the retina and how well participants can read letters on an eye chart over a period of time. The study will track how often additional treatments are required and how the swelling in the eye responds to the different options provided.

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

    <b>initial treatment phase</b>

    You will receive one of two treatments for diabetic macular edema, which is a condition involving swelling in the light-sensitive part of the eye. the first option is an implant called eyp-1901 (vorolanib) containing 2686 micrograms, which is placed directly into the eye via intravitreal use, meaning an injection into the space inside the eye.

    The second option is a comparator medication called eylea (aflibercept). this involves an injection of 2 milligrams directly into the eye through intravitreal use.

  2. Step 2

    <b>monitoring period</b>

    Over a period of 56 weeks, the effectiveness of the treatment is measured by changes in best corrected visual acuity, which refers to how well you can see using glasses or contact lenses.

    During this time, the thickness of the retina, which is the light-sensitive membrane at the back of the eye, is monitored to observe any changes from the first treatment.

  3. Step 3

    <b>extended observation</b>

    Up to 88 weeks, the frequency of additional aflibercept injections required is tracked to determine how many extra doses are needed.

Who can join the trial?

9 criteria

  • You must be a man or a woman who is at least 18 years old.
  • You must have a diagnosis of diabetes mellitus, which is a condition where blood sugar levels are too high, and this condition must have been stable for at least 3 months.
  • Your diabetes must be managed using oral medications (pills taken by mouth), insulin, or other injectable drugs.
  • Your Hemoglobin A1c, which is a blood test that shows your average blood sugar levels over the past few months, must be less than 10%.
  • You must be able to understand and be willing to sign an informed consent form, which is a document that explains all the details of the study before you agree to join.
  • If you are in the United States, you must be willing to allow the study team to access your personal health information through a standard legal authorization.
  • You must be willing and able to follow all scheduled visits, rules, and medical tests required by the study.
  • Women who could become pregnant, or men with partners who could become pregnant, must agree to use contraception (methods to prevent pregnancy) during the study.
  • You must have a history of macular edema, which is swelling in the center of the retina (the light-sensitive part of the eye), caused by diabetic retinopathy, a type of eye damage caused by diabetes.

Who cannot join the trial?

3 criteria

  • You will not be able to participate if you have eye problems that specifically affect only the study eye, which is the eye being tested in this research.
  • You will not be able to participate if you have eye problems that affect either eye, meaning one or both of your eyes.
  • You will not be able to participate if you meet any general exclusion criteria, which are standard rules used to decide if a person is healthy enough or suitable enough to join a medical study.
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Investigated drugs

  • EYP-1901

    is an experimental implant injected into the eye. It is designed to release medicine slowly over time to help treat swelling in the retina caused by diabetes.

  • Eylea

    is an injection used to treat swelling in the retina. It works by blocking certain proteins in the eye that cause fluid buildup and vision problems.

What is already known about the treatment

  • Aflibercept

    This medication is a liquid solution administered via an injection directly into the eye. It is currently an established treatment used to manage eye conditions like diabetic macular edema by blocking certain proteins that cause swelling and leaking in the retina. It works by acting like a sponge to soak up specific growth factors that trigger abnormal blood vessel growth. This drug is classified as an anti-angiogenic agent.

  • Vorolanib

    This medication is administered as a tiny implant placed directly into the eye to release medicine slowly over time. It is currently being studied in clinical trials to see how well it treats conditions such as diabetic macular edema. It works at the molecular level by blocking specific enzymes called tyrosine kinases, which helps prevent the signals that lead to harmful blood vessel growth. This substance is classified as a tyrosine kinase inhibitor.

Investigated diseases

Diabetic Macular Edema - This condition occurs when fluid leaks into the macula, which is the central part of the retina responsible for sharp, detailed vision. It is often caused by damage to the small blood vessels in the eye due to diabetes. As the disease progresses, the buildup of fluid can cause the retina to become thick and swollen. This swelling can lead to changes in the shape of the macula. Over time, the accumulation of fluid may impact the clarity and precision of central vision.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523938-10-00Protocol codeEYP-1901-304Estimated enrolment240 patientsSponsorEyepoint Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).