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

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 Diabetic Macular Edema, a condition where swelling occurs in the retina, which is the light-sensitive layer at the back of the eye. The purpose of the study is to compare the effectiveness of a new treatment called EYP-1901, a type of tyrosine kinase inhibitor, against a known medication called aflibercept. While aflibercept is administered through an intravitreal injection, which involves medicine being placed directly into the eye, EYP-1901 is provided as an implant.

Participants in the study will be assigned to receive either the test medication or the comparison medication. The process involves monitoring changes in best corrected visual acuity, which refers to how clearly a person can see when wearing glasses or contact lenses. The study will observe how these treatments affect the thickness of the retina and how frequently eye treatments are required over a set period of time.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    One of two treatments is administered directly into the eye through an intravitreal injection, which means the medicine is placed into the space inside the eye. the treatment received is either EYP-1901 (a 2686 microgram implant) or aflibercept (a 2 milligram injection).

    This phase lasts for a total of 56 weeks to evaluate how much the best corrected visual acuity, which is the clearest vision possible with glasses or contacts, changes over time.

  2. Step 2

    Monitoring and follow-up

    During the 56 weeks of treatment, the thickness of the retina, which is the light-sensitive membrane at the back of the eye, is measured to track changes.

    The number of injections required is recorded throughout the 56-week period.

    The ability to maintain, gain, or lose letters on an eye chart is monitored to track vision changes.

    The progress of the diabetic macular edema, which is swelling in the center of the retina caused by diabetes, is observed to determine the speed and extent of improvement.

    After the initial 56 weeks, the need for additional aflibercept injections is tracked for up to 88 weeks to monitor the total number of extra injections required.

Who can join the trial?

9 criteria

  • Both men and women who are 18 years of age or older can join the study.
  • You must have a diagnosis of diabetes mellitus (a condition where blood sugar levels are too high), which must have been stable for at least 3 months before the study begins.
  • Your diabetes must be managed with oral medication (pills taken by mouth), insulin, or other injectable drugs (medicine given by needle).
  • Your hemoglobin A1c (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 the informed consent (a document that explains all study details and risks before you agree to participate).
  • For participants in the United States, you must agree to allow access to your personal health information through HIPAA authorization (a law that protects your medical privacy).
  • You must be willing and able to attend all scheduled appointments and follow all study rules and tests.
  • Women who may become pregnant, or men with female partners who may become pregnant, must agree to use contraception (methods used to prevent pregnancy) during the study.
  • You must have a previous diagnosis of macular edema (swelling in the part of the eye that provides detailed vision) that is caused by diabetic retinopathy (damage to the blood vessels in the retina caused by diabetes).

Who cannot join the trial?

3 criteria

  • People who have certain eye problems specifically in the eye being studied.
  • People who have certain eye problems in either of their eyes.
  • People who meet other general health or medical requirements that prevent participation.
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Investigated drugs

  • EYP-1901

    is an implant injected into the eye that works as a tyrosine kinase inhibitor to help treat diabetic macular edema.

  • Eylea

    is an injection used to treat eye conditions by targeting certain proteins that contribute to swelling in the retina.

What is already known about the treatment

  • Aflibercept

    This medication is an established treatment administered through a single injection directly into the eye. It is used primarily to treat conditions like swelling in the retina caused by diabetes. It works by binding to and blocking specific proteins in the body that cause the growth of abnormal blood vessels and leakage. This drug belongs to a class of medications known as vascular endothelial growth factor (VEGF) inhibitors.

  • Vorolanib

    This experimental medication is delivered as a tiny implant placed directly into the eye to release medicine over time. It is currently being studied to see if it can effectively treat swelling in the retina caused by diabetes. It works at a molecular level by blocking certain enzymes called tyrosine kinases that help signal the growth of harmful blood vessels. 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 light-sensitive part of the retina at the back of the eye. It is often caused by damage to the small blood vessels resulting from diabetes. As the condition progresses, the accumulation of fluid causes the central part of the retina to swell. This swelling can lead to changes in the thickness of the retina. Over time, the swelling may result in blurred or distorted central vision.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523937-25-00Protocol codeEYP-1901-303Estimated enrolment240 patientsSponsorEyepoint Inc.

sourced from the EU Clinical Trials Register and site verification

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