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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Nozologen Kft. Pecs Hungary
University Of Debrecen Debrecen Hungary
Bajcsy-Zsilinszky Korhaz Es Rendelointezet Budapest Hungary
St. Elisabeth Krankenhaus GmbH Cologne Germany
Semmelweis University Budapest Hungary
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Of Pecs Pecs Hungary
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
University Of Szeged Szeged Hungary
Budapest Retina Associates Budapest Hungary
Amgp Cutclzts spnoul Prague Czechia
Vejrh sndzf s rleb Nachod Czechia
Mnuewmx Pjqbcrw Cpvv swhvos Sokolov Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Recruiting
25.05.2026
Germany Germany
Recruiting
25.05.2026
Hungary Hungary
Recruiting
25.05.2026

Trial locations

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.

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 ID:
2025-523938-10-00
Protocol code:
EYP-1901-304
Trial Phase:
Therapeutic confirmatory (Phase III)

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