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 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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Nemocnica Poprad a.s. Poprad Slovakia
Technische Universitaet Dresden Dresden Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany

Other Sites

Site Name City Country Status
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Warszawski Szpital Okulistyczny Sp. z o.o. Warsaw Poland
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o. Olsztyn Poland
Centrum Medyczne Uno-Med Sp. z o.o. Tarnow Poland
Oftalmika Sp. z o.o. Bydgoszcz Poland
Nxptbotkn S Pqeanlfmidom Tcojvttq avyv Trebisov Slovakia
Ouajtkbsajs Sga z oqhv Bydgoszcz Poland
Ppxosuhby stsjss Bratislava Slovakia
Gkkaryz Oevggdjjgwqe Jmdym Mswsyifqla Lublin Poland

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

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
28.05.2026
Poland Poland
Recruiting
28.05.2026
Slovakia Slovakia
Recruiting
28.05.2026

Trial locations

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.

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 ID:
2025-523937-25-00
Protocol code:
EYP-1901-303
Trial Phase:
Therapeutic confirmatory (Phase III)

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