A study to compare the efficacy and safety of AVT29 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 central part of the retina, which is the light-sensitive tissue at the back of the eye. This swelling is caused by leaking blood vessels and can lead to vision problems. The purpose of the study is to compare the effectiveness and safety of a new medication, AVT29, against a high dose of Eylea. Both medications contain the active substance aflibercept and are administered via intravitreal use, which means the medicine is injected directly into the eye.

During the study, participants will receive either AVT29 or a high dose of Eylea. The medical team will monitor changes in best-corrected visual acuity, which refers to the clearest vision possible with glasses or contact lenses. Additionally, the study will look at changes in central subfield thickness, a measurement of how much the middle part of the retina has thickened due to swelling, and the presence of intraretinal fluid, which is liquid trapped inside the layers of the retina. Regular check-ups will also be performed to monitor intraocular pressure, the fluid pressure inside the eye, and other general health factors to ensure safety throughout the process.

Who Can Join the Study?

  • You must be able to read, understand, and sign a consent form, which is a document that explains the study details and your rights before any study activities begin.
  • If you are unable to read or write, a neutral witness (someone not involved in the study) must be present while the study details are explained to you.
  • You must be 18 years of age or older at the time you sign the consent form.
  • You must have been diagnosed with Type 1 or Type 2 diabetes, which are conditions that affect how your body manages blood sugar.
  • Your HbA1c level, which is a blood test that shows your average blood sugar levels over the past two to three months, must be less than 12%.
  • You must have Diabetic Macular Edema, a condition where there is swelling in the central part of the retina (the light-sensitive tissue at the back of the eye) caused by diabetes.

Who Cannot Join the Study?

  • You have proliferative diabetic retinopathy, which is an advanced stage of eye disease caused by diabetes where new, abnormal blood vessels grow in the retina.
  • You have pre-retinal fibrosis involving the macula, which means there is scar tissue located in front of the macula (the sensitive part of the back of the eye that provides central vision).
  • You have aphakia, which is the absence of the eye’s natural lens, or you are missing the posterior capsule (the thin membrane that holds the lens in place).
  • You have had any inflammation or infection inside the eye within the last 90 days.
  • You have a history of uveitis, which is inflammation inside the eye, specifically types that are not caused by an infection (non-infectious) or those caused by the body’s own immune system (idiopathic or autoimmune).
  • You have an allergy or hypersensitivity to immunoglobulin products (proteins used in medicine to help the immune system) or any of the ingredients used in the study treatments.
  • You have uncontrolled blood pressure.
  • You have a history of vascular disease, which refers to problems with blood vessels, such as a cerebrovascular accident (a stroke), a myocardial infarction (a heart attack), a transient ischemic attack (a temporary blockage of blood flow to the brain), or a thromboembolic reaction like a pulmonary embolism (a blood clot that travels to the lungs) within the last 180 days.
  • You have heart failure classified as Class III or IV, meaning you have significant difficulty breathing or performing daily activities due to heart issues, or you have severe uncontrolled cardiac disease such as unstable angina (chest pain that occurs unexpectedly and is not predictable).

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

Other Sites

Site Name City Country Status
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
University Hospital Bratislava Bratislava Slovakia
Santa Sp. z o.o. Lodz Poland
MBAL Trakia EOOD Stara Zagora Bulgaria
Outpatient-Medical Center For Specialized Medical Care-Eye Clinic Sveta Petka AD Varna Bulgaria
Nozologen Kft. Pecs Hungary
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o. Olsztyn Poland
Fakultna Nemocnica Trencín Trencin Slovakia
University Of Debrecen Debrecen Hungary
Specialized Eye Diseases Hospital For Active Treatment-Varna EOOD Varna Bulgaria
Bajcsy-Zsilinszky Korhaz Es Rendelointezet Budapest Hungary
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Semmelweis University Budapest Hungary
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Of Szeged Szeged Hungary
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD Sofia Bulgaria
Budapest Retina Associates Budapest Hungary
Oftalmika Sp. z o.o. Bydgoszcz Poland
Riga East University Hospital – Department of Ophthalmology, Clinical Center “Bikernieki” Riga Latvia
Anmt Cgzrixnn sgpsnq Prague Czechia
Zgecrwmzknuzdo rhehjycfm szmruvvx Syl Ventspils Latvia
Vcjis svwrx s rheb Nachod Czechia
Nkzkgqfdv S Pkxotwuhyiul Tmekptru afct Trebisov Slovakia
Csspwhctc Sxv z owda Tarnowskie Gory Poland
Ssiumbv Sofivura Ljsklli Stoj Bielsko-Biala Poland
Cpdavlu Mmzovmlt Dwlhic 1e Sbg z osgl Cracow Poland
Gwhuhqt Oiklacachnsr plefc Edgpfa Wjhettha Katowice Poland
Pobdeakgz svreom Bratislava Slovakia
Mkcilyne Mtwezjh Ayngezk Pleven Bulgaria

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
18.03.2026
Czechia Czechia
Recruiting
18.03.2026
Hungary Hungary
Recruiting
18.03.2026
Latvia Latvia
Recruiting
18.03.2026
Poland Poland
Recruiting
18.03.2026
Slovakia Slovakia
Recruiting
18.03.2026

Trial locations

Investigated drugs:

Aflibercept is a medication injected into the eye to help treat swelling in the retina caused by diabetes. It works by blocking certain proteins that lead to the buildup of fluid in the eye.

Eylea is a medication injected into the eye used to treat swelling in the retina caused by diabetes. It functions by reducing the growth of abnormal blood vessels and decreasing fluid leakage in the eye.

Diabetic Macular Edema – This condition occurs when fluid leaks from damaged blood vessels in the retina, which is the light-sensitive tissue at the back of the eye. It is often a complication of diabetes, where high blood sugar levels damage the small vessels. This leakage causes the macula, the part of the retina responsible for sharp central vision, to swell. As the swelling increases, the central area of vision may become blurry or distorted. The accumulation of fluid within the retinal layers can continue to progress if the underlying vascular issues are not managed.

Trial ID:
2025-522231-34-00
Protocol code:
AVT29-GL-C01
Trial Phase:
Therapeutic confirmatory (Phase III)

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