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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 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 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.

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

    You will receive an injection into the eye, a procedure called intravitreal use, to treat diabetic macular edema, which is swelling in the part of the eye that provides detailed vision.

    You will receive either aflibercept (8 mg) or eylea high dose (8 mg) as an injection into the eye.

  2. Step 2

    Monitoring and evaluation

    Throughout the study, visual acuity, which is the clarity of vision, will be measured using a standardized eye chart to track changes in how well you see.

    The thickness of the central part of the retina will be measured using a specialized light scan called optical coherence tomography to check for intraretinal fluid, which is liquid buildup inside the eye layers.

    Various medical assessments will be performed, including checks of intraocular pressure (the pressure inside the eye), examinations of the eye structure, and monitoring of general health and safety parameters.

Who can join the trial?

6 criteria

  • 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 trial?

9 criteria

  • 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).
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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.

What is already known about the treatment

  • Aflibercept

    This medication is administered as a liquid injection directly into the eye to treat swelling in the retina caused by diabetes. It is an established treatment used widely in medical practice to manage vision issues related to eye diseases. The drug works by acting like a sponge to soak up specific proteins in the body that trigger the growth of leaky blood vessels. It belongs to a group of medicines known as vascular endothelial growth factor inhibitors.

  • Eylea

    This medicine is given as a solution through a direct injection into the eye to help treat swelling in the central part of the retina. It is a well-known and approved medication used by doctors to manage various eye conditions. On a molecular level, it functions by blocking certain proteins that cause abnormal blood vessel growth and leakage. This drug is classified as a type of therapy that targets growth factors to protect vision.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522231-34-00Protocol codeAVT29-GL-C01Estimated enrolment301 patientsSponsorAlvotech Swiss AG

sourced from the EU Clinical Trials Register and site verification

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