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Study on the Effectiveness and Safety of EYE103 Compared to Ranibizumab for 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 clinical trial is focused on studying a condition called Diabetic Macular Edema, which affects the eyes of people with diabetes and can lead to vision problems. The study will compare the effects of a new treatment called EYE103 with an existing medication known as ranibizumab. Both treatments are given as a solution for injection directly into the eye, a method known as intravitreal use.

The purpose of the study is to evaluate whether EYE103 is as effective as ranibizumab in improving vision in people with Diabetic Macular Edema. Participants in the study will receive either EYE103 or ranibizumab over a period of time, and their vision will be monitored to see how it changes. The study will last for about a year, with regular check-ups to assess the effects of the treatment.

During the study, participants will have their vision tested using a standardized chart called the ETDRS chart, which helps measure changes in vision clarity. The study aims to determine if EYE103 can provide similar benefits to ranibizumab in terms of improving vision over the course of the study. This research is important for finding effective treatments for people with Diabetic Macular Edema and improving their quality of life.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants will be required to provide written informed consent. This confirms understanding of the study procedures and the associated risks.

    Participants must be at least 18 years old. Female participants of childbearing potential must have a negative pregnancy test before each dose and agree to use effective contraception during the study and for three months after the last dose. Male participants must agree to use contraception during the study and for 90 days after the last dose.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to establish a baseline for the study. This includes measuring the **BCVA** (Best Corrected Visual Acuity) using the standardized **ETDRS** (Early Treatment Diabetic Retinopathy Study) chart.

  3. Step 3

    Treatment administration

    Participants will be randomly assigned to receive either **EYE103** or **ranibizumab**. Both are administered as a solution for injection directly into the eye, a process known as **intravitreal use**.

    The dosage for **ranibizumab** is 0.5 mg. For **EYE103**, the dosage may be either 0.5 mg or 0.8 mg. The frequency and duration of administration will be determined by the study protocol.

  4. Step 4

    Ongoing assessments

    Throughout the study, regular assessments will be conducted to monitor changes in **BCVA**. These assessments will occur up to and including Week 52.

    The primary goal is to evaluate the change in vision from the start of the study to the end of the first year.

  5. Step 5

    Completion of study

    The study is expected to conclude by June 30, 2028. Participants will have completed all required assessments and treatments by this time.

    Final evaluations will be conducted to assess the overall efficacy and safety of the treatments.

Who can join the trial?

4 criteria

  • Participants must be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity.
  • Be male or female and at least 18 years old.
  • If female, have a negative blood pregnancy test at the start and further negative urine tests before each dose of study medication if the participant is a female who can have children. This includes those who have had less than 2 years since the start of menopause, have not had a period for less than 1 year, or are not surgically unable to have children. Such participants must agree to use a highly effective method of birth control from the start of the study up to and including 3 months after the last dose of study drug. She must also agree not to donate eggs from the start of the study up to and including 3 months after the last dose of study drug.
  • If male, be surgically unable to have children for at least 12 weeks, or agree to use an acceptable method of birth control, such as a condom, and a second highly effective method of birth control from the start of the study up to and including 90 days after the last dose of study drug. He must also agree not to donate sperm from the time of the first dose until 12 weeks after the last dose of study drug.

Who cannot join the trial?

10 criteria

  • Patients with any other eye disease that could affect vision.
  • Patients who have had eye surgery in the last 3 months.
  • Patients with an eye infection or inflammation.
  • Patients who are allergic to any of the study medications.
  • Patients who are pregnant or breastfeeding.
  • Patients with uncontrolled diabetes or high blood pressure.
  • Patients who have had a stroke or heart attack in the last 6 months.
  • Patients who are participating in another clinical trial.
  • Patients with a history of drug or alcohol abuse.
  • Patients with any condition that the study doctor thinks would make it unsafe for them to participate.
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Investigated drugs

  • EYE103

    is a medication being tested in this clinical trial to see if it can help people with diabetic macular edema, a condition that affects the eyes and can lead to vision problems. This medication is given as an injection directly into the eye. The goal is to see if it can improve vision or at least prevent it from getting worse, by comparing it to another medication already used for this condition.

  • Ranibizumab

    is a medication already used to treat diabetic macular edema. It is also given as an injection into the eye. This medication works by blocking a substance in the body that can cause abnormal blood vessels to grow in the eye, which can lead to vision problems. In this trial, it is used as a comparison to see if the new medication, EYE103, is just as effective or better at treating the condition.

What is already known about the treatment

  • EYE103

    EYE103 is administered through an injection directly into the eye, a method known as intravitreal injection. It is currently being studied in clinical trials to assess its effectiveness and safety for treating Diabetic Macular Edema, a condition that affects vision. The main goal of the study is to show that EYE103 is as effective as the existing medication ranibizumab in improving vision over a year. EYE103 works by targeting specific molecules in the eye to reduce swelling and improve vision. It belongs to a class of drugs that help manage eye conditions by controlling abnormal blood vessel growth and leakage.

  • Ranibizumab

    Ranibizumab is also administered through an injection directly into the eye, known as an intravitreal injection. It is an established medication used to treat Diabetic Macular Edema, a condition that can lead to vision loss. Ranibizumab works by blocking a protein that causes abnormal blood vessel growth and leakage in the eye, helping to reduce swelling and improve vision. It is part of a group of medications that help manage eye conditions by targeting specific pathways involved in disease progression.

Investigated diseases

Diabetic Macular Edema – Diabetic Macular Edema is a condition that affects the eyes, specifically the macula, which is the part of the retina responsible for sharp, central vision. It occurs when blood vessels in the retina leak fluid, causing the macula to swell. This swelling can lead to blurred or wavy vision and can affect the ability to see fine details. The progression of the disease is often gradual, with symptoms worsening over time if not managed. It is commonly associated with diabetes and can occur in individuals with both type 1 and type 2 diabetes. The condition can affect one or both eyes and is a common cause of vision impairment in people with diabetes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-520809-12-00Protocol codeEYE-RES-103Estimated enrolment960 patientsSponsorEyebiotech Limited

sourced from the EU Clinical Trials Register and site verification

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