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Study on EYE103 and 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 treatment known as Ranibizumab. Both treatments are given as injections directly into the eye, a method known as intravitreal use. The purpose of the study is to see if EYE103 is as effective as Ranibizumab in improving vision.

Participants in the study will receive either EYE103 or Ranibizumab, or a placebo, over a period of time. The study will last for about a year, during which participants will have regular check-ups to monitor their vision and overall eye health. The main goal is to measure changes in vision using a special eye chart designed for people with diabetic eye conditions. This will help determine if EYE103 can maintain or improve vision as effectively as the current treatment.

In addition to EYE103 and Ranibizumab, a substance called Fluorescein Sodium may be used during the study. This is a type of contrast agent that helps doctors see the blood vessels in the eye more clearly during examinations. The study aims to provide valuable information about the safety and effectiveness of EYE103 for people with Diabetic Macular Edema, potentially offering a new option for managing this condition.

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

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, you will undergo a series of assessments to confirm your eligibility for the trial. This includes a review of your medical history and a comprehensive eye examination.

    If you are a female participant of childbearing potential, a pregnancy test will be conducted to ensure eligibility. You will also be required to agree to use an acceptable method of contraception during the study and for 30 days after the last dose of the study drug.

  2. Step 2

    Randomization and first treatment

    After confirming eligibility, you will be randomly assigned to one of the study groups. This means you will receive either EYE103 or ranibizumab (also known as Lucentis).

    The first dose of the study medication will be administered through an injection into the eye, a procedure known as intravitreal use. The dosage for EYE103 will be either 0.5 mg or 0.8 mg, while ranibizumab will be administered at a dose of 0.5 mg.

  3. Step 3

    Follow-up visits

    You will attend regular follow-up visits throughout the study period, which lasts up to 52 weeks. These visits are crucial for monitoring your response to the treatment and ensuring your safety.

    During these visits, your vision will be assessed using a standardized chart to measure any changes in your visual acuity. This is known as the ETDRS chart, which stands for Early Treatment of Diabetic Retinopathy Study.

  4. Step 4

    Ongoing treatment

    You will continue to receive the assigned study medication at regular intervals as determined by the study protocol. The frequency of these injections will be explained to you during your visits.

    It is important to attend all scheduled appointments and follow the instructions provided by the study team to ensure the best possible outcomes.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment will be conducted. This will include a comprehensive eye examination and a review of your overall health status.

    The primary goal of this assessment is to evaluate the change in your visual acuity from the start of the study to the end, using the ETDRS chart.

Who can join the trial?

4 criteria

  • 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 pregnancy test at the start of the study and further negative tests before each dose of study medication if you are of childbearing potential. This includes women 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 sterile. You must agree to use an acceptable method of birth control for 30 days after the last dose of study drug.
  • If male, be surgically sterile 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.

Who cannot join the trial?

4 criteria

  • Patients who do not have Diabetic Macular Edema cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important to check if you qualify.
  • Both male and female patients are eligible, so gender is not a reason for exclusion.
  • Patients who are part of a vulnerable population are not eligible. This typically means groups that may need special protection, like children or those unable to give consent.
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Investigated drugs

  • EYE103

    is a new medication being tested in this clinical trial. It is given as an injection into the eye and is being studied to see if it can help improve vision in people with diabetic macular edema, a condition that affects the retina and can lead to vision loss. The goal is to see if EYE103 can work as well as another treatment already used for this condition.

  • Ranibizumab

    is a medication that is already used to treat diabetic macular edema. It is also given as an injection into the eye. Ranibizumab works by blocking a protein that can cause abnormal blood vessels to grow and leak in the eye, which can lead to vision problems. In this trial, it is being used as a comparison to see how well EYE103 performs in improving vision.

What is already known about the treatment

  • EYE103

    EYE103 is administered through an injection directly into the eye, 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 medication works by targeting and inhibiting specific proteins that contribute to abnormal blood vessel growth and leakage in the eye, which can lead to vision problems. EYE103 is classified as an anti-VEGF (vascular endothelial growth factor) agent, a type of medication used to manage eye conditions related to abnormal blood vessel growth.

  • Ranibizumab

    Ranibizumab is also administered via intravitreal injection, directly into the eye. It is an established medication used in the treatment of Diabetic Macular Edema and other eye conditions. Ranibizumab functions by blocking a protein called VEGF, which is responsible for the growth of abnormal blood vessels in the eye that can cause vision impairment. It belongs to the pharmacological class of anti-VEGF agents, which are commonly used to treat various retinal diseases.

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 linked to the duration and control of diabetes, with prolonged high blood sugar levels increasing the risk. Over time, the accumulation of fluid can cause persistent vision problems if not managed. The condition is a common complication of diabetic retinopathy, which is a broader term for diabetes-related damage to the retina.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-510944-30-00Protocol codeEYE-RES-102Estimated enrolment960 patientsSponsorEyebiotech Limited

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