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Study on the Effectiveness of Dexamethasone Implant 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 use a treatment called Ozurdex, which is an implant that releases a medication named Dexamethasone directly into the eye. This medication is designed to help reduce swelling and improve vision in patients with this condition.

The purpose of the study is to evaluate how effective this new treatment regimen is over a period of one year. Participants will receive the Ozurdex implant and will be monitored regularly to assess changes in their vision. The study will track improvements in visual acuity, which is the clarity or sharpness of vision, and will also record any discomfort experienced from the implant. The study will last for up to two years, with regular check-ups to monitor progress and any side effects.

Throughout the study, the number of injections and changes in the condition of the eye will be carefully observed. The study aims to provide valuable information on how well the treatment works and how it affects the eye over time. Participants will be closely monitored to ensure their safety and to gather data on the treatment's effectiveness in managing Diabetic Macular Edema.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Visit and Screening

    The initial visit involves a comprehensive eye examination to confirm eligibility for the study. This includes measuring the central macular thickness and visual acuity.

    Eligibility criteria include being over 40 years old, having significant diabetic macular edema, and meeting specific health conditions such as controlled blood pressure and HbA1c levels.

  2. Step 2

    First Treatment Administration

    The first administration of the Ozurdex intravitreal implant occurs. This implant contains dexamethasone, a medication used to reduce inflammation and swelling in the eye.

    The implant is placed directly into the eye through a procedure known as intravitreal injection.

  3. Step 3

    Follow-up Visits

    Monthly follow-up visits are scheduled for the first year. During these visits, visual acuity and eye health are assessed.

    The number of injections and any changes in vision are recorded. Patient discomfort is also evaluated using a visual analog scale.

  4. Step 4

    Midpoint Evaluation

    At 12, 24, and 36 weeks, a detailed evaluation of the eye's condition is conducted. This includes checking for any changes in diabetic retinopathy and macular edema resolution.

    The central macular thickness and other eye structures are analyzed using imaging techniques.

  5. Step 5

    End of Year One Assessment

    At 52 weeks, the primary endpoint is assessed by comparing the best corrected visual acuity from the start of the study to the highest value observed during the year.

    The total number of injections and any adverse events are documented.

  6. Step 6

    Extended Follow-up

    Follow-up continues at 18 and 24 months to monitor long-term effects and any changes in vision or eye health.

    The study aims to describe the time required to reach the highest visual acuity value and the overall effectiveness of the treatment over two years.

  7. Step 7

    Final Evaluation

    At the end of the study period, a comprehensive evaluation is conducted to assess the overall outcomes of the treatment protocol.

    The final assessment includes a review of visual acuity improvements, the condition of the eye, and any long-term adverse effects.

Who can join the trial?

11 criteria

  • Patient over 40 years old
  • Patient willing and able to return for all study clinical visits and to complete all related procedures
  • Patient with significant **diabetic macular oedema** (DMO):
    • A central macular thickness (CMT) of at least 285 micrometers (μm) measured by a special eye scan called Spectralis/Topcon SD-OCT, or at least 275 μm measured by Cirrus SD-OCT
    • Visual acuity, which is how well you see, between 20/32 and 20/230, measured using a specific scale called the ETDRS scale, following the measurement protocol at a distance of 4 meters
    • Patient for whom it has been decided to insert an intra-retinal **dexamethasone implant**
    • Eye has not received any drug treatment before (no previous intravitreal corticosteroid or anti-VEGF treatment)
    • Patient has had cataract surgery and has an artificial lens (pseudophakic) for at least 3 months
    • **HBA1c** level, which is a measure of blood sugar control, is less than 10%
    • Blood pressure is less than 160/95 mmHg
    • Patient who has given their free, informed, and signed consent
    • Patient affiliated with a social security scheme or equivalent

Who cannot join the trial?

9 criteria

  • Patients who have any other eye disease that could affect their vision.
  • Patients who have had eye surgery in the last 3 months.
  • Patients who are allergic to any of the ingredients in the study medication.
  • Patients who are pregnant or breastfeeding.
  • Patients who have uncontrolled diabetes, meaning their blood sugar levels are not stable.
  • Patients who have a history of severe heart problems.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have any condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

Ozurdex: This is an implant that is placed inside the eye to help treat diabetic macular edema. It contains a medication called dexamethasone, which is a type of steroid. The implant slowly releases the medication over time to reduce swelling and improve vision in patients with this eye condition.

What is already known about the treatment

Ozurdex – This medication is administered as an intravitreal implant, meaning it is placed directly into the eye. It is currently used in medical practice and literature for treating diabetic macular edema, a condition that affects vision. The main therapeutic indication for Ozurdex is to improve visual acuity in patients with this condition. At the molecular level, it works by releasing dexamethasone, a corticosteroid, which reduces inflammation and swelling in the retina. Ozurdex is classified pharmacologically as a corticosteroid implant.

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 fluid accumulates in the macula due to leaking blood vessels, often as a complication of diabetes. This fluid buildup causes the macula to swell, leading to blurred or distorted vision. Over time, if untreated, it can result in significant vision impairment. The progression of the disease is closely linked to the management of diabetes and the control of blood sugar levels. Regular eye examinations are crucial for detecting changes in the retina and managing the condition effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514362-39-00Protocol code69HCL19_0588Estimated enrolment100 patientsSponsorHospices Civils De Lyon

sourced from the EU Clinical Trials Register and site verification

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