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Study Comparing Fluocinolone Acetonide and Dexamethasone Implants for Patients with Resistant 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 (DME), which affects the eyes of people with diabetes and can lead to vision problems. The study will compare two treatments: the Fluocinolone Acetonide implant, known as ILUVIEN, and the Dexamethasone implant, known as OZURDEX. Both treatments are small devices placed inside the eye to help reduce inflammation and swelling, which can improve vision.

The purpose of the study is to evaluate the cost-effectiveness of these treatments over a period of three years. Participants will receive either the ILUVIEN or OZURDEX implant and will be monitored regularly to assess their vision and eye health. The study will also look at the overall impact of these treatments on quality of life and healthcare costs.

Throughout the study, participants will have follow-up visits to check their vision and eye condition. The study aims to provide valuable information on which treatment may be more beneficial for patients with resistant DME, helping to guide future treatment decisions. A placebo will not be used in this study.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must provide informed and written consent.
Eligibility includes being 18 years or older, having diabetic macular oedema (DME) with specific characteristics, and being pseudophakic, which means having had cataract surgery more than 6 months ago.
Step 2
Initial assessment
An initial assessment will be conducted to measure the central retinal thickness and best-corrected visual acuity (BCVA) using the ETDRS chart.
This assessment helps establish a baseline for future comparisons.
Step 3
Treatment administration
The patient will receive either a fluocinolone acetonide implant or a dexamethasone implant.
Both treatments are administered via an intravitreal implant, which means the medication is placed directly into the eye.
Step 4
Follow-up visits
Follow-up visits will occur regularly to monitor the patient's condition and response to treatment.
During these visits, BCVA and central retinal thickness will be measured again to track changes over time.
Step 5
Evaluation of outcomes
The primary outcome is the cost-utility ratio over 3 years, expressed in terms of cost per year of life gained in good health.
Secondary outcomes include changes in BCVA, central retinal thickness, quality of life scores, and any adverse events.
Step 6
Completion of the study
The study is expected to conclude by April 28, 2030.
Final assessments will be conducted to evaluate the long-term effects and benefits of the treatment.

Who can join the trial?

7 criteria

Patients who have given their free, informed, and written consent.
Patients aged 18 and over.
Patients with **Diabetic Macular Oedema (DME)**, which is a condition affecting the eye, with a central foveolar thickness greater than 300 microns. This thickness should still be present after at least 2 years of treatment and should be causing a drop in visual activity, meaning reduced vision less than 6/10.
Patients who have had at least one **DXM injection** that was effective both anatomically and functionally for more than 5 months. DXM is a type of treatment for the eye.
Patients who have had an **anti-VEGF injection** for more than 3 months. Anti-VEGF is another type of treatment for the eye.
**Pseudophakic patients**, meaning those who have had cataract surgery, with the surgery being more than 6 months ago.
Patients with **uni- or bilateral diabetic macular oedema**. This means the condition can be in one eye or both eyes. If both eyes are affected, the study will focus on the eye that is more affected.

Who cannot join the trial?

6 criteria

Patients who are not diagnosed with Diabetic Macular Oedema cannot participate. This is a condition where fluid builds up in the part of the eye called the macula, which can affect vision.
Patients who are not pseudophakic cannot participate. Pseudophakic means that the patient has had cataract surgery and now has an artificial lens in the eye.
Patients who are not resistant to previous treatments for Diabetic Macular Oedema cannot participate. This means that the condition has not improved with other treatments.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients are eligible, so gender is not an exclusion criterion.
Patients who are considered part of a vulnerable population are not excluded, meaning they can participate if they meet other criteria.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
CHU Grenoble Alpes
Verified
La Tronche, France
Centre Hospitalier Intercommunal Creteil
Verified
Creteil, France

Trial locations

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Investigated drugs

Fluocinolone Acetonide Implant
is a small device placed inside the eye to release medication over time. It is used to treat diabetic macular edema, a condition where fluid builds up in the retina, causing vision problems. This implant helps reduce inflammation and swelling in the eye, potentially improving vision.
Dexamethasone Implant
is another type of implant used in the eye to treat diabetic macular edema. Like the fluocinolone acetonide implant, it releases medication slowly to reduce inflammation and swelling in the retina. This can help improve vision in patients with this condition.

What is already known about the treatment

Fluocinolone Acetonide
This medication is administered as an intravitreal implant, meaning it is placed directly into the eye. It is currently being evaluated in clinical trials for its effectiveness in treating diabetic macular edema, particularly in cases resistant to other treatments. The main therapeutic indication is to reduce inflammation and swelling in the eye, which can help improve vision. At the molecular level, fluocinolone acetonide works by inhibiting the release of substances in the body that cause inflammation. It is classified as a corticosteroid.
Dexamethasone
This medication is also administered as an intravitreal implant, directly into the eye. It is being studied for its use in treating diabetic macular edema, especially in patients who have not responded to other treatments. The primary therapeutic indication is to decrease inflammation and swelling in the eye, potentially improving vision. Dexamethasone acts by suppressing the immune response and reducing inflammation at the molecular level. It belongs to the pharmacological class of corticosteroids.

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 and thicken. This swelling can lead to blurred or distorted vision, making it difficult to read, drive, or recognize faces. The progression of the disease can vary, with some individuals experiencing gradual worsening of vision over time. It is commonly associated with diabetes and can occur in individuals with both type 1 and type 2 diabetes. Regular monitoring and management of blood sugar levels are important in managing the condition.