Study on the Effectiveness of Dexamethasone Implant for Patients with Diabetic Macular Edema

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Intercommunal Creteil	Creteil	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Selarl Retine Tourny	Bordeaux	France
Centre Monticelli Paradis D Ophtalmologie	Marseille	France
Centre Hospitalier D Avignon	Avignon	France
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer	Toulon	France
clinique juge	Marseille	France
Quinze-Vingts National Ophthalmology Hospital	Paris	France
Centre Hospitalier Universitaire De Nice	Nice	France
Pole Vision Val D’Ouest	Ecully	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Cyesfxy djfzabmxewvsirnixzirf dp Dr Dppda Dp Lbhbdzi	Quint-Fonsegrives	France
Clxbamiy Mouglksi	Rouen	France
Gmaqvdgrov Hqkmhhzvpji Ejrpuxzu Micabneogpo Svqdxo Vngz	Eaubonne	France
Cafuwej dnpcxpmbocxagwbskunvz dd Dt Bvflo Rsvxeop	Caen	France
Ctjnbh Hlvcvarddsi Uhtysplyklkzd Dv Dvfcl	Dijon	France
Aslecvjeab Puqcgwzh Hlwghjgm Dt Mmnlnxcjf	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	30.11.2020

Trial locations

Investigated drugs:

Dexamethasone

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.

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 ID:

2024-514362-39-00

Protocol code:

69HCL19_0588

NCT ID:

NCT04116398

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Dexamethasone Implant for Patients with Diabetic Macular Edema

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?