Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema

Phase 4

Recruiting

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Dexamethasone intravitreal implant; Drug: Fluocinolone Acetonide Intravitreal Implant

• Registration Number: NCT04910503
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

Diabetic macular oedema (DME) is the main cause of visual impairment (or visual acuity) in patients with diabetic retinopathy, as it leads to progressive thickening of the retina, which in the long term leads to progressive death of the photoreceptor cells. It is therefore important to continue to treat macular oedema that has been progressing for several months or even years (resistant DME).

The management of DME necessarily involves controlling diabetes (improving glycated haemoglobin levels) and blood pressure, but this is often not enough.

Thus, when DME is significant and leads to a decrease in visual acuity, treatments are administered directly into the eye (intravitreal injections). For some years now, corticosteroids have been injected into the vitreous body (the gel that fills the eyeball) through the white of the eye for their anti-inflammatory properties. Indeed, these drugs improve the permeability of the retinal vessels and thus reduce oedema. These intravitreal implants are most often used in patients who have already undergone cataract surgery (pseudophakic) because corticosteroids also tend to aggravate a cataract. Currently, there are two implants containing corticosteroids that can be injected: the dexamethasone implant and the fluocinolone acetonide implant. These two implants have different properties, particularly with regard to their duration of action.

Today, the overall management at 3 years and the quality of life associated with the treatments deserve to be evaluated.

This study is the first multicenter controlled trial comparing the two reference corticosteroid treatments in terms of overall cost of treatment and follow-up and patient quality of life, while considering their efficacy and side effects. This evaluation will make it possible to precisely define the respective place of each implant in the management of resistant DME.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-06-02
• Study Start: 2021-10-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2030-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual strategy	Dexamethasone intravitreal implant	-
Innovative strategy	Fluocinolone Acetonide Intravitreal Implant	-

Primary Outcome Measures

Name	Time	Method
Cost per healthy year gained	3 years after starting treatment

Trial Locations

Locations (1)

CHU Dijon-Bourgogne; 🇫🇷 Dijon, France