Compares two steroid eye implants for hard-to-treat diabetic macular swelling
Compares two steroid implants in adults with long-lasting diabetic swelling of the retina.
Key facts
- Who runs it
- Centre Hospitalier Universitaire Dijon
- Where
- Dijon, FranceSee the site
- Trial code
- Registry title
- Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 106 people, planned
- Started
- 29 Oct 2021
- Expected to end
- Apr 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Dexamethasone intravitreal implant
- Fluocinolone Acetonide Intravitreal Implant
- Record updated
- 9 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with diabetic macular oedema that has not improved after at least 2 years of treatment, who have had cataract surgery and earlier eye injections.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Diabetic macular oedema with retina thickness greater than 300 microns at the centre of the retina, still present after at least 2 years of treatment, and lowering vision (BCVA 80 letters ETDRS or fewer).
- Earlier treatment
- Must have had at least one effective dexamethasone injection more than 5 months ago and one anti-VEGF injection more than 3 months ago. Cataract surgery (pseudophakic) must be more than 6 months ago.
Main reasons for not taking part
- Pregnant, giving birth or breast-feeding women
- Uveitis, glaucoma or eye infection, or allergy to the implant drugs
- Iluvien injection less than 24 months ago
- Glycated haemoglobin above 12% (108 mmol/mol)
- Still has the natural lens (phakic) or has no lens (aphakic) in the study eye
The registry criteria, word for word
Show all 24 criteriaShow less
Who can take part
- Patient who has given free, written and informed consent
- Major patient
- Patient with treated DME greater than 300 microns of central foveolar thickness still present after at least 2 years of treatment and responsible for a decrease in visual activity
- Best corrected Visual acuity (BCVA) ≤ 80 letters ETDRS
- Patient who has received at least one anatomically and functionally effective dexamethasone (DXM) injection more than 5 months ago
- Patient who has received one anti-VEGF injection more than 3 months ago
- Pseudophakic patient with surgery older than 6 months
- Patient with uni or bilateral diabetic macular oedema (in the case of bilateral diabetic macular oedema, the most affected eye will be treated)
Who cannot take part
- Patient who received an injection of Iluvien (fluocinolone acetonide) less than 24 months ago-
- Patients with a known hypersensitivity to the active substance or to one of the excipients of Ozurdex®, Iluvien® ; Patients with uveitis or a severe form of asthma
- Patients with pre-existing uveitis or glaucoma or active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and mycoses
- Aphakic patients or patients with a history of capsule rupture and iridal or transcleral fixation implants
- Glycated hemoglobin > 12%; In the study eye:
- Patient of full age who is unable to give consent
- Patient not covered by national health insurance
- Patient under a measure of legal protection
- Pregnant, parturient or breast-feeding woman
- Patient who has already participated in the study
- Patient for whom the follow-up imposed by the protocol is not feasible (relocation)
- Patient with untreated severe proliferative or non-proliferative diabetic retinopathy
- Patient with pan-retinal photocoagulation or focal treatment less than 3 months old
- Patient with capillary macro aneurysms accessible to focal laser
- Patient with ocular hypertonia > 21 mmHg despite a treatment of more than 2 molecules
- Phakic patient
Where in France
- Chu Dijon BourgogneDijon, FranceContact: Catherine CREUZOT-GARCHERTaking people
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
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.
The 2 groups in the trial
- Usual strategyExisting treatment, for comparison
Treatment: Dexamethasone intravitreal implant
- Innovative strategyTreatment being tested
Treatment: Fluocinolone Acetonide Intravitreal Implant
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema
- Plain-language title
- Compares two steroid eye implants for hard-to-treat diabetic macular swellingGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 9 May 2025