NCT04910503RecruitingPhase 4
Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema
Source: ClinicalTrials.gov · Last updated 9 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- First submitted
- 27 May 2021
- Start date
- 29 Oct 2021
- Primary completion date
- Apr 2030
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Diseases
- Diabetic eye disease
- NCT number
- NCT04910503
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 106
- From 29 Oct 2021 to the primary completion date, Apr 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient who received an injection of Iluvien (fluocinolone acetonide) less than 24 months ago-
Other illness
- 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
Lab values
- Glycated hemoglobin \> 12%.
- In the study eye:
Age
- Patient of full age who is unable to give consent;
Other
- 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
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Dijon Bourgogne Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.