2024-513983-24-00RecruitingPhase 4
Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema
EMMA - Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To assess the cost-utility ratio at 3 years of treatment with fluocinolone acetonide (FA) intravitreal implant compared with treatment with dexamethasone (DXM) intravitreal implant in the treatment of resistant DME in pseudophakic patients, from a societal point of view
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- First submitted
- 21 May 2024
- Start date
- 29 Oct 2021
- Lead sponsor
- Centre Hospitalier Universitaire De Dijon
- Diseases
- Diabetic eye disease
- EU CT number
- 2024-513983-24-00
- EudraCT number
- 2020-005100-18
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 106
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- In the eye studied : - Patient who received an injection of Iluvien (fluocinolone acetonide) less than 24 months ago
- In the eye studied : Patients with ocular hypertonia > 21 mmHg despite treatment with more than 2 molecules
Other illness
- Patients with a known hypersensitivity to the active substance or to one of the excipients of Ozurdex® or Iluvien®
- 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
- In the eye studied : Aphakic patients or patients with a history of capsular rupture and wearing an iris-fixed or transcleral implant
Lab values
- Glycated haemoglobin > 12%.
Other
- Person who is not affiliated with the national health insurance system
- Patient unable to give consent
- Patients who have already participated in the study
- Patient for whom the follow-up required by the protocol is not feasible (moving house, etc.)
- In the eye studied : Patients with untreated severe proliferative or non-proliferative diabetic retinopathy
- In the eye studied : Patients who have undergone pan-retinal photocoagulation or focal treatment within the last 3 months
- In the eye studied : Patients with capillary macroaneurysms accessible to focal laser treatment
- In the eye studied : Phakic patients
- Person subject to a measure of legal protection or a court order
- Pregnant, parturient or breast-feeding women
Who the study is looking for
- Patients who have given their free, informed and written consent
- Patients aged 18 and over
- Patient with DME greater than 300 microns central foveolar thickness still present after at least 2 years of treatment and responsible for a drop in visual activity
- Patient who has had at least one anatomically and functionally effective DXM injection for more than 4 months
- Patient who has had an anti-VEGF injection for more than 3 months
- Pseudophakic patient with surgery more than 6 months ago
- Patients with uni- or bilateral diabetic macular oedema (in the case of bilateral diabetic macular oedema, the most affected eye will be included in the study)
- Best Corrected Visual acuity (BCVA) ≤ 80 letters ETDRS
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Intercommunal Créteil | Créteil | France | Recruiting |
| Centre Hospitalier Universitaire de Dijon | Dijon | France | Recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes | La Tronche | France | Recruiting |
| Hospices Civils De Lyon | Lyon Cedex 03 | France | Recruiting |
| Hospices Civils De Lyon | Lyon Cedex 04 | France | Recruiting |
| Centre Monticelli Paradis d'Ophtalmologie | Marseille | France | Recruiting |
| Clinique Honoré Cave | Montauban | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes | Nantes | France | Recruiting |
| Centre Hospitalier Universitaire de Nice | Nice | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Paris Cedex 10 | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | France | Recruiting |
| CHRU De Nancy | Vandoeuvre Les Nancy | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.