Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema
Key facts
- Where
- Créteil, Dijon, La Tronche, Lyon Cedex 03, Lyon Cedex 04, Marseille, Montauban, Nantes, Nice, Paris Cedex 10, Poitiers és Vandoeuvre Les Nancy, FranciaországSee the 12 sites
- Phase
- 4. fázis
Where in Franciaország
- Centre Hospitalier Intercommunal CréteilCréteil, FranciaországTaking people
- Centre Hospitalier Universitaire de DijonDijon, FranciaországTaking people
- Centre Hospitalier Universitaire Grenoble AlpesLa Tronche, FranciaországTaking people
- Hospices Civils De LyonLyon Cedex 03, FranciaországTaking people
- Hospices Civils De LyonLyon Cedex 04, FranciaországTaking people
- Centre Monticelli Paradis d'OphtalmologieMarseille, FranciaországTaking people
- Clinique Honoré CaveMontauban, FranciaországTaking people
- Centre Hospitalier Universitaire de NantesNantes, FranciaországTaking people
- Centre Hospitalier Universitaire de NiceNice, FranciaországTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 10, FranciaországTaking people
- Centre Hospitalier Universitaire de PoitiersPoitiers, FranciaországTaking people
- CHRU De NancyVandoeuvre Les Nancy, FranciaországTaking people
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?
Trial details
- Who runs it
- Centre Hospitalier Universitaire De Dijon
- Trial code
- EU 2024-513983-24-00
- Record updated
- 2025. április 30.
- Original description
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 viewRead full original descriptionShow less
EMMA - Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema
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
Inclusion: 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.
Exclusion: 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; 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; Glycated haemoglobin > 12%; 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.