Under construction – not a live service
Sign in

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

Next steps

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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (12)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Intercommunal CréteilCréteilFranceRecruiting
Centre Hospitalier Universitaire de DijonDijonFranceRecruiting
Centre Hospitalier Universitaire Grenoble AlpesLa TroncheFranceRecruiting
Hospices Civils De LyonLyon Cedex 03FranceRecruiting
Hospices Civils De LyonLyon Cedex 04FranceRecruiting
Centre Monticelli Paradis d'OphtalmologieMarseilleFranceRecruiting
Clinique Honoré CaveMontaubanFranceRecruiting
Centre Hospitalier Universitaire de NantesNantesFranceRecruiting
Centre Hospitalier Universitaire de NiceNiceFranceRecruiting
Assistance Publique Hopitaux De ParisParis Cedex 10FranceRecruiting
Centre Hospitalier Universitaire de PoitiersPoitiersFranceRecruiting
CHRU De NancyVandoeuvre Les NancyFranceRecruiting

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.