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Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema
EU CTIS ID: 2024-513983-24-00
What this study is testing
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
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Person who is not affiliated with the national health insurance system
- Patient unable to give consent
- Patients with a known hypersensitivity to the active substance or to one of the excipients of Ozurdex® or Iluvien®
- Patients who have already participated in the study
- Patient for whom the follow-up required by the protocol is not feasible (moving house, etc.)
- 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
See the full eligibility criteria
- 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
- Person who is not affiliated with the national health insurance system
- Patient unable to give consent
- Patients with a known hypersensitivity to the active substance or to one of the excipients of Ozurdex® or Iluvien®
- Patients who have already participated in the study
- Patient for whom the follow-up required by the protocol is not feasible (moving house, etc.)
- 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
- Glycated haemoglobin > 12%.
- In the eye studied : - Patient who received an injection of Iluvien (fluocinolone acetonide) less than 24 months ago
- 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 : Patients with ocular hypertonia > 21 mmHg despite treatment with more than 2 molecules
- In the eye studied : Aphakic patients or patients with a history of capsular rupture and wearing an iris-fixed or transcleral implant
- In the eye studied : Phakic patients
- Person subject to a measure of legal protection or a court order
- Pregnant, parturient or breast-feeding women
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.