2024-513983-24-00招募中4 期
EMMA - Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 11
- 主要终点
- Incremental cost-utility ratio at 3 years, from a societal point of view, expressed in terms of cost per year of life gained in good health (cost/QALY).
研究概览
简要总结
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
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incremental cost-utility ratio at 3 years, from a societal point of view, expressed in terms of cost per year of life gained in good health (cost/QALY).
Incremental cost-utility ratio at 3 years, from a societal point of view, expressed in terms of cost per year of life gained in good health (cost/QALY).
次要结局
- BCVA measured using the ETDRS at each follow-up visit (including inclusion): Construction of the average variation using the AUC approach over the 0-12 month, 0-24 month and 0-36 month periods
- BCVA measured using the ETDRS at each follow-up visit (including inclusion): Construction of the difference between inclusion and 12, 24 and 36 months
- BCVA measured using the ETDRS at each follow-up visit (including inclusion): Construction of the gain ≥15 letters (yes/no) variable at 12, 24 and 36 months compared with inclusion
- BCVA measured using the ETDRS at each follow-up visit (including inclusion): Construction of the "BCVA involvement" ≥80 letters (yes/no) variable at 12, 24 and 36 months compared with inclusion
- Central retinal thickness, measured as the central foveolar thickness by optical coherence tomography at inclusion, 12, 24, and 36 months: construction of the difference between inclusion and 12, 24 and 36 months
- Treatment regimen (number of injections and time to re-injection)
- Additional ophthalmological treatments and visits compared with conventional follow-up.
- VFQ-25 quality of life scores at baseline and at 12, 24 and 36 months
- Adverse events (ocular hypertonia with initiation of a new treatment or filtering surgery, endophthalmitis, retinal detachment, etc.) at 12, 24 and 36 months.
- Incremental cost-effectiveness ratio at 3 years expressed in terms of cost per life-year gained, then in terms of cost per case of visual impairment avoided (visual impairment being defined by a result of 4/10ths, i.e. 65 letters ETDRS) and finally in terms of cost per case of legal blindness avoided (blindness being defined by a BCVA ≤ 1/20th, i.e. 20 letters ETDRS)
- Net financial impact of widespread use of the FA implant on the compulsory health insurance budget: costs incurred, costs avoided.
研究者
Chef de Projets Recherche
Scientific
Centre Hospitalier Universitaire De Dijon
研究点 (11)
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