Medico-economic Evaluation of Anti-VEGF Treatments in the Treatment of naïve Age-related Macular Degeneration (AMD): a Model Adapted to the French Context
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Cost-utility analysis of the modalities of management of neovascular age-related macular degeneration
研究概览
简要总结
Age-related macular degeneration (AMD) is the leading cause of blindness after 50 years in industrialized countries, compromising daily activities and reducing quality of life. And whose treatment is one of the first health expenditures. Since September 2015, Bevacizumab, which does not have marketing authorization in AMD, has been given a temporary recommendation for use. Studies in other countries have shown that bevacizumab is cost-effective in the treatment of AMD compared to other anti-VEGF therapies used.
详细描述
Numerous clinical trials have shown the effectiveness of Bevacizumab in the treatment of neovascular AMD as well that non-inferiority compared to Ranibizumab in terms of clinical efficacy at 1 year on visual acuity measured by the ETDRS scale of patients with neovascular AMD.
Regarding general tolerance, a recent meta-analysis including a large number of patients did not find any difference in systemic serious adverse reactions, neither any new special signal of tolerance with Bevacizumab. Concerning eye tolerance, there is no evidence of difference significant. Medico-economic analyzes carried out in other countries, as the United States or Brazil, have shown that Bevacizumab is cost-effective compared to Ranibizumab in AMD Neovascular.
The cost-utility analysis of the different methods of care patients with AMD will rely on the construction of a self-centered model built from: data available in natural history literature AMD in the absence of treatment; results of the network meta-analysis comparing effectiveness and tolerance of different strategies to assess; available data on adherence and persistence of treatments; pharmacovigilance data on the occurrence of side effects.
This analysis benefits from two related studies:
- Micro-costing, multicenter study of the preparation of intravitreal injections of Bevacizumab hospital pharmacy.
- Multicenter, prospective evaluation, cross-section, quality of life data and patient cost depending on the level of visual acuity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Naive neovascular AMD form of retro localization foveal, unilateral or bilateral (one eye per patient will be studied),
- •Patients to be treated with intravitreous injections of Bevacizumab or Ranibizumab or Aflibercept,
- •Patient using effective contraception if he is of childbearing age
- •Patient informed and not having made his opposition to the research,
- •Patient under social security scheme.
排除标准
- •Previous or current treatment of AMD by intravenous injection of anti-VEGF or surgery dating less than 2 months in the studied eye,
- •Contraindications to the taking of Bevacizumab or Ranibizumab or Aflibercept,
- •Aphakia in the studied eye,
- •Fibrosis or retrofoveolar retinal atrophy of the eye studied,
- •Tearing of the pigment epithelium reaching my macula of the studied eye,
- •Choroidal neovascularization unrelated to AMD,
- •Diabetic retinopathy and / or diabetic maculopathy proven,
- •Glycated hemoglobin greater than 12%,
- •Known hypersensitivity to pharmaceutical agents used,
- •Pregnant or lactating women,
- •Severe active intraocular inflammation, or history autoimmune or idiopathic uveitis,
- •Active or suspected ocular or periocular infection,
- •Intraocular pressure> 25mmHg despite two hypotonizing treatments in eye drops,
- •Patient under tutorship or curatorship or private public law.
结局指标
主要结局
Cost-utility analysis of the modalities of management of neovascular age-related macular degeneration
时间窗: 12 months
Using a probabilistic Markov model
次要结局
- Quality of life coefficient: HUI 3 questionnaire(12 months)
- Micro-costing type evaluation of packaging of Intravitreal injections of Bevacizumab in pharmacy hospital.(12 months)