Aflibercept Injection for Treatment of Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 8
- 主要终点
- Estimation of visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS)
研究概览
简要总结
This a non-interventional retrospective study on the efficiency and the tolerance of intravitreal injections of Aflibercept on vitrectomized eyes in the diabetic macular oedema
详细描述
Diabetic macular edema (DME) is the leading cause of blindness among people of working age. Treatment of DME included blood pressure and glycemic control, grid laser, intravitreal injection of steroids (acetonide of triamcinolone, dexamethasone implant, fluocinolone implant) or anti-Vascular endothelial growth factor (VEGF) therapy (Bevacizumab, Ranibizumab, Aflibercept) (2015). The advent of anti-VEGF therapy has revolutionized the management of DME. Aflibercept, one of the drugs in this group has recently been approved in France. However, there is no report in the efficacy and tolerance of Aflibercept in vitrectomized eyes in the diabetic macular oedema . In this study, in order to prove the efficiency and tolerance of Aflibercept, data will be collected in a anonymous way in medical records of patients having received a treatment by Aflibercept in the past.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic patients aged between 19 and 90 years old
- •Patients with the following characteristics at the beginning of the Aflibercept therapy :
- •HbA1c < 9% Diabetic macular oedema with the central affected Visual acuity between 1/20 and 5/40 (between 20 and 70 letters ETRS) Patients who had a vitrectomy over 3 months ago
- •Patients who did not received an anti-VEGF treatment or any other treatment for their diabetic macular edema 3 months before the beginning of the injections
排除标准
- •Patients who refused the collection of their data in medical records
- •Patients with a macular ischemia of more than 1500µm diagnosed via an avascular central fluorescein angiography before the inclusion
- •Patients with a recent cardiovascular incident (heart attack, stroke dating for less than 3 months before the inclusion)
- •Pregnancy at the moment of inclusion
结局指标
主要结局
Estimation of visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS)
时间窗: 96 weeks
Estimation of visual acuity after 96 weeks of treatment with Aflibercept
次要结局
- Measure of the central macular thickness(96 weeks)
- Quantification of number of Aflibercept injections received(96 weeks)