One Year Results of Switching to Aflibercept for Persistent Diabetic Macular Edema Resistant to Bevacizumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- central macular thickness after one year
研究概览
简要总结
Purpose: The aim of this study is to evaluate the functional and anatomical effects of switching from Bevacizumab to Aflibercept in patients with persistent DME resistant to Bevacizumab.
Methods: Patients with DME refractory to Bevacizumab (1.25 mg/ 0.05 mL) were subsequently switched to Aflibercept (2.0 mg/0.05 ml). The included patients received 5 loading doses of intravitreal Aflibercept (2.0 mg/0.05 mL) (Eylea; Bayer, Berlin, Germany) given monthly. After the loading dose, Aflibercept was injected every 2 months. The follow up duration was one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetic patients, older than 18years,
- •center-involving DME, central macular thickness (CMT) >300 μm by spectral domain optical coherence tomography (SD-OCT) 1 month after the last Bevacizumab injection.
- •The best corrected visual acuity must be better than 0.05 decimal visual acuity (1.3 log MAR). Only one eye from each patient was included in the study. If both eyes met the inclusion criteria, the eye with worse visual acuity was included.
排除标准
- •Patients were excluded if they had dense media opacity, pregnancy, previous intravitreal steroid therapy.
- •uncontrolled diabetes mellitus (HbA1c ≥ 10%) and prior intraocular surgery (with the exception of uneventful cataract surgery >6 months prior to conversion).
- •Other exclusion criteria included active proliferative diabetic retinopathy, tractional maculopathy, macular ischemia and other ocular diseases: age-related macular degeneration, central/branch retinal vein occlusion, and glaucoma.
研究组 & 干预措施
Diabetic macular edema resistant to Bevacizumab
Patients resistant to 6 monthly Bevacizumab injection were switched to Aflibercept.
干预措施: Aflibercept Injection [Eylea] (Drug)
结局指标
主要结局
central macular thickness after one year
时间窗: 12 months
Optical Coherence Tomography changes after 12 months.
次要结局
未报告次要终点
研究者
Mahmoud Abouhussein
Assistant professor
University of Alexandria