Aflibercept Plus Micropulse Laser Versus Aflibercept Monotherapy for Diabetic Macular Edema. One Year Results of a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- The number of Aflibercept injections in both groups
研究概览
简要总结
Purpose: To evaluate the role of adjuvent micropulse laser with Aflibercept injections in the management of treatment naïve centre involving DME, looking at decreased treatment burden and increased efficacy as outcomes.
Methods: This was a prospective, single centre, randomized trial that included 40 eyes (40 patients) with previously untreated centre involved DME. Patients were randomly assigned to receive either Aflibercept plus micropulse laser (group A) or Aflibercept monotherapy (group B).
详细描述
Patients were randomly distributed in a 1:1 ratio between the two studied groups. Group A received 3 monthly injections of Aflibercept 2 mg/0.05 mL (Eylea; Bayer, Berlin, Germany) as a loading dose, followed one month later by one 577 nm yellow micropulse laser session with monthly PRN Aflibercept injections. Group B received 3 monthly injections of Aflibercept 2 mg/0.05 mL as a loading dose, followed by monthly PRN Aflibercept injections. Patients in both groups were assessed one month after the end of loading phase; At this point, group A received the micropulse laser session and started PRN Aflibercept injections, while group B started PRN Aflibercept injections without receiving the micropulse laser session. After that, both groups were followed for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •patients were older than 18 with the clinical diagnosis of previously untreated centre involved DME documented by fluorescein angiography and central macular thickness (CMT) ≥ 300 µm on the spectral-domain OCT Best corrected visual acuity was better than 3/60 with Hb A1C less than 10%.
排除标准
- •any previous treatment for DME, proliferative diabetic retinopathy, macular ischemia on fluorescein angiography, epiretinal membrane or tractional maculopathy on OCT, media opacity and any previous intraocular surgery with the exception of uneventful cataract surgery more than 6 months before the beginning of the study.
研究组 & 干预措施
Aflibercept plus micropulse laser (group A)
Overall 40 patients were included in the study; they were randomized into either group A (Aflibercept + Micropulse; 20 patients) or group B (Aflibercept monotherapy; 20 patients).
干预措施: micropulse laser (Device)
Aflibercept plus micropulse laser (group A)
Overall 40 patients were included in the study; they were randomized into either group A (Aflibercept + Micropulse; 20 patients) or group B (Aflibercept monotherapy; 20 patients).
干预措施: Aflibercept (Drug)
Aflibercept monotherapy (group B)
Overall 40 patients were included in the study; they were randomized into either group A (Aflibercept + Micropulse; 20 patients) or group B (Aflibercept monotherapy; 20 patients).
干预措施: Aflibercept (Drug)
结局指标
主要结局
The number of Aflibercept injections in both groups
时间窗: 12 months
The number of Aflibercept injections in both groups
次要结局
- The changes in visual acuity in both groups.(12 months)
- The changes in central macular thickness in both groups.(12 months)
研究者
Mahmoud Abouhussein
Assistant professor
University of Alexandria