NCT01422018Unknown不适用
Effect of Intravitreal Bevacizumab on Focal Edema With Hard Exudates Secondary to Diabetic Retinopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in best-corrected visual acuity (BCVA)
研究概览
简要总结
Purpose: To evaluate the efficacy of intravitreal bevacizumab (IVB) on focal edema with hard exudates secondary to diabetic retinopathy.
Design: Prospective interventional case series. Participants: Ten eyes of 10 consecutive patients showing focal edema with hard exudates secondary to diabetic retinopathy which are not eligible for focal laser photocoagulation due to central location (< 500 µm from fovea).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients of either gender aged > 18 years
- •patients with type 2 diabetes
- •central macular thickness > 300 µm on OCT
- •eyes not eligible for focal laser photocoagulation due to the central location of hard exudates (< 500 µm)
- •an area of retinal thickening less than 2 disc areas in diameter
- •67% or more of leakage associated with microaneurysms
排除标准
- •eyes with history of laser photocoagulation or pharmacological intervention for DME on study eye
- •eyes with any pharmacologic intervention on fellow eye within 6 months
- •history of ocular diseases other than diabetic retinopathy
- •surgical history other than cataract extraction with intraocular lens implantation
- •panretinal photocoagulation within 3 months of enrollment
- •media opacity
- •any thromboembolic event within 6 months, or evidence of active cardiac ischemia on electrocardiogram (ECG) at time of screening.
研究组 & 干预措施
one arm for Anastin injection
Experimental
intravitreal Avastin injection
干预措施: Avastin (bevacizumab) (Drug)
结局指标
主要结局
Changes in best-corrected visual acuity (BCVA)
时间窗: from month 0 to month 6 in monthly schedule (upto 6 months)
ETDRS BCVA will be measured after 6 6 serial IVB.
次要结局
- amount of hard exudates detected on fundus photography(from month 0 to month 6 in bimonthly schedule (upto 6 months))
- macular edema detected by optical coherent tomography(from month 0 to month 6 in bimonthly schedule (upto 6 months))
研究者
Won Ki Lee
Pf.
Seoul St. Mary's Hospital
研究点 (1)
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