NCT02131350已完成4 期
Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- best corrected visual acuity
研究概览
简要总结
The purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (IVR) injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable photocoagulation decreases the number of IVR injections.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stable medication for the management of diabetes within 3 months
- •visual impairment due to focal or diffuse diabetic macula edema
- •decreased vision due to diabetic macula edema and not other causes
排除标准
- •concomitant conditions in the study eye that could prevent the improvement in VA on the study
- •active intraocular inflammation or infection in either eye
- •uncontrolled glaucoma in either eye
- •treatment with antiangiogenic drugs in the study eye within 3 months
- •history of stroke and uncontrolled hypertension
研究组 & 干预措施
Ranibizumab with Photocoagulation
Experimental
干预措施: Photocoagulation (Procedure)
Ranibizumab with Photocoagulation
Experimental
干预措施: Ranibizumab (Drug)
结局指标
主要结局
best corrected visual acuity
时间窗: every month, up to 36 months
Best corrected visual acuity is measured with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and analysed.
次要结局
未报告次要终点
研究者
Takao Hirano
Department of Ophthalmology Shinshu University School of Medicine
Shinshu University
研究点 (1)
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