NCT00993525Unknown1 期
INTRAVITREAL RANIBIZUMAB FOR PERSISTENT NEW VESSELS IN DIABETIC RETINOPATHY (INIPE STUDY)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 22
- 主要终点
- total area of fluorescein leakage from active new vessels
研究概览
简要总结
To evaluate the fluorescein angiographic and visual acuity effects of a single intravitreal injection of ranibizumab for the management of persistent new vessels associated with diabetic retinopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •persistent new vessels,defined as fine retinal vessels with dilated buds or tips covered with hemorrhage or associated with recurrent vitreous hemorrhage or paucity of accompanying fibrous tissue and/or increased in extent compared to previous visit,unresponsive to complete panretinal laser photocoagulation performed at least 4 months prior;
- •logarithm of minimum angle of resolution (logMAR) best-corrected visual acuity of 0.17 (Snellen equivalent, 20/30) or worse.
排除标准
- •history of vitrectomy in the study eye;
- •history of thromboembolic event (including myocardial infarction or cerebral vascular accident);
- •major surgery within the prior 6 months or planned within the next 28 days;
- •uncontrolled hypertension;
- •known coagulation abnormalities or current use of anticoagulative medication other than aspirin.
研究组 & 干预措施
Intravitreal anti-VEGF
Experimental
Intravitreal injection of 0.5 mg of ranibizumab
干预措施: Intravitreal injection of ranibizumab (Drug)
结局指标
主要结局
total area of fluorescein leakage from active new vessels
时间窗: baseline, weeks 1,6,12,24,36,48
Best corrected Visual Acuity (BCVA)
时间窗: Baseline, weeks 1,6,12,24,36,48
central macular thickness
时间窗: baseline, weeks 1,6,12,24,36,48
次要结局
未报告次要终点
研究者
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