Acute Changes in Intraocular Cytokines After Intravitreal Bevacizumab
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- intraocular VEGF levels (pg/ml) in both groups (measured in aqueous humor), using multiplex beads immunoassay
研究概览
简要总结
Purpose: To evaluate the acute changes in intraocular cytokines after intravitreal bevacizumab (IVB) in proliferative diabetic retinopathy.
Design: Prospective, open-label, controlled, randomized interventional clinical trial.
Participants: Twenty eyes of 28 consecutive patients who are scheduled for pars plana vitrectomy (ppV) for proliferative diabetic retinopathy were prospectively enrolled.
Methods: All patients were randomly assigned to receive IVB either at 2 or 7 days before ppV. Aqueous humor samples were taken from anterior chamber just before IVB and at the time of surgery. Multiplex cytokine array were used to assay various cytokines
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with proliferative diabetic retinopathy who were scheduled for PPV for vitreous hemorrhage or tractional retinal detachment (TRD)
排除标准
- •Eyes with any pharmacologic intervention on study eye within 6 months
- •Eyes with panretinal photocoagulation on study eye within 3 months
- •Eyes with any pharmacologic intervention on fellow eye within 3 months,
- •History of ocular diseases other than diabetic retinopathy
- •History of PPV on study eye
- •History of systemic thromboembolic events including myocardial infarction and cerebrovascular accidents.
研究组 & 干预措施
Intravitreal Avastin Day 2
randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B).
干预措施: Intravitreal Avastin injection (Drug)
Intravitreal Avastin Day 7
randomized to either treatment with preoperative IVB 2 days before PPV (Group A) or 7 days before PPV (Group B).
干预措施: Intravitreal Avastin injection (Drug)
结局指标
主要结局
intraocular VEGF levels (pg/ml) in both groups (measured in aqueous humor), using multiplex beads immunoassay
时间窗: At day 2 after IVB in Group 1, day 7 after IVB at group 2.
Because we want to compare the differences between day 2 and day 7, vitrectomy will be performed at day 2 in group 1 and day 7 in group 2. That's why the time frame has two time point
次要结局
未报告次要终点
研究者
Won Ki Lee
Preofessor
Seoul St. Mary's Hospital