NCT03097068已完成4 期
Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis
Vitreo-Retinal Associates, Michigan1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年4月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Vascular Endothelial Growth Factor Levels
研究概览
简要总结
The protocol will measure a number of cytokines in addition to vascular endothelial growth factor in response to 0.3mg Lucentis.
详细描述
Lucentis injections are the current standard of care for diabetic macular edema. The only deviation from the standard of care in the current protocol is an aqueous tap before the first Lucentis injection and the fourth Lucentis injection for diabetic macular edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Diagnosis of diabetes mellitus
- •Best corrected visual acuity 20/32 - 20/320
- •Diabetic macular edema involving the center of the macula
- •Optical coherence tomography central subfield thickness of at least 250 microns
排除标准
- •History of anti-vascular endothelial growth factor treatment in the past 12 months
- •Any diabetic macular edema treatment in the past 4 months
- •Heart attack, stroke, transient ischemic attack or acute congestive heart failure within 4 months
研究组 & 干预措施
0.3 mg Lucentis
Experimental
Aqueous Humor sample post injection of 0.3 mg Lucentis
干预措施: Lucentis (Drug)
结局指标
主要结局
Vascular Endothelial Growth Factor Levels
时间窗: 12 weeks
An aqueous humor specimen was obtained at baseline and at 12 weeks to determine if the levels of VEGF had decreased with treatment.
次要结局
未报告次要终点
研究者
Louis C Glazer, MD
Principal Investigator
Vitreo-Retinal Associates, Michigan
研究点 (1)
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