NCT01473251已完成不适用
Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration
Vitreo-Retinal Associates, Michigan1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Analysis of collected vitreous samples to identify biomarkers.
研究概览
简要总结
The purpose of this study is to measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 18 to 85 with diabetes and hemoglobin A1C </= 10, or exudative macular degeneration.
- •Diabetic macular edema with average retinal thickness central subfield >/= 290um.
排除标准
- •Macular atrophy/fibrosis.
- •Ocular anti-VEGF treatment within 3 months.
- •Treatment with topical or oral carbonic-anhydrase inhibitor within one month
- •Laser photocoagulation within 3 months (diabetic cohort)
研究组 & 干预措施
Avastin for Diabetic Macular Edema
Active Comparator
1.25 mg avastin monthly for 4 months
干预措施: Avastin (Drug)
Avastin for Exudative Macular Degeneration
Active Comparator
1.25 mg Avastin monthly for 4 months
干预措施: Avastin (Drug)
Lucentis for Exudative Macular Degeneration
Active Comparator
0.5 mg Lucentis monthly for 4 months
干预措施: Lucentis (Drug)
结局指标
主要结局
Analysis of collected vitreous samples to identify biomarkers.
时间窗: End of study
Analysis of collected vitreous samples in regards to identification of biomarkers that are prognostic for response to anti-angiogenic treatment of retinopathy, and the exploration of a more effective dosing regiment for intravitreal injections of Lucentis/Avastin for exudative macular degeneration and Avastin for diabetic macular edema.
次要结局
未报告次要终点
研究者
研究点 (1)
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