NCT01518842Unknown不适用
Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in size of FAZ at 48 weeks
研究概览
简要总结
This study aims to evaluate the behavior of the intravitreal use of bone marrow derived stem cells in patients with ischemic retinopathy.
详细描述
Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 30 patients with ischemic retinopathy, including diabetic retinopathy with severe loss of retinal capillaries undergoing intravitreal injection of bone marrow derived stem cells.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Ischemic Retinopathy
- •Enlargement of foveal avascular zone-FAZ (ischaemia or capillary drop out of >30% on Fluorescein retinography
- •logarithm of minimum angle of resolution (logMAR) BCVA of 1.0 (Snellen equivalent, 20/200) or worse
- •Able (in the Investigator's opinion) and willing to comply with all study requirements
排除标准
- •previous ocular surgery other than cataract
- •presence of cataract or other media opacity that would influence ocular fundus documentation and adequate ERG and visual field evaluation
- •other ophthalmic disease like glaucoma and uveitis
- •previous history of blood disorders like leukemia
- •known allergy to fluorescein or indocyanine green
结局指标
主要结局
Change in size of FAZ at 48 weeks
时间窗: 1 day to 48 weeks
次要结局
- Change in central foveal thickness and best corrected visual acuity at 48 weeks(1 day to 48 weeks)
研究者
Rubens Camargo Siqueira
MD,PhD - Principal Investigator
University of Sao Paulo
研究点 (2)
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