NCT01662518已完成1 期
A Safety and Efficacy Study to Assess DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)
Centro de Pesquisa Rubens Siqueira1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone (DDS-25) for the treatment of macular edema associated with retinal vein occlusion.
详细描述
Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 10 patients with macular edema associated with retinal vein occlusion undergoing intravitreal injection of implant of dexamethasone (DDS-25).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older with macular edema resulting from retinal vein occlusion
- •Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
- •Visual acuity in other eye no worse than 20/200
排除标准
- •Known anticipated need for ocular surgery within next 12 months
- •History of glaucoma or current high eye pressure requiring more than 1 medication
- •Diabetic retinopathy
- •Uncontrolled systemic disease
- •Known steroid-responder
- •Use of systemic steroids
- •Use of warfarin/heparin
研究组 & 干预措施
DDS-25
Experimental
Intravitreal injection of DDS-25(Dexamethasone drug delivery system )
干预措施: Dexamethasone drug delivery system (DDS-25) (Device)
结局指标
主要结局
Best Corrected Visual Acuity (BCVA)
时间窗: Day 0 - Day 180
次要结局
- Change in central foveal thickness at 48 weeks(1 day to 48 weeks)
研究者
Rubens Camargo Siqueira
MD,PhD - Principal Investigator
Centro de Pesquisa Rubens Siqueira
研究点 (1)
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