NCT01673191已完成2 期
A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean Change in Best Corrected Visual Acuity
研究概览
简要总结
There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.
详细描述
The objective of this study is to assess the safety and efficacy of the OZURDEX® intraocular implant in patients with diabetes mellitus, who develop macular edema after cataract surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Patient has diagnosis of Diabetes Mellitus, Type I or II.
- •Patient has experienced the development of macular edema following cataract surgery in at least one eye.
- •Patient has had cataract surgery within 90 days prior to the screening visit.
排除标准
- •Patient has other significant ocular disease in study eye, including glaucoma.
- •Patient has any active infection in the study eye.
- •Patient has uncontrolled systemic illness (i.e., uncontrolled blood pressure, uncontrolled diabetes mellitus).
- •Patient has experienced a significant increase in intraocular pressure following a prior treatment with topical or intravitreal steroidal medication.
- •Patient has received the OZURDEX® implant before in the study eye.
研究组 & 干预措施
OZURDEX intraocular implant
Experimental
OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg
干预措施: Dexamethasone intravitreal implant (Drug)
Steroid plus NSAID eye drop combination therapy
Active Comparator
NSAID eye drop: Acular LS Steriod eye drop: Pred Forte
干预措施: Steroid plus NSAID eye drop combination therapy (Drug)
结局指标
主要结局
Mean Change in Best Corrected Visual Acuity
时间窗: 3 months
Mean Change in Central Retinal Thickness
时间窗: 3 months
Mean Change in Intraocular Pressure
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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