NCT01284478已完成2 期
Phase 2 Study of Ozurdex for Combined Pseudophakic Cystoid Macula Edema and Diabetic Macula Edema After Cataract Surgery
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
- 6
- 试验地点
- 1
- 主要终点
- BEST CORRECTED VISUAL ACUITY (ETDRS)
研究概览
简要总结
The purpose of the study is to determine where a sustained steroid delivery system (Ozurdex,Allergan) is safe and effective to treat Cystoid Macular Edema in diabetic patients after Cataract Surgery
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
- 是
入选标准
- •DIABETIC PATIENTS WHO DEVELOP CYSTOID MACULA EDEMA AFTER CATARACT SURGERY (WITHIN 4-10 WEEKS AFTER SURGERY
- •VISUAL ACUITY WORSE THAN 20/32
排除标准
- •VISUAL ACUITY WORSE THAN 20/200
- •MODERATE OR SEVERE GLAUCOMA (AS DEFINED AS USING >2 TOPICAL GLAUCOMA MEDIATIONS.
- •USE OF SYSTEMIC, PERIOCULAR OR INTRAOCULAR CORTICOSTEROIDS WITHIN 30 DAYS OF ENROLLMENT
研究组 & 干预措施
Dexamethasone Implant
Other
Patients will be treated with the Ozurdex (Dexamethasone Implant)
干预措施: Dexamethasone Implant (Drug)
结局指标
主要结局
BEST CORRECTED VISUAL ACUITY (ETDRS)
时间窗: AT DAY 180
次要结局
- RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY(90 and 180 DAYS)
研究者
研究点 (1)
Loading locations...
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