NCT01411254已完成2 期
A Randomized, Multicenter, Sham Controlled, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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 efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provided signed, written informed consent
- •20 years of age or older with diabetic macular edema
排除标准
- •Active proliferative diabetic retinopathies (PDR) in the study eye
- •Uncontrolled diabetes mellitus and hypertension
- •Known steroid-responder
研究组 & 干预措施
1
Experimental
干预措施: Betamethasone Microsphere (DE-102） Low Dose (Drug)
2
Experimental
干预措施: Betamethasone Microsphere (DE-102） High Dose (Drug)
3
Sham Comparator
干预措施: Sham (Drug)
结局指标
主要结局
Best Corrected Visual Acuity(BCVA)
Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score
次要结局
- retinal thickness
研究者
研究点 (1)
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