NCT01512901已完成2 期
A Randomized, Sham Controlled, Multicenter, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion
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
- Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score
研究概览
简要总结
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for macular edema following branch retinal vein occlusion
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
- •20 years of age or older
- •Diagnosis of macular edema following branch retinal vein occlusion
排除标准
- •BCVA ETDRS letter score in non-study eye < 35
- •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
Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score
次要结局
- Change in retinal thickness from baseline
研究者
研究点 (1)
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