A Retrospective Chart Review of OZURDEX® in Patients With Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 101
- 主要终点
- Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
This retrospective chart review study will describe the history of patients with retinal disease with macular edema to whom OZURDEX® (dexamethasone intravitreal implant) is administered, and assess treatment patterns and visual outcomes. OZURDEX® was previously administered according to general clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retinal disease involving macular edema
- •Received at least one OZURDEX® injection
排除标准
- 未提供
研究组 & 干预措施
All Participants
Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
干预措施: Dexamethasone Intravitreal Implant (Drug)
结局指标
主要结局
Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
时间窗: Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months)
BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement.
次要结局
- Peak Mean Change From Baseline in Central Retinal Thickness (CRT)(Baseline, 2 to 26 weeks following last injection (up to 6.5 months))