Retrospective Study in Patients Receiving Two or More OZURDEX® Injections for Retinal Vein Occlusion (RVO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 289
- 主要终点
- Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection
研究概览
简要总结
This is a retrospective data collection study to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular edema due to RVO. Following informed consent, there were no patient study visits. All data was collected via chart review.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Macular edema
- •Received at least 2 OZURDEX® injections
排除标准
- •Received OZURDEX® injections as part of a clinical study
研究组 & 干预措施
All Participants
Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
干预措施: dexamethasone intravitreal implant 0.7 mg (Drug)
结局指标
主要结局
Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection
时间窗: Baseline, 4 to 20 weeks after last injection (Up to 6 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 change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement.
次要结局
- Percentage of Participants With an Increase of 2 Lines or More in BCVA(Baseline, Up to 6 months)
- Percentage of Participants With an Increase of 3 Lines or More in BCVA(Baseline, Up to 6 months)
- Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection(Baseline, 4 to 20 Weeks after Each injection (up to 6 months))