Retrospective Data Collection Study in Patients With Macular Oedema Receiving OZURDEX®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 43
- 主要终点
- Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
研究概览
简要总结
This study will use retrospective data to evaluate the safety and efficacy of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) in the treatment of macular oedema due to retinal vein occlusion (RVO) in clinical practice. No intervention will be administered as part of this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central vein occlusion (CRVO)
- •Received at least one injection of OZURDEX® in the study eye
排除标准
- 未提供
结局指标
主要结局
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
时间窗: Baseline, 7 to 12 weeks following the first OZURDEX® injection
BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart. The number of letters read correctly Snellen fraction are converted to a decimal scale. There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best. 20/20 on the decimal scale is equal to 1.0. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved.
次要结局
- Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye(Baseline, Up to 17 Months)
- Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye(Baseline, Up to 17 Months)
- Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)(Baseline, 7 to 12 weeks following the first OZURDEX® injection)
- Time to Improvement of 2 Lines or More in BCVA in the Study Eye(Baseline, Up to 17 Months)
- Time to Improvement of 3 Lines or More in BCVA in the Study Eye(Baseline, Up to 17 Months)
- Time to OZURDEX® Re-Injection in the Study Eye(Up to 17 Months)