Study of Ozurdex® Treatment Practice in Patients With Macular Oedema Due to Retinal Vein Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 375
- 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
Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 oedema due to retinal vein occlusion
排除标准
- •Not living in metropolitan France
研究组 & 干预措施
Ozurdex® (dexamethasone intravitreal implant)
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
干预措施: dexamethasone intravitreal implant (Drug)
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, Month 6
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.
次要结局
- Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO)(Baseline, Month 6)
- Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO)(Baseline, Month 6)
- Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients(Baseline, Month 6)
- Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex®(Baseline, Month 6)
- Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment(Baseline, Month 6)
- Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months(Baseline, Month 6)
- Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months(Baseline, Month 6)
- Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex®(Baseline, Month 6)
- Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments(Baseline, Month 6)
- Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye(Baseline, Month 24)
- Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye(Baseline, Week 6, Month 4, Month 12, Month 18, Month 24)