NCT01445626已完成不适用
A Retrospective Data Collection Study in Patients Receiving Dexamethasone Intravitreal Implant (Ozurdex®) for Macular Oedema Due to Retinal Vein Occlusion (RVO)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 87
- 主要终点
- Time to OZURDEX® Re-injection
研究概览
简要总结
This study will use retrospective data to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular oedema due to Retinal Vein Occlusion (RVO).
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 oedema in the study eye due to BRVO or CRVO
- •Received at least 2 OZURDEX® injections in the study eye
排除标准
- •Received OZURDEX® injections as part of or during any clinical study
研究组 & 干预措施
All participants
Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
干预措施: dexamethasone intravitreal implant 0.7 mg (Drug)
结局指标
主要结局
Time to OZURDEX® Re-injection
时间窗: Up to 12 months
Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections.
次要结局
- Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection(Baseline, 7 to 12 weeks following the last injection)
- Percentage of Patients With an Increase of 2 Lines or More in BCVA(Baseline, Up to 12 months)
- Percentage of Patients With an Increase of 3 Lines or More in BCVA(Baseline, Up to 12 months)
- Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection(Baseline, 7 to 12 weeks following the last injection)
- Time to Improvement of 2 Lines or More in BCVA(Baseline, Up to 12 months)
- Time to Improvement of 3 Lines or More in BCVA(Baseline, Up to 12 months)
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