NCT01566526已完成不适用
Retrospective Data Collection Study in Patients Receiving Two or More OZURDEX® Injections for Macular Oedema Secondary to Retinal Vein Occlusion
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
- 26
- 主要终点
- Time to OZURDEX® Re-Injection in the Study Eye
研究概览
简要总结
The purpose of this study is to 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) in patients who received OZURDEX® as part of the Belgium Medical Needs Program.
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 at least one eye due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
- •Received at least two OZURDEX® injections in the study eye as part of the Belgium Medical Needs Program
排除标准
- 未提供
研究组 & 干预措施
Patients Previously Treated with OZURDEX®
OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
干预措施: dexamethasone intravitreal implant 0.7 mg (Drug)
结局指标
主要结局
Time to OZURDEX® Re-Injection in the Study Eye
时间窗: Up to 12 Months
The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye.
次要结局
- Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye(Baseline, 7 to 12 weeks following the last injection)
- Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye(Baseline, Up to 12 Months)
- Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye(Baseline, Up to 12 Months)
- Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection(Baseline, 7 to 12 weeks following the last injection)
- Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye(Baseline, Up to 12 Months)
- Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye(Baseline, Up to 12 Months)
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