Safety and Efficacy of Dexamethasone (OZURDEX®) Intravitreal Implant in Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 724
- 主要终点
- Number of Patients With Adverse Events or Adverse Drug Reactions
研究概览
简要总结
This study is a Post-Market Surveillance study in Korea to evaluate the safety and efficacy of dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant used to treat Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye in clinical practice.
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
- •Patients with Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye treated with (OZURDEX®) in clinical practice.
排除标准
- •Patients with eye infections
- •Patients with glaucoma.
研究组 & 干预措施
OZURDEX®
Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
干预措施: dexamethasone 700 ㎍ intravitreal implant (Drug)
结局指标
主要结局
Number of Patients With Adverse Events or Adverse Drug Reactions
时间窗: 4 Years
An Adverse Event is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction is a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.
次要结局
- Percentage of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye(4 Years)