Drug Utilization Study in Patients Receiving Ozurdex™ (Dexamethasone Intravitreal Implant) 0.7 mg Injections for Visual Impairment Due to Diabetic Macular Edema (DME)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Time to OZURDEX® Reinjection
研究概览
简要总结
A retrospective, non-interventional, observational, multi-center, drug utilization study to be conducted in adult participants with visual impairment due to DME treated with Ozurdex implants in Germany and Switzerland from 1 January 2015 to 1 September 2017.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Participant received at least two Ozurdex® implants in the study eye to treat visual impairment due to DME
- •First Ozurdex® implant injection occurred after 1 January 2015
- •Participant was followed-up at the site for at least 12 months after the first Ozurdex® implant in the study eye
排除标准
- •Participant received Ozurdex® implants as part or during a clinical study
研究组 & 干预措施
OZURDEX®
Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice.
干预措施: Dexamethasone intravitreal implant (Drug)
结局指标
主要结局
Time to OZURDEX® Reinjection
时间窗: Up to 44 months
The time to reinjection is defined as the time in months from the date of one OZURDEX® injection to the subsequent OZURDEX® injection.
Mean Number of OZURDEX® Implant Reinjections in the Study Eye
时间窗: Up to 44 months
Study eye was defined as the eye that received the most OZURDEX® injections.
次要结局
- Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection(Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection)
- Percentage of Participants Who Experienced At Least One Adverse Events of Special Interest (AESIs)(Up to 44 months)
- Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection(Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection)
- Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection(Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection)
- Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection(Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection)