Retrospective Study of the Safety and Efficacy of Suprachoroidal CLS-TA in Combination With Intravitreal Aflibercept for the Treatment of Macular Edema Associated With RVO in Subjects Who Completed Parent Study CLS1003-201
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Time to additional therapy for RVO
研究概览
简要总结
The purpose of this non interventional retrospective study is to continue to collect data from patients following their completion of Protocol CLS 1003-201: "Safety and Efficacy of Suprachoroidal CLS-TA with Intravitreal Aflibercept in Subjects with Macular Edema Following Retinal Vein Occlusion" (ie, the parent study).
详细描述
This is a non-interventional, retrospective study of up to 6 months for subjects that completed the parent study CLS1003-201. This study is designed to collect data from patients following their parent study exit visit, through either the time of the next treatment for RVO or at least 6 months following the parent study exit visit, whichever occurs first.
During this non-interventional retrospective study, the following data will be collected in an online questionnaire (or where required, on paper) provided by Clearside:
- Next RVO therapy administered (if applicable), including reason for treatment
- Continued documentation of current or changes in medical or ocular conditions following parent study
- Concomitant drug or therapy changes
- Visual acuity, including details on the method used in the assessment
- Central retinal thickness, including details on the equipment used in its determination
- Intraocular pressure, including details on the equipment used in its determination
Subjects will be selected based on parent study primary investigator's access to their medical records access, following exit from CLS1003-201. Data will also be collected on the total number of patients included in this non interventional study as well as reasons patients were excluded. Data will be summarized from the randomization treatment assignment in the parent study.
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
- •Completed enrollment and did not receive additional aflibercept therapy in the Parent study, CLS1003-201
排除标准
- 未提供
结局指标
主要结局
Time to additional therapy for RVO
时间窗: 6 months following exit from Parent study
次要结局
- Mean change from baseline in central subfield thickness(6 months following exit from Parent study)
- Mean change from baseline for intraocular pressure(6 months following exit from Parent study)
- Mean change from baseline in best corrected visual acuity(6 months following exit from Parent study)