Retrospective Study of the Safety and Efficacy of Patients With RVO in Subjects Who Completed Parent Study CLS1003-201
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
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Texas
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San Antonio、Texas、美国
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Completed enrollment and did not receive additional aflibercept therapy in the Parent study, CLS1003-201
Exclusion Criteria:
- N/A
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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CLS1003-201
Those subjects whose parent study primary investigator has access to their medical records, following exit from CLS1003-201.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Time to additional therapy for RVO
大体时间:6 months following exit from Parent study
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6 months following exit from Parent study
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Mean change from baseline for intraocular pressure
大体时间:6 months following exit from Parent study
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Measured by applanation tonometry
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6 months following exit from Parent study
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Mean change from baseline in central subfield thickness
大体时间:6 months following exit from Parent study
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Based on spectral domain optical coherence tomography
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6 months following exit from Parent study
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Mean change from baseline in best corrected visual acuity
大体时间:6 months following exit from Parent study
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Based on ETDRS
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6 months following exit from Parent study
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合作者和调查者
调查人员
- 研究主任:Thomas Ciulla, MD、Clearside Biomedical, Inc.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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