A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion (COBALT)
2019年4月9日 更新者：Allergan
This study will evaluate the safety and efficacy of OZURDEX® (700 µg dexamethasone implant) in patients with macular edema associated with branch retinal vein occlusion.
研究概览
研究类型
介入性
注册 (实际的)
71
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Seoul、大韩民国
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diagnosis of macular edema
- Best corrected visual acuity of approximately 20/400 to 20/40 in the study eye
Exclusion Criteria:
- Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month
- Intraocular surgery, including cataract surgery, and/or laser surgery of any type within 3 months
- Any active ocular infection in either eye
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：OZURDEX®
OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
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OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6
大体时间：Baseline, Month 6
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BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best).
A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.
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Baseline, Month 6
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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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Change From Baseline in Central Retinal Thickness (CRT) at Month 6
大体时间：Baseline, Month 6
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CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina.
A negative change from Baseline indicates an improvement.
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Baseline, Month 6
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Change From Baseline in BCVA at Month 12
大体时间：Baseline, Month 12
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BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best).
A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.
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Baseline, Month 12
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Change From Baseline in CRT at Month 12
大体时间：Baseline, Month 12
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CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina.
A negative change from Baseline indicates an improvement.
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Baseline, Month 12
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Change From Baseline in BCVA at Each Visit
大体时间：Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
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BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best).
A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.
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Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
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Change From Baseline in CRT at Each Visit
大体时间：Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
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CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina.
A negative change from Baseline indicates an improvement.
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Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
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Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA
大体时间：Baseline, Months 6 and 12
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BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best).
An increase in the number of letters read correctly means that the vision improved and a decrease in the number of letters read correctly means that the vision has worsened.
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Baseline, Months 6 and 12
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Percentage of Participants Receiving a Second Injection
大体时间：12 Months
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12 Months
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Percentage of Participants Receiving a Third Injection
大体时间：12 Months
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12 Months
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Time to Second Injection
大体时间：12 Months
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Time in weeks from the first injection to the second injection.
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12 Months
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Time to Third Injection
大体时间：12 Months
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Time in weeks from the second injection to the third injection.
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12 Months
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Percentage of Participants Who Received Laser Treatments
大体时间：12 Months
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Participants underwent laser photocoagulation therapy for all areas of foveal leakage and non-perfusion, as well as areas of extensive retinal hyperplasia if applicable for rescue therapy.
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12 Months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年7月16日
初级完成 (实际的)
2014年9月24日
研究完成 (实际的)
2015年3月30日
研究注册日期
首次提交
2013年7月16日
首先提交符合 QC 标准的
2013年7月18日
首次发布 (估计)
2013年7月19日
研究记录更新
最后更新发布 (实际的)
2019年4月17日
上次提交的符合 QC 标准的更新
2019年4月9日
最后验证
2019年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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