A Randomized, Double-blind, Multicenter, Sham-controlled, Safety and Efficacy Study of Conbercept in Patients With mCNV (SHINY)
2014年6月3日 更新者：Chengdu Kanghong Biotech Co., Ltd.
The Safety and Efficacy of Conbercept in the Treatment of Choroidal Neovascularization (CNV) Secondary to High Myopia
This study is design to evaluate the effect of conbercept therapy on visual acuity and anatomic outcomes compared to sham injection and durability of response observed in subjects with choroid neovascularization secondary to pathological myopia.
研究概览
地位
未知
研究类型
介入性
注册 (预期的)
176
阶段
- 第三阶段
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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Beijing
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Beijing、Beijing、中国、100083
- Peking University Third Hospital
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Beijing、Beijing、中国、100032
- Peking Union Medical College Hospital
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Beijing、Beijing、中国、100730
- Beijing Tongren Hospital affiliated to Capital Medical University
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Chongqing
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Chongqing、Chongqing、中国、400038
- Southwest Hospital
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Chongqing、Chongqing、中国、400042
- Daping Hospital, Research Institute of Surgery Third Military Medical University
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Guangdong
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Guangzhou、Guangdong、中国、510060
- Zhongshan Ophthalmic Center
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Hubei
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Wuhan、Hubei、中国、430070
- Wuhan General Hospital of Guangzhou Military
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Jiangsu
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Wuxi、Jiangsu、中国、214002
- Wuxi No.2 People's Hospital
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Shandong
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Qingdao、Shandong、中国、266071
- Ophthalmologic Hospital of Qingdao
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Shanghai
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Shanghai、Shanghai、中国、200080
- Shanghai First People's Hospital
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Shanxi
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Xian、Shanxi、中国、710032
- Xijing Hospital
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Sichuan
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Chengdu、Sichuan、中国、610041
- West China Hospital of Sichuan University
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Zhejiang
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Wenzhou、Zhejiang、中国、325027
- The Affiliated Eye Hospital of WMC
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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:
- Patients give fully informed consent and are willing and able to comply with all study procedures.
In the study eye:
- Myopia of equal to or greater than -6.00D,and axial length ≥26.5mm.
- Diagnosis of active subfoveal, juxafoveal, or extrafoveal CNV secondary to high myopia.
- Visual impairment due to CNV secondary to high myopia.
- BCVA score ≥24 and ≤73 ETDRS letters (approximately 20/40~ 20/320 Snellen equivalent).
- Ocular media of sufficient quality to obtain fundus and OCT images.
- The BCVA score of fellow eyes ≥ 19 ETDRS letters (approximately 20/400 Snellen equivalent)
Exclusion Criteria:
- Current vitreous hemorrhage in either eye.
- Intraocular treatment with corticosteroids within last 3 months or periocular treatment with corticosteroids within last month in the study eye.
- Active infectious ocular inflammation in either eye.
- Fibrosis or atrophy involving the center of foveal in the study eye.
- Any concurrent intraocular condition in the study eye that, in the opinion of investigator, could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition.
- The lesion size ≥30 mm2 in the study eye.
- Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results.
- Uncontrolled glaucoma or cup/disk ratio > 0.8 in the study eye.
- Aphakia (excluding artificial lens) in the study eye.
- Serious amblyopia and amaurosis in the fellow 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：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：conbercept treatment group
Subjects will receive conbercept injections at a dose of 0.5 mg/eye, once a month for first 3 months.
In the next 6 months, the investigator will decide whether repeat injections are needed base on the monthly assessment results.
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intravitreal injection of 0.5 mg conbercept per month, fixed injection
intravitreal injection of 0.5 mg conbercept as need, PRN
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假比较器：sham injection group
Subjects will receive sham injections monthly for 3 months and will receive 0.5 mg/eye conbercept at month 4. The investigator will decide whether repeat injections are needed base on the monthly assessment results from month 5 to month 9.
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intravitreal injection of 0.5 mg conbercept per month, fixed injection
intravitreal injection of 0.5 mg conbercept as need, PRN
sham intravitreal injection per month, fixed injection
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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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mean change from baseline of visual acuity
大体时间：3-month
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to compare the mean change from baseline of best-corrected visual acuity (BCVA) between conbercept treatment group and sham injection group at month 3
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3-month
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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 of anatomical features
大体时间：3-month
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to compare the difference of mean change from baseline of CRT, CNV size and lesion size between conbercept treatment group and sham injection group at month 3
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3-month
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mean change from baseline of visual acuity
大体时间：9 months
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to evaluate the mean change from baseline of BCVA of two groups from month 1 to month 9
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9 months
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safety and tolerability of conbercept
大体时间：3-month and 9-month
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to evaluate the incidence of AEs (ocular or non-ocular) of two groups at month 3 and 9
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3-month and 9-month
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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。
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
2012年8月1日
初级完成 (实际的)
2014年2月1日
研究完成 (预期的)
2015年3月1日
研究注册日期
首次提交
2013年3月11日
首先提交符合 QC 标准的
2013年3月11日
首次发布 (估计)
2013年3月12日
研究记录更新
最后更新发布 (估计)
2014年6月4日
上次提交的符合 QC 标准的更新
2014年6月3日
最后验证
2014年3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.