Retinal Ganglion Cell Function After Intravitreous Ranibizumab in Patients With Diabetic Macular Edema
2018年8月21日 更新者:Mauricio Maia、Federal University of São Paulo
Retinal Ganglion Cell Function After Repeated Intravitreous Ranibizumab in Diabetic Macular Edema
To evaluate the safety of intravitreal ranibizumab repeated injections in patients with diabetic macular edema regarding maintenance of retinal ganglion cell function.
研究概览
详细说明
- Ranibizumab can be a safe treatment for diabetic macular edema regarding maintenance of retinal ganglion cell function after repeated intravitreal injections.
- To evaluate the safety of intravitreal ranibizumab repeated injections in patients with diabetic macular edema regarding maintenance of retinal ganglion cell function.
- The primary endpoint for the study will be the changes in full-field and focal macular photopic negative response (PhRN) amplitude (in µV) over time, from baseline to month 12.
研究类型
介入性
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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SP
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São Paulo、SP、巴西、04023-062
- Dept of Ophthalmology - UNIFESP/Hospital São Paulo
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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:
- Male or female patients, older than 18 years, who have signed an informed consent.
- Patients with Type 1 or Type 2 diabetes mellitus and prior diagnosis of diabetic macular edema (DME), who had not undergone any previous treatment, either pharmacological or laser photocoagulation.
- Patients with visual impairment due to DME whom, in the opinion of the investigator, would benefit from treating with IVR.
Exclusion Criteria:
- Known hypersensitivity to ranibizumab or any of its components.
- Previous participation in any clinical studies of investigational drugs within 1 month
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
- Pregnant or nursing (lactating) women.
- Inability to comply with study or follow-up procedures.
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:Ranibizumab
monthly ranibizumab (0,5 mg injected intravitreally in a standard fashion) until maximum visual acuity (VA) is achieved and remains stable for three consecutive months (for a minimum of 3 initial injections).
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monthly ranibizumab (0,5 mg injected intravitreally in a standard fashion) until maximum visual acuity (VA) is achieved and remains stable for three consecutive months (for a minimum of 3 initial injections).
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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focal macular changes in full-field and photopic negative response (PhRN) amplitude (in µV)
大体时间:at Baseline and Months 3, 6, 9, 12
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The photopic negative response (PhNR) of the full-field cone electroretinograms (ERGs) is a functional indicator of retinal ganglion.
The PhNR consists of a negative-going wave that follows the photopic cone b wave.
The PhNR is selectively attenuated in patients with optic nerve disease and glaucoma, indicating that the PhNR can be an objective functional measure reflecting the sum of the total response of the retinal ganglion cells in the entire retina.
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at Baseline and Months 3, 6, 9, 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The mean change in BCVA
大体时间:monthly, from baseline to Month 12
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The mean change in best corrected visual acuity (BCVA) from baseline to month 12
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monthly, from baseline to Month 12
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the mean change in central macular thickness (CMT)
大体时间:monthly, from baseline to Month 12
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To assess the mean change in central macular thickness (CMT), measured in spectral-domain optical coherence tomography (SD-OCT) from baseline to month 12
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monthly, from baseline to Month 12
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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assess adverse events
大体时间:monthly, from Month 1 to Month 12
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To assess adverse events during the twelve months of the study.
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monthly, from Month 1 to Month 12
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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。
合作者
调查人员
- 首席研究员:Mauricio Maia, MD、UNIFESP / HOSPITAL SÃO PAULO
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
2014年3月1日
初级完成 (预期的)
2015年3月1日
研究完成 (预期的)
2015年7月1日
研究注册日期
首次提交
2014年2月3日
首先提交符合 QC 标准的
2014年2月3日
首次发布 (估计)
2014年2月5日
研究记录更新
最后更新发布 (实际的)
2018年8月22日
上次提交的符合 QC 标准的更新
2018年8月21日
最后验证
2014年2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.
Ranibizumab的临床试验
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Hoffmann-La Roche完全的
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Hoffmann-La Roche招聘中新生血管性年龄相关性黄斑变性比利时, 美国, 英国, 意大利, 阿根廷, 西班牙, 以色列, 澳大利亚, 奥地利, 巴西, 德国, 瑞士, 台湾, 法国
-
Hoffmann-La Roche招聘中新生血管性年龄相关性黄斑变性 (nAMD)比利时, 大韩民国, 德国, 西班牙, 英国, 澳大利亚, 意大利, 阿根廷, 以色列, 奥地利, 巴西, 法国, 新加坡, 瑞士, 台湾, 火鸡