Study to Evaluate Efficacy of Aflibercept in Neovascular Age-related Macular Degeneration Patients Non Responders to Anti-Vascular Endothelial Growth Factor (MACBETH)
2018年11月21日 更新者：Barcelona Macula Foundation
Phase IV Study to Evaluate the Efficacy of Aflibercept in Subjects With Neovascular Age-related Macular Degeneration (wAMD), Without Optimal Response to Repeated Monthly Intravitreal Injections of Anti Vascular Endothelial Growth Factor (Anti VEGF-A) Therapy.
Patients with neovascular age-related macular degeneration who do not respond to usual treatment with conventional medications may respond to a new drug of the same class which is designed to block a larger fraction of proangiogenic factors.
研究概览
研究类型
介入性
注册 (实际的)
46
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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Barcelona、西班牙、08022
- Barcelona Macula Foundation
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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
50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:
- Signed Informed Consent
- Men and women ≥ 50 years of age.
- Any choroidal neovascular membranes (CNVM) lesion (occult, minimally classic or classic) secondary to age-related macular degeneration
- Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of: 20/32 to 20/320 (letter score of 73 to 25) in the study eye.
- Able to return for ALL clinic visits and complete all study-related procedures.
- Absence of other ocular diseases that could affect visual acuity.
Patients without optimal response to ranibizumab or bevacizumab defined as:
- Patient with significant persistent or recurrent fluid (intraretinal or subretinal) on OCT or any leakage on fluorescein angiography despite at least 4 injections within last 6 months, being the last OCT with presence of fluid within the 6 weeks after last treatment with ranibizumab or bevacizumab.
- Patient with significant persistent or recurrent fluid (intraretinal or subretinal) on OCT or any leakage on fluorescein angiography despite three monthly treatment with ranibizumab or bevacizumab.
Exclusion Criteria:
- No scar, fibrosis, or atrophy involving the center of the fovea
- No retina pigment epithelium (RPE) rip/tear involving the central fovea
- Participation in another simultaneous interventional clinical trial
- Prior treatment with anti-VEGF or steroids therapy in the study eye within 28 days of baseline
- Prior treatment with photodynamic therapy (PDT)
- Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
- Active intraocular inflammation in the study eye
- History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
- Unable to undergo fluorescein angiography or fundus photography because of uncontrolled allergies
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：0.5mg AFLIBERCEPT injection
Patients will receive intravitreal injection of aflibercept 0.5mg at baseline, week 4,8,16,24 and 32.
Optionally, if intra or subretinal fluid persists at week 12, patients will receive an additional injection.
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0.5mg aflibercept intravitreal injection will be performed every 4 weeks from baseline to week 8 (3 doses) and every 8 weeks until week 32.
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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Percentage of patients with no fluid on Optical Coherence Tomography (OCT) after loading dose of aflibercept
大体时间：Week 12
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At week 12 an OCT will be performed to evaluate the changes in intra or subretinal fluid and to determine the percentage of patients with no fluid after 3 doses of aflibercept injected on baseline visit, week 4 and week 8.
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Week 12
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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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Changes in best corrected visual acuity (BCVA)after loading dose
大体时间：week 12
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week 12
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Changes in OCT central foveal thickness after loading dose
大体时间：week 12
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week 12
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Anatomic and Visual Acuity outcomes maintained during (every 8 weeks) treatment.
大体时间：week 40
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week 40
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Determine the time to resolution of any intra/sub retinal fluid on OCT
大体时间：week 4,8,12,24,32,40
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week 4,8,12,24,32,40
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Describe safety of this cohort of patients
大体时间：baseline, week 4, 8, 12, 24, 32 and 40
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Describe the safety of aflibercept in study patients by determining ocular and non ocular adverse events classified according to type, frequency and severity during 40 weeks
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baseline, week 4, 8, 12, 24, 32 and 40
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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。
调查人员
- 首席研究员：Jordi Mones, MD PhD、Barcelona Macula Foundation
- 首席研究员：Carlos Juan Donate, MD、Hospital San Carlos, Madrid
- 首席研究员：Marta Suárez de Figueroa, MD、Hosipital Universitario Ramon y Cajal
- 首席研究员：Jose Luis Olea, MD、Hospital Son Espases
- 首席研究员：Francisco Cabrera, MD、Hospital Universitario Insular de Canarias
- 首席研究员：Laura Sarasols, MD、Hospital Universitari General de Catalunya
- 首席研究员：Javier Araiz, MD、Instituto Clínico Quirúrgico de Oftalmología de Bilbao
- 首席研究员：Jose Maria Ruiz-Moreno, MD、Hospital Universitario de Albacete
- 首席研究员：Ignasi Jürgens, MD PhD、Institut Catalâ de Retina
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1日
初级完成 (实际的)
2014年11月1日
研究完成 (实际的)
2015年6月1日
研究注册日期
首次提交
2013年7月8日
首先提交符合 QC 标准的
2013年7月10日
首次发布 (估计)
2013年7月11日
研究记录更新
最后更新发布 (实际的)
2018年11月23日
上次提交的符合 QC 标准的更新
2018年11月21日
最后验证
2015年7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.