NCT01896284已完成4 期
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.
Barcelona Macula Foundation1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Percentage of patients with no fluid on Optical Coherence Tomography (OCT) after loading dose of aflibercept
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
0.5mg AFLIBERCEPT injection
Experimental
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.
干预措施: 0.5mg aflibercept (Drug)
结局指标
主要结局
Percentage of patients with no fluid on Optical Coherence Tomography (OCT) after loading dose of aflibercept
时间窗: Week 12
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.
次要结局
- Changes in best corrected visual acuity (BCVA)after loading dose(week 12)
- Anatomic and Visual Acuity outcomes maintained during (every 8 weeks) treatment.(week 40)
- Changes in OCT central foveal thickness after loading dose(week 12)
- Determine the time to resolution of any intra/sub retinal fluid on OCT(week 4,8,12,24,32,40)
- Describe safety of this cohort of patients(baseline, week 4, 8, 12, 24, 32 and 40)
研究者
研究点 (1)
Loading locations...
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