Peripheral and Macular Retinal Vascular Perfusion and Leakage Dynamics in Diabetic Macular Edema and Retinal Venous Occlusions During Intravitreal Aflibercept Injection (IAI) Treatment for Retinal Edema: PERMEATE Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in Panretinal Leakage Index at Month 12 From Baseline
研究概览
简要总结
This interventional study will evaluate the retinal vascular dynamics associated with Intravitreal Aflibercept Injection (IAI) therapy in eyes with diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO). Ultra-widefield fluorescein angiography and optical coherence tomography (OCT) angiography will be performed at multiple timepoints to assess the changes in retinal vascular leakage, ischemia, and vascular abnormalities throughout the study duration and compare these alterations to baseline.
详细描述
Diabetic macular edema (DME) and macular edema secondary to retinal venous occlusive diseases are the most common cause of vision loss from a retinal vascular disease. Recently, vascular endothelial growth factor (VEGF) inhibitors (bevacizumab, aflibercept, and ranibizumab) have been described as new first-line therapies for these conditions. Aflibercept is the most recently approved VEGF inhibitor for the management of these conditions. Clinical trials have shown that treatment with aflibercept improves visual acuity and reduces macular edema in a large percentage of patients.
This study will examine the changes that occur with intravitreal aflibercept to perfusion and leakage in treatment naive eyes over the course of 1 year.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Aflibercept
Monthly aflibercept for 6 months and then every other month for 6 months.
干预措施: Aflibercept (Drug)
结局指标
主要结局
Change in Panretinal Leakage Index at Month 12 From Baseline
时间窗: 12 months
Change in panretinal leakage index (defined as the proportion of retinal area involved in angiographic leakage) at month 12 from baseline as measured by ultra-widefield angiography (UWFA).
次要结局
- Mean Change in Total Leakage Index(6 months)
- Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) Score Based on ETDRS(12 months)
- Change in Panretinal Ischemic Index(12 months)
- Number of Patients That Showed Visual Acuity 20/40 or Better(12 months)
- Number of Patients That Showed Visual Acuity 20/200 or Worse(12 months)
- Number of Patients Who Gained 15 ETDRS Letters or More of Vision(6 months)
- Ocular Serious Adverse Events(12 months)
- Change in Panretinal Ischemic Index From Baseline at 6 Months(6 months)
- Mean Change From Baseline Central Subfield Thickness(12 months)
- Number of Participants Who Gained 15 ETDRS Letters or More of Vision(12 months)
- Number of Participants Who Lost 15 ETDRS Letters or More of Vision(6 months)
- Systemic Serious Adverse Events(12 Months)
研究者
Justis Ehlers
Assistant Professor of Ophthalmology
The Cleveland Clinic