A Single Arm, Investigator Initiated Study of the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Injection in Subjects With Exudative Age-related Macular Degeneration Previously Treated With Ranibizumab or Bevacizumab (ASSESS Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in Central Subfield Thickness From Baseline at 12 Months
研究概览
简要总结
This study will examine the use of Aflibercept in patients with exudative macular degeneration requiring intravitreal injections. Patients will be followed for 24 months. The follow up phase will be completed at month 36.
详细描述
The purpose of this study is to examine the use of Aflibercept in patients who have been previously treated with Ranibizumab or Bevacizumab for exudative macular degeneration. Specifically, we will examine its effect on macular degeneration, measured by SDOCT (Spectral Domain Optical Coherence Tomography) and ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity. This will be a prospective study with patients to receive an intravitreal injection of Aflibercept at the time of treatment.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment with Aflibercept
Subjects were given 2 mg (0.05 mL) of intravitreal aflibercept injection administered every month for the first 3 months, followed by 2 mg (0.05 mL) once every 2 months as per the drug label for the next 9 months.
干预措施: Aflibercept (Drug)
结局指标
主要结局
Change in Central Subfield Thickness From Baseline at 12 Months
时间窗: baseline and 12 months
The mean absolute change from baseline central subfield thickness at 12 months as measured by SDOCT
次要结局
- Change in Best-corrected Visual Acuity From Baseline at 12 Months(Baseline and 12 months)
- Change in Cube Average Thickness From Baseline at 12 Months(baseline and 12 months)
- Change in Macular Volume From Baseline at 12 Months.(baseline and 12 months)
- Percentage of Patients Who Gained Greater Than 15 Letters of Vision From Baseline at 12 Months.(baseline and 12 months)
- Percentage of Patients Who Lost Greater Than 15 Letters of Vision From Baseline at 12 Months(baseline and 12 months)
- Percentage of Subjects Who Were 20/40 or Better at Month 12.(month 12)
- Percentage of Subjects Who Were 20/200 or Worse at Month 12.(month 12)
研究者
Rishi Singh
MD
The Cleveland Clinic