Observational Study to Evaluate and Compare the Rate and Extent of Inflammation After a Single Intravitreal Injection of Ranibizumab vs. a Single Intravitreal Injection of Aflibercept in Treatment Naive and Treatment Experienced Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- To evaluate post-intravitreal injection inflammatory response in patients receiving either ranibizumab or aflibercept.
研究概览
简要总结
This open-label, Phase IV prospective, observational study will evaluate patients, who have been diagnosed with Neovascular Age-Related Macular Degeneration and have previously received either a standard intravitreal injection of ranibizumab or aflibercept, in order to get and compare information regarding post-injection inflammatory (irritation in the eye)2-3 days post-injection.
Additionally, patients will be evaluated for visual acuity and pain 2-3 days post-injection.
详细描述
Patients, age 65 to 90, with Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept will be selected in this study. 300 subjects from one site in the United States will be enrolled.
Inclusion Criteria:
- Ability to provide written informed consent and comply with study
- Age 65-90 years
- Diagnosis of Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept
Exclusion Criteria:
- Previous intraocular inflammation
- Treatment with systemic anti-inflammatory agents
- Known systemic autoimmune diseases
- Treatment with intraocular steroids in the past 3 months
- History of intraocular surgery in the past 3 months
- Age greater than 90 years
- Patients who were switched between either therapies in the past 3 months
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age 65-90 years
- •Diagnosis or Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept
排除标准
- •Previous intraocular inflammation
- •Treatment with systemic anti-inflammatory agents
- •Known systemic autoimmune diseases
- •Treatment with intraocular steroids in the past 3 months
- •History of intraocular surgery in the past 3 months
- •Age greater than 90 years
- •Patients who were switched between either therapies in the past 3 months
结局指标
主要结局
To evaluate post-intravitreal injection inflammatory response in patients receiving either ranibizumab or aflibercept.
时间窗: 2-3 days after injection
All eyes will be evaluated 2-3 days after injection and graded in terms of (a) aqueous cells, graded subjectively on a scale of 0-4, (b) aqueous flare, graded subjectively on a scale 0-4, (c) aqueous flare graded objectively with the FM-600 Kowa flare meter and (d) vitreous haze, graded subjectively on a scale of 0-4.
次要结局
- To evaluate patients 2-3 days post-injection for best corrected visual acuity(2-3 days post-injection)