Evaluation of Post Injection Inflammation and Pain After Ranibizumab vs Aflibercept Intravitreal Injections
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evidence of Anterior Chamber Inflammation
研究概览
简要总结
This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of Ranibizumab vs Aflibercept.
详细描述
This is an open-label, Phase I-II study of post injection pain and inflammation after intravitreally administered Ranibizumab and Aflibercept in 100 subjects with Neovascular Age-Related Macular Degeneration. We will enroll both treatment experienced ( patients who were treated with Lucentis or Eylea, but not Avastin in the past) and treatment naive patients ( new onset Neovascular AMD with no history of intravitreal injections).
The treatment experienced patients will be treated with the intravitreal medication other than what they were receiving in the past, for example, patients treated with Lucentis will switch to Eylea for study purposes and vice versa.
Consented, enrolled subjects will receive open-label intravitreal injection of either 0.5mg Ranibizumab or 2mg Aflibercept. A standard intravitreal injection protocol will be followed. Patients will be reevaluated between 24-48 hours and 5-7 days post injections. A non-injecting physician will evaluate the patients for anterior chamber inflammation; this physician will be blinded about the specific treatment. Anterior chamber inflammation is described as any cell or flare in the anterior chamber. These will be evaluated using Standardization of Uveitis Nomenclature (SUN) working group classifications.
Pain score will be evaluated using a Numerical Rating Scale. Each patient will have a standard script verbally read to them at their visit, and asked to rate their pain based on this scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide informed consent and comply with study assessments for the full duration of the study
- •Age >/= 65 years
- •New onset Neovascular Age-Related Macular Degeneration or (See No.4)
- •Previously treated Neovascular Age-Related Macular Degeneration with Lucentis or Eylea intravitreal injections
- •Visual Acuity of 20/400 or better
- •No history of Post injection pain or inflammation with prior treatments -
排除标准
- •History of Endophthalmitis in either eye
- •Uncontrolled or symptomatic Dry Eye Syndrome
- •History of Anterior or Posterior Uveitis
- •History of Post injection pain or inflammation with prior treatments
- •Recent thromboembolic event(<3 months)
- •Pregnancy(positive pregnancy test) or Lactation/Premenopausal women not using adequate contraception -
研究组 & 干预措施
Ranibizumab 0.5mg Intravitreal injection
Intravitreal injection of Ranibizumab 0.5mg once
干预措施: Ranibizumab 0.5mg (Drug)
Aflibercept 2.0mg Intravitreal injection
Intravitreal Aflibercept 2.0mg once
干预措施: Aflibercept 2.0mg (Drug)
结局指标
主要结局
Evidence of Anterior Chamber Inflammation
时间窗: 24 to 48 hours (visit #1) and 5 to 7 days (visit #2)
Evidence of anterior chamber inflammation at visit #1 and #2 using Standardization of Uveitis Nomenclature (SUN)
次要结局
- Patients With Post Injection Pain Score of One or Higher on Pain Scale(24 to 48 hours (visit #1) and 5 to 7 days (visit #2))
研究者
Arshad Khanani
Vitreo-Retinal Surgeon
Sierra Eye Associates
