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临床试验/NCT01926977
NCT01926977已完成1 期

Evaluation of Post Injection Inflammation and Pain After Ranibizumab vs Aflibercept Intravitreal Injections

Arshad Khanani1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Intravitreal injection of Ranibizumab 0.5mg once

干预措施: Ranibizumab 0.5mg (Drug)

Aflibercept 2.0mg Intravitreal injection

Active Comparator

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

发起方
Arshad Khanani
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Arshad Khanani

Vitreo-Retinal Surgeon

Sierra Eye Associates

研究点 (1)

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