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临床试验/NCT02332941
NCT02332941已完成1 期

Intravitreal Rituximab

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2014年8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
入组人数
5
试验地点
1
主要终点
Central Macular Thickness

研究概览

简要总结

The purpose of this study is to determine if treatment of Age Related Macular Degeneration (AMD) with a new medication,rituximab is effective. To address this issue, investigators propose a clinical trial in which patients with late stage disease, poor vision and who have failed treatment by conventional means will receive rituximab by direct injection into the affected eye and will be followed for improvement in the structure of their retina. Age Related Macular Degeneration (AMD) is a leading cause of vision loss in the elderly with routine care involving injections in the eye to improve and to prevent worsening of vision. However, some patients do not respond to the medications that we currently have and as such an alternative medication is needed. One potential medication is rituximab, which has been injected into the eye for primary eye cancer, and has been tolerated well and led to patient improvement. Investigators will obtain baseline eye tests then plan on injecting this medication in to the eye of our patients with late stage AMD, by first placing numbing drops into the eye, then injecting the medication directly into the eye using sterile techniques. Investigators will then follow the patient and repeat eye tests to monitor for improvements.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
41 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over the age of 40
  • Patients who have a diagnosis of wet age-related macular degeneration
  • Patients who have a central visual acuity ,20/200
  • Patients who have been deemed "treatment-resistant" at the discreation of the treating physician

排除标准

  • Patients with treatment failure for neovascular AMD
  • Patients who have tried multiple anti-vegf medication without anatomical or objective improvement

研究组 & 干预措施

Single Arm

Experimental

This is a pilot study. It will be an interventional, prospective, observational, clinical study that seeks to evaluate the effect of intravitreal rituximab over a period of one month.

干预措施: Rituximab (Drug)

结局指标

主要结局

Central Macular Thickness

时间窗: 2 years

Primary measure will be Central Macular Thickness as recorded with Optical Coherence Tomography.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rithwick Rajagopal

Assistant Professor

Washington University School of Medicine

研究点 (1)

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