跳至主要内容
临床试验/NCT01331616
NCT01331616撤回早期 1 期

A Prospective Single Institution Study of Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab

West Penn Allegheny Health System0 个研究点开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
撤回
主要终点
Measurement of Visual Evoked Potentials (optic nerve function and visual processing) and optic nerve function in 10 patients.

研究概览

简要总结

Does treatment with bevacizumab (Avastin) in combination with prior or current radiotherapy lead to optic neuropathy?

详细描述

The investigators research will focus on patients prior to them beginning treatment with bevacizumab (Avastin), by undergoing a baseline visual examination with Visual evoked Potentials testing. This will allow testing of the patient's optic nerve function bilaterally. Patients will then begin their normally scheduled treatment with avastin, and other chemotherapeutic agents, as well any radiation treatments scheduled. Once patients have completed their treatment with avastin for 6-8 weeks, they will then undergo their second Visual Evoked Potential testing, with both studies then being compared for any changes within the optic nerves. Patients will also be recommended to have stringent follow up with an Ophthalmologist to include confrontational visual field testing, external and anterior segment examination, and dilated fundus examination. The investigators main objective is to assess whether or not bevacizumab causes a direct toxic effect on patient's optic nerves leading to an acute/subacute optic neuropathy.

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

性别
All
接受健康志愿者

入选标准

  • Diagnosed w Glioblastoma grade IV, and scheduled to begin chemo radiotherapy with Avastin

排除标准

  • No diagnosis of GBM, not scheduled to begin treatment with avastin in combination with radiotherapy.

研究组 & 干预措施

Bevacizumab (Avastin)

Experimental

干预措施: Bevacizumab (Avastin) (Drug)

结局指标

主要结局

Measurement of Visual Evoked Potentials (optic nerve function and visual processing) and optic nerve function in 10 patients.

时间窗: 1 year

Does Avastin lead to optic neuropathy in combination w chemo-radiotherapy? Our research will focus on patients prior to them beginning treatment with bevacizumab (Avastin), by undergoing Visual evoked Potentials testing. This will allow testing of the patient's optic nerve function bilaterally. In our study of VEP, we will be measuring optic nerve function, to asses if there has been any damage.

次要结局

  • Number of patients diagnosed with optic neuropathy following treatment with chemo and radiation in combination with avastin treatment(1 year)

研究者

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

Dawnmarie DeFazio

Physician

West Penn Allegheny Health System

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