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


Phase 0
N/A
N/A
Open (Enrolling)
Both
Glioblastoma, Optic Neuropathy

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Trial Information

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


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.


Inclusion Criteria:



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

Exclusion Criteria:

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Authority:

United States: Alleghney General Hospital

Study ID:

RC-5148

NCT ID:

NCT01331616

Start Date:

March 2011

Completion Date:

July 2012

Related Keywords:

  • Glioblastoma
  • Optic Neuropathy
  • Prospective study
  • Glioblastoma
  • Avastin
  • Visual Evoked Potential
  • Optic neuropathy
  • Chemo-radiotherapy
  • Glioblastoma
  • Optic Nerve Diseases
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Neurotoxicity Syndromes

Name

Location
Allegheny General Neurology Department/Neuro-Oncology Pittsburgh, Pennsylvania  15212