NCT01331616

Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: West Penn Allegheny Health System · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Glioblastoma
• Optic Neuropathy

Interventions

Type	Name	Description
DRUG	Bevacizumab (Avastin)	Dosage is: 10 mg/kg every 2 weeks as monotherapy or in combination (unlabeled) with irinotecan. Patients will also receive Radiotherapy prior to beginning chemotherapy.

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-04-08
• Last updated: 2021-12-09