NCT01777412

Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO Exacerbations

An Open-label Phase 1b Study of Avastin® (Bevacizumab) for the Treatment of Acute Optic Neuritis and/or Transverse Myelitis in Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1b interventional trial of bevacizumab (Avastin®) to evaluate the tolerability/safety and preliminary efficacy of bevacizumab (Avastin®) as add-on therapy for treatment of acute optic neuritis and/or transverse myelitis in neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD). A single infusion of Avastin® is added to standard-of-care high dose steroids and an additional dose of Avastin® is added to plasma exchange (if necessary). The primary outcomes are clinical changes in the Expanded Disability Severity Scale, Timed 25-foot Walk and Low Contrast Visual Acuity, MRI parameters and safety.

Detailed description

Study Objective: The overall objective is to evaluate the tolerability/safety and efficacy of adding bevacizumab (Avastin®) to standard of care therapy in improving clinical and radiologic outcomes of acute optic neuritis and/or transverse myelitis in neuromyelitis optica and neuromyelitis optica spectrum disorders. Primary Objective: To compare the clinical and radiographic outcome following acute optic neuritis and/or transverse myelitis in NMO/NMOSD in patients who receive 1-2 doses of 10 mg/kg dose of bevacizumab (Avastin®) in addition to standard medical therapy. Secondary Objectives: * To determine the effect of Avastin on NMO clinical scores (Expanded Disability Status Scale, Timed 25-foot Walk and Low Contrast Visual Acuity \[LCVA\]). * To evaluate the safety and tolerability of a 10 mg/kg dose of intravenous Avastin. * To determine the frequency of adverse events with Avastin in this patient population. * To determine the effect of Avastin on MRI lesion size and extent. The duration of the investigation is 1-2 years.

Conditions

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Bevacizumab

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-02-01
• Completion: 2015-05-01
• First posted: 2013-01-28
• Last updated: 2015-08-21
• Results posted: 2015-05-29

Locations

1 site across 1 country: United States