Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO Exacerbations
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.
Neuromyelitis Optica Spectrum Disorder
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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).|
- Change in Expanded Disability Status Score (EDSS) [ Time Frame: 91 days ] [ Designated as safety issue: No ]
The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability.
- Safety Assessment [ Time Frame: 91 days ] [ Designated as safety issue: Yes ]
- Frequency and severity of adverse events.
- Frequency of serious adverse events.
- Percentage of subjects withdrawing due to adverse events.
- Change from baseline in hematology, chemistry, and urinalysis parameters.
|Study Start Date:||June 2013|
|Study Completion Date:||May 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase.
Other Name: Avastin
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777412
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Michael Levy, MD, PhD||Johns Hopkins University|