Neuromyelitis Optica Clinical Trial
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).
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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