drugset / Trial / NCT01777412
Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO Exacerbations
Phase 1
Completed
10 enrolled
Johns Hopkins University
Genentech, Inc. · collabGuthy Jackson Charitable Foundation · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2013-06
- Primary completion
- 2015-02
- Completion
- 2015-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 10 mg/kg | Intravenous |