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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT01777412
Phase
PHASE1
Status
Completed

Conditions

  • Neuromyelitis Optica
  • Neuromyelitis Optica Spectrum Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Jan 28, 2013
Start date
Jun 30, 2013
Status verified
Aug 2015
Primary completion
Feb 28, 2015
Completion
May 31, 2015

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab
    Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase.

Primary Outcome Measure

Baseline Expanded Disability Status Score (EDSS) [ Time Frame: Admission to hospital ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287-

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By research site
Johns Hopkins Hospital· Baltimore, MD

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