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Bevacizumab for Neuromyelitis Optica Spectrum Disorders

Phase 1
Waitlist Available
Led By Michael Levy, MD, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 91 days
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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.

Eligible Conditions
  • Neuromyelitis Optica Spectrum Disorders
  • Neuromyelitis Optica (NMO)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow-up visit 91 days after admission
This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-up visit 91 days after admission for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Baseline Expanded Disability Status Score (EDSS)
Follow-Up Expanded Disability Status Score (EDSS)
Safety Assessment and Side Effects

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424
22%
vitreous hemorrhage
17%
worsening of cataract
9%
vitreous syneresis
9%
posterior capsule opacification
4%
cranial nerve VI palsy
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
4%
bradycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BevacizumabExperimental Treatment1 Intervention
Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,563 Previous Clinical Trials
570,079 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,328 Previous Clinical Trials
14,874,615 Total Patients Enrolled
1 Trials studying Neuromyelitis Optica Spectrum Disorders
6 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders
Guthy Jackson Charitable FoundationOTHER
1 Previous Clinical Trials
16 Total Patients Enrolled
~1 spots leftby Nov 2025
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