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

Phase 1

Completed

• Conditions: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder
• Interventions: Drug: Bevacizumab

• Registration Number: NCT01777412
• Lead Sponsor: Johns Hopkins University

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-01-21
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-28
• Study Start: 2013-06
• Primary Completion: 2015-02
• Study Completion: 2015-05
• Results First Submitted: 2015-05-13
• Results First Submitted QC: 2015-05-13
• Results First Posted: 2015-05-29
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-01
• Last Update Posted: 2015-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Baseline Expanded Disability Status Score (EDSS)	Admission to hospital	EDSS; 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 and Side Effects	91 days	Frequency and severity of adverse events and side effects. Serious adverse events are considered those which are life threatening, lead to hospitalization and related to the drug. Side effects are considered minor effects of the experimental drug that do not significantly impact the care of the patient with the experimental drug.
Follow-Up Expanded Disability Status Score (EDSS)	Follow-up visit 91 days after admission	EDSS; 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.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States