Ignite Creation Date:
2024-05-06 @ 1:19 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01777412
Status:
COMPLETED
Last Update Posted:
2015-08-21
First Post:
2013-01-21
Brief Title:
Efficacy of Bevacizumab Avastin in Treatment of Acute NMO Exacerbations
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
An Open-label Phase 1b Study of Avastin Bevacizumab for the Treatment of Acute Optic Neuritis andor Transverse Myelitis in Neuromyelitis Optica NMO and Neuromyelitis Optica Spectrum Disorder NMOSD
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 1b interventional trial of bevacizumab Avastin to evaluate the tolerabilitysafety and preliminary efficacy of bevacizumab Avastin as add-on therapy for treatment of acute optic neuritis andor 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 tolerabilitysafety and efficacy of adding bevacizumab Avastin to standard of care therapy in improving clinical and radiologic outcomes of acute optic neuritis andor transverse myelitis in neuromyelitis optica and neuromyelitis optica spectrum disorders
Primary Objective To compare the clinical and radiographic outcome following acute optic neuritis andor transverse myelitis in NMONMOSD in patients who receive 1-2 doses of 10 mgkg 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 mgkg 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
Primary Objective To compare the clinical and radiographic outcome following acute optic neuritis andor transverse myelitis in NMONMOSD in patients who receive 1-2 doses of 10 mgkg 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 mgkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None