CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
Bevacizumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01777412
NCT01777412Phase 1Completed

An Open-label Phase 1b Study of Avastin® (Bevacizumab) for the Treatment of Acute Optic Neuritis and/or Transverse Myelitis in Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD).

Johns Hopkins University·interventional·Posted Jan 28, 2013·Updated Aug 21, 2015

In Brief

A Phase 1 clinical trial evaluating Bevacizumab for Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 28, 2013
Enrollment StartJun 1, 2013
Primary CompletionFeb 1, 2015
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.4 years ago

Interventions

Bevacizumabdrug