Clinical Trial: Safety and Efficacy Study of Erythropoietin as add-on Therapy of Methylprednisolone to Treat Acute Optic Neuritis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Double Blind, Placebo-controlled Study to Determine the Safety and Efficacy of Erythropoietin as an add-on Therapy of Methylprednisolone in Subjects With Acute Optic Neuritis

Brief Summary: The purpose of this study is to determine the safety and efficacy of erythropoietin as an add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis.

Detailed Summary:

SUMMARY This study is a multicenter, double-blind, placebo-controlled, parallel-group study to determine the safety and efficacy of erythropoietin (Epo) as an add-on therapy to methylprednisolone (Mpred) in subjects with acute autoimmune optic neuritis.

The primary study endpoint is nerve fiber loss in the optical nerve head determined by optical coherence tomography at weeks 4, 8, and 16 compared to baseline.

Further study objectives include visual acuity, visual field perception, optic nerve atrophy determined by magnetic resonance imaging (MRI), and recovery of visual evoked potentials (VEPs).

A number of 40 subjects will be randomized in equal numbers into one of the two treatment groups.

Treatment groups:

Epo or placebo will be administered i.v. at three consecutive days. Epo or placebo is to be given once daily following application of Mpred preferably between 8 and 10 a.m..

Subjects will be randomized to one of the following two treatment groups and dosed as follows:

  • Mpred at a dose of 1000 mg per day on days 1 - 3 given as an i.v. infusion AND 3.3 x 10^4 IU recombinant human Epo per day on days 1- 3 given as an i.v. bolus injection.
  • Mpred at a dose of 1000 mg per day on days 1 - 3 given as an i.v. infusion AND placebo (normal saline) on days 1 - 3 given as an i.v. bolus injection.

Men and women between the ages of 18 and 50, inclusive, diagnosed with acute unilateral optic neuritis with or without prior diagnosis of multiple sclerosis (according to
Sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Current Primary Outcome: nerve fiber loss in the optical nerve head determined by optical coherence tomography at weeks 4,8 and 16 compared to baseline. Measurements at baseline and week 16 are used to calculate estimates for changes and differences between the groups. [ Time Frame: 4 months ]

Original Primary Outcome:

  • The safety and tolerability of Epo in combination with Mpred in subjects with optic
  • neuritis/MS is a primary interest of this study. Additionally, an objective of primary interest is
  • to calculate an estimate for the efficacy of this therapy with respect to nerve fiber loss in the
  • optical nerve head after an episode of acute optic neuritis. Nerve fiber loss will be measured
  • by OCT using the change in retinal nerve fiber layer thickness around the optical nerve head
  • and the change of neural tissue volume in the optical nerve head itself. The measurements will
  • be performed at baseline, week 4, week 8, and week 16. The measurements at baseline and
  • week 16 are used to calculate estimates for changes and differences between the groups.


Current Secondary Outcome: Visual acuity and visual field perception determined at weeks 1, 4, 8, 16 compared to baseline (week 0). MRI measurements of optic nerve atrophy performed at weeks 4, 8 and 16 compared to baseline (week 0) [ Time Frame: 4 months ]

Original Secondary Outcome:

  • Secondary objectives include:
  • Visual acuity determined at weeks 1, 4, 8, and 16 compared to baseline (week 0).
  • Visual field perception determined by automated perimetry at weeks 1, 4, 8, and 16
  • compared to baseline (week 0)
  • Optic nerve atrophy assessed by volumetric MRI data as well as magnetization
  • transfer and/or Diffusion Tensor Imaging (DTI). MRI measurements will be
  • performed at weeks 4, 8, and 16 and will be compared to baseline (week 0).
  • Recovery of latency and amplitude of visual evoked potentials (VEPs).
  • Electrophysiological measurements will be performed at weeks 4, 8, and 16, and will
  • be compared to baseline (week 0).


Information By: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Dates:
Date Received: July 20, 2006
Date Started: August 2006
Date Completion:
Last Updated: September 12, 2012
Last Verified: September 2012