Clinical Trial: Treatment of Optic Neuritis With Erythropoietin: a Randomised, Double-blind, Placebo-controlled Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Treatment of Optic Neuritis With Erythropoietin: a Randomised, Double-blind, Placebo-controlled Trial

Brief Summary: This clinical trial aims at preventing visual dysfunction and optic nerve degeneration associated with autoimmune optic neuritis by systemic i.v. administration of 33.000 IU erythropoietin over 3 days. The primary objective is to determine the efficacy of erythropoietin compared to placebo given as add-on to methylprednisolone as assessed by measurements of retinal nerve fibre layer thickness and low contrast visual acuity 6 months after acute optic neuritis.

Detailed Summary:
Sponsor: University Eye Hospital, Freiburg

Current Primary Outcome:

  • Global retinal nerve fibre layer thickness (RNFLT-G) [ Time Frame: 6 months ]
    Determination of the efficacy of erythropoietin compared to placebo given as add-on to methylprednisolone (standard of care) as assessed by measurement of global retinal nerve fibre layer thickness (RNFLT-G) in the affected eye 6 months after randomisation.
  • Low contrast visual acuity (LCVA) [ Time Frame: 6 months ]
    Determination of the efficacy of erythropoietin compared to placebo given as add-on to methylprednisolone (standard of care) as assessed by measurement of low contrast visual acuity (LCVA) in the affected eye 6 months after randomisation.


Original Primary Outcome:

  • Retinal nerve fiber layer thickness [ Time Frame: 6 months ]
    Measured by SD-OCT along a 3.4 mm scan circle concentric to the optic nerve head as defined by the center of Bruchs membrane opening
  • Low contrast visual acuity [ Time Frame: 6 months ]
    Determined by 2.5% contrast Sloan charts


Current Secondary Outcome:

  • Absolute values of the global retinal nerve fibre layer thickness [ Time Frame: 6 months ]
  • Retinal nerve fibre layer thickness in the papillomacular bundle [ Time Frame: 6 months ]
  • Retinal nerve fibre layer thickness in the temporal quadrant [ Time Frame: 6 months ]
  • Total macular volume [ Time Frame: 6 months ]
  • Visual acuity [ Time Frame: 6 months ]
  • Contrast sensitivity [ Time Frame: 6 months ]
  • Mean visual field defect [ Time Frame: 6 months ]
  • Latency [ms] and amplitude [µV] of visual evoked potentials (VEP) [ Time Frame: 6 months ]
  • Expanded Disability Status Scale (EDSS) score [ Time Frame: 6 months ]
  • Quality of life [ Time Frame: 6 months ]
    Determined by NEI-VFQ-25
  • Safety [ Time Frame: Screening until end of study ]
    Assessment of AEs / SAEs


Original Secondary Outcome:

  • Retinal nerve fiber layer thickness at the temporal sector of the optic nerve head [ Time Frame: 6 months ]
  • Retinal nerve fiber layer thickness in the papillo-macular bundle [ Time Frame: 6 months ]
  • Macular volume [ Time Frame: 6 months ]
    Measured by SD-OCT
  • Visual acuity [ Time Frame: 6 months ]
    Measured by ETDRS-charts
  • Contrast sensitivity [ Time Frame: 6 months ]
    Measured by Mars charts
  • Visual field [ Time Frame: 6 months ]
    Measured in the entire visual field using the fast GATE algorithm
  • Vision related quality of life [ Time Frame: 6 months ]
    Determined by NEI-VFQ-25
  • Visually evoked potentials [ Time Frame: 6 months ]


Information By: University Eye Hospital, Freiburg

Dates:
Date Received: September 30, 2013
Date Started: November 2014
Date Completion: December 2018
Last Updated: October 24, 2016
Last Verified: October 2016