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