At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 108 enrolled
Drug / intervention
Erythropoietin alfa +1 moredrug
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.
Treatment of Optic Neuritis With Erythropoietin: a Randomised, Double-blind, Placebo-controlled Trial
In Brief
A Phase 3 clinical trial evaluating Erythropoietin alfa and Placebo for Optic Neuritis. Completed, enrolled 108 participants across 11 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOptic Neuritis
CountriesGermany
CollaboratorsGerman Federal Ministry of Education and Research
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 2013
Enrollment StartNov 2014
Primary CompletionJun 2018
Study CompletionNov 2019
TodayJul 2026
First PostedOct 14, 2013
Enrollment StartNov 25, 2014
Primary CompletionJun 20, 2018
Study CompletionNov 26, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 12.7 years ago
Interventions
Erythropoietin alfadrug
Placebodrug