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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.
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
No
Medical Center - University of Freiburg, Eye Hospital
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Heidelberg University Hospital, Department of Neurooncology
Heidelberg, Baden-Wurttemberg, Germany
Tuebingen University Hospital
Tübingen, Baden-Wurttemberg, Germany
University Hospital Erlangen
Erlangen, Bavaria, Germany
University Hospital of Munich
Munich, Bavaria, Germany
University Hospital Klinikum rechts der Isar, Munich
Munich, Bavaria, Germany
University Medical Center Göttingen
Göttingen, Lower Saxony, Germany
Hannover Medical School
Hanover, Lower Saxony, Germany
Duesseldorf University Hospital
Düsseldorf, North Rhine-Westphalia, Germany
University Medical Center of the Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, Germany
Start Date
November 25, 2014
Primary Completion Date
June 20, 2018
Completion Date
November 26, 2019
Last Updated
December 2, 2019
108
ACTUAL participants
Erythropoietin alfa
DRUG
Placebo
DRUG
Lead Sponsor
University Eye Hospital, Freiburg
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03401879