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

Phase 3

Completed

• Conditions: Optic Neuritis
• Interventions: Drug: Erythropoietin alfa; Drug: Placebo

• Registration Number: NCT01962571
• Lead Sponsor: University Eye Hospital, Freiburg

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 Description

Not available

Study Timeline

• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-14
• Study Start: 2014-11-25
• Primary Completion: 2018-06-20
• Status Verified: 2019-11
• Study Completion: 2019-11-26
• Last Update Submitted: 2019-11-29
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erythropoietin alfa	Erythropoietin alfa	Recombinant human EPO (Epoetin alfa HEXAL®) will be given as an i.v. bolus injection on days 1, 2 and 3. The dosage per day will be 33.000 IU in accordance with previous trials.
Placebo	Placebo	As matched placebo for this study, sterile normal saline (0.9% sodium chloride for i.v. administration) will be used. It will be given as a bolus injection in the same manner as EPO.

Primary Outcome Measures

Name	Time	Method
Global retinal nerve fibre layer thickness (RNFLT-G)	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)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (11)

Heidelberg University Hospital, Department of Neurooncology; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany

University Hospital Klinikum rechts der Isar, Munich; 🇩🇪 Munich, Bayern, Germany

University Hospital Erlangen; 🇩🇪 Erlangen, Bayern, Germany

University Medical Center of the Johannes Gutenberg University Mainz; 🇩🇪 Mainz, Rheinland-Pfalz, Germany

Hannover Medical School; 🇩🇪 Hannover, Niedersachsen, Germany

Tuebingen University Hospital; 🇩🇪 Tuebingen, Baden-Wuerttemberg, Germany

Medical Center - University of Freiburg, Eye Hospital; 🇩🇪 Freiburg, Baden-Wuerttemberg, Germany

University Hospital of Munich; 🇩🇪 Munich, Bayern, Germany

University Medical Center Göttingen; 🇩🇪 Göttingen, Niedersachsen, Germany

Duesseldorf University Hospital; 🇩🇪 Duesseldorf, Nordrhein-Westfalen, Germany

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany