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

Information source: University Eye Hospital, Freiburg
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Optic Neuritis

Intervention: Erythropoietin alfa (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University Eye Hospital, Freiburg

Official(s) and/or principal investigator(s):
Wolf A. Lagrèze, Prof., Principal Investigator, Affiliation: Eye Hospital, Medical Center - University of Freiburg

Overall contact:
Wolf A. Lagrèze, Prof., Phone: +49 761 270, Ext: 40010, Email: wolf.lagreze@uniklinik-freiburg.de


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Global retinal nerve fibre layer thickness (RNFLT-G)

Low contrast visual acuity (LCVA)

Secondary outcome:

Absolute values of the global retinal nerve fibre layer thickness

Retinal nerve fibre layer thickness in the papillomacular bundle

Retinal nerve fibre layer thickness in the temporal quadrant

Total macular volume

Visual acuity

Contrast sensitivity

Mean visual field defect

Latency [ms] and amplitude [µV] of visual evoked potentials (VEP)

Expanded Disability Status Scale (EDSS) score

Quality of life



Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.


Patients eligible for inclusion in this trial must meet all of the following criteria: 1. Written informed consent obtained according to international guidelines and local laws 2. Male and female patients aged ≥ 18 to ≤ 50 years 3. Patients with ON 4. First symptoms of ON ≤ 10 days prior to the first administration of investigational product 5. High contrast visual acuity (HCVA) of ≤ 0. 5 (decimal system) 6. Adequate OCT measurements available Patients eligible for this trial must not meet any of the following criteria: 1. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial 2. Simultaneous participation in another interventional trial which could interfere with this trial and/or participation in a clinical trial within the last 3 months before enrolment in this trial

3. Refractive anomalies: Hyperopia > 5 dpt, myopia < - 7 dpt, astigmatism > 3 dpt

4. Media opacity 5. Severe papillitis 6. Previous ON 7. Any other optic nerve and retinal disease 8. Pre-existing MS or any other neurological disease 9. Congenital diseases:

- thrombophilia

- phenylketonuria

10. Acquired diseases:

- autoimmune diseases,

- cardiovascular diseases,

- diabetes mellitus,

- uncontrolled hypertension (with blood pressure > 140 / 90 mm Hg (cf. chapter

7. 7.5)),

- any malignancy,

- epilepsy,

- known tuberculosis with ongoing or unknown activity,

- acute gastrointestinal ulceration within the last 3 months prior to


- acute viral, bacterial or fungal infection,

- known infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus, or

Hepatitis C Virus,

- history of colitis ulcerosa, diverticulitis, or acute enteroanastomosis,

- known osteoporosis,

- history of thromboembolic events,

- elevated haemoglobin level (>17 g/dl in men or >15 g/dl in women)

- polycythaemia

- any other significant illness potentially interfering with any trial assessment

or trial treatment 11. Performing semi-professional or professional sporting activities or physical training 12. Pre-treatment with corticosteroids in the last 30 days prior to the onset of optic neuritis 13. Pre-treatment with EPO 14. Known or persistent abuse of medication, drugs or alcohol 15. Active immunization within 2 weeks prior to randomisation 16. Significant surgery within 4 weeks prior to randomisation 17. Blood donation or bloodletting within 4 weeks prior to screening 18. Pre-treatment with immunosuppressive or immunomodulatory agents 19. Persons who are in a relationship of dependence/employment with the sponsor or the investigator This section concerns only female patients who are able to have a child: 20. Current or planned pregnancy; nursing period within 3 months from investigational product administration 21. Unwillingness to use one of the following safe combination methods of contraception within 3 months from investigational product administration to achieve a PEARL index of <1: female condom, diaphragm or coil, each used in combination with a spermicide; hormonal intra-uterine device or hormonal contraception in combination with a mechanical method of contraception

Locations and Contacts

Wolf A. Lagrèze, Prof., Phone: +49 761 270, Ext: 40010, Email: wolf.lagreze@uniklinik-freiburg.de

Charité Berlin, Berlin 10117, Germany; Recruiting

University Medical Center Hamburg-Eppendorf, Hamburg 20246, Germany; Recruiting
Christoph Heesen, Prof. Dr.

Medical Center - University of Freiburg, Eye Hospital, Freiburg, Baden-Wuerttemberg 79106, Germany; Recruiting
Wolf A. Lagrèze, Prof., Phone: +49 761 270, Ext: 40010, Email: wolf.lagreze@uniklinik-freiburg.de

Heidelberg University Hospital, Department of Neurooncology, Heidelberg, Baden-Wuerttemberg 69120, Germany; Recruiting
Ricarda Diem, Prof., Phone: +49 6221 56, Ext: 37774, Email: ricarda.diem@med.uni-heidelberg.de

Tuebingen University Hospital, Tuebingen, Baden-Wuerttemberg 72076, Germany; Recruiting

University Hospital Erlangen, Erlangen, Bayern 91054, Germany; Recruiting

University Hospital Klinikum rechts der Isar, Munich, Munich, Bayern 81675, Germany; Recruiting

University Hospital of Munich, Munich, Bayern 81377, Germany; Recruiting

University Medical Center Goettingen, Goettingen, Niedersachen 37075, Germany; Recruiting

Hannover Medical School, Hannover, Niedersachsen 30625, Germany; Recruiting

Duesseldorf University Hospital, Duesseldorf, Nordrhein-Westfalen 40225, Germany; Recruiting

Essen University Hospital, Essen, Nordrhein-Westfalen 45122, Germany; Recruiting

University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Rheinland-Pfalz 55131, Germany; Recruiting

Additional Information

Study information and useful links in German language

Related publications:

Sühs KW, Hein K, Sättler MB, Görlitz A, Ciupka C, Scholz K, Käsmann-Kellner B, Papanagiotou P, Schäffler N, Restemeyer C, Bittersohl D, Hassenstein A, Seitz B, Reith W, Fassbender K, Hilgers R, Heesen C, Bähr M, Diem R. A randomized, double-blind, phase 2 study of erythropoietin in optic neuritis. Ann Neurol. 2012 Aug;72(2):199-210. doi: 10.1002/ana.23573.

Starting date: November 2014
Last updated: June 9, 2015

Page last updated: August 20, 2015

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