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

Inclusion Criteria

• •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 randomisation,
• •* 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