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

Patients eligible for inclusion in this trial must meet all of the following criteria:

• Written informed consent obtained according to international guidelines and local laws
• Male and female patients aged ≥ 18 to ≤ 50 years
• Patients with ON
• First symptoms of ON ≤ 10 days prior to the first administration of investigational product
• High contrast visual acuity (HCVA) of ≤ 0.5 (decimal system)
• Adequate OCT measurements available

Patients eligible for this trial must not meet any of the following criteria:

• Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
• 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
• Refractive anomalies: Hyperopia > 5 dpt, myopia < -7 dpt, astigmatism > 3 dpt
• Media opacity
• Severe papillitis
• Previous ON
• Any other optic nerve and retinal disease
• Pre-existing MS or any other neurological disease
• Congenital diseases:

• thrombophilia
• phenylketonuria
• 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
• Performing semi-professional or professional sporting activities or physical training
• Pre-treatment with corticosteroids in the last 30 days prior to the onset of optic neuritis
• Pre-treatment with EPO
• Known or persistent abuse of medication, drugs or alcohol
• Active immunization within 2 weeks prior to randomisation
• Significant surgery within 4 weeks prior to randomisation
• Blood donation or bloodletting within 4 weeks prior to screening
• Pre-treatment with immunosuppressive or immunomodulatory agents
• 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:

• Current or planned pregnancy; nursing period within 3 months from investigational product administration
• 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