Treatment of an inflammation of the optic nerve with a medical drug (Erythropoietin)
- Conditions
- Optic NeuritisMedDRA version: 20.0Level: PTClassification code 10030942Term: Optic neuritisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-002515-10-DE
- Lead Sponsor
- niversity Medical Center Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 108
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 optic neuritis
4. First symptoms of optic neuritis = 10 days prior to the first administration of investigational product
5. High contrast visual acuity (HCVA) of = 0.5 (decimal system)
6. Adequate Optical Coherence Tomography (OCT) measurements available
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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),
• 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 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
Additional specific exclusion criteria for 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 6 months after randomisation;Primary end point(s): 1) RNFLT-G-12 of contralateral healthy eye at baseline minus RNFLT-G-12 of the affected eye 6 months after randomisation<br>2) low contrast visual acuity (LCVA) in the affected eye 6 months after randomisation;Main Objective: Determination of the efficacy of erythropoietin compared to placebo given as add-on to methylprednisolone (standard of care) as assessed by measurements of global retinal nerve fibre layer thickness (RNFLT-G) and low contrast visual acuity (LCVA) 6 months after randomisation;Secondary Objective: Comparison of efficacy of erythropoietin compared to placebo given as add-on to methylprednisolone with respect to RNFLT and other functional changes 6 months after randomisation<br>and <br>assessment of safety in both treatment arms<br>
- Secondary Outcome Measures
Name Time Method