Inflammation of the optic nerve and early treatment with prednisolone.
- Conditions
- Optic neuritis.MedDRA version: 14.1Level: LLTClassification code 10030946Term: Optic neuritis, unspecifiedSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-002628-34-DK
- Lead Sponsor
- Thor Petersen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1) Optic neuritis diagnosed by ophthalmologist.
- Visual acuity 6/12 (0,50) or worse, and/or bilateral optic neuritis.
2) Age >18 years.
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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1) Persons not of age, and persons without ability to give informed concent.
2) Pregnant.
3) Patients with a large alcohol consumption.
4) Patients with clinically relevant neurological, cardiovascular, hepatic, endocrine or other severe systemic diseases, that can make implementation of protocol and interpretation of results difficult, or that will put the patient at risk by participating.
5) The following eyediseases: Glaucoma, refraction error of at least 8,0 dioptries, anterior ischaemic opticus neuropathy, retinitis pigmentosa, congenital abnormalities in the optic nerve, previous retinal surgery, previous retinal infection, previous retinal vein occlusion, cataract surgery within the last year and intraocular malign disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method