Optic neuritis. MedDRA version: 14.1 Level: LLT Classification code 10030946 Term: Optic neuritis, unspecified System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Solu-Medrol
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Methylprednisolone
CAS Number: 2375-03-3
Other descriptive name: METHYLPREDNISOLONE SODIU
Sponsors
Thor Petersen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To see if early treatment of acute optic neuritis with high-dosis intravenous Solu-medrol, has effect on visual function at follow-up 6 months and 12 months later.;Secondary Objective: Not applicable.;Primary end point(s): 1) Retinal nerve fiber layer thickness. 2) Visual acuity. ;Timepoint(s) of evaluation of this end point: Follow-up at 6 months and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Contrast sensitivity, colour vision, visual field, appearance of optic nerve papil, vascular changes in retina, changes in retina's inner nuclear layer, visual evoked potentials, MRI changes in brain and spinal cord, NMO-IgG in blood, Extended Disability Status Scale (EDSS) score.;Timepoint(s) of evaluation of this end point: 6 and 12 months. | — |
Countries
Denmark
Contacts
Public ContactSclerosis Clinic (Gro H. Dale)
Department of Neurology, Aarhus University Hospital
Outcome results
None listed