Multiple sclerosis (MS) is a chronic disease of the central nervous system.Optic neuritis represents one of the most common and frequently the first clinical manifestation of MS. Optic neuritis is mainly characterized by a subacute loss of vision.
Conditions
Interventions
Trade Name: Erypo/Erypo FS
Product Name: Erypo/Erypo FS
Pharmaceutical Form: Injection*
INN or Proposed INN: Epoetin alfa
Other descriptive name: Epo
Concentration unit: IU/ml international unit(s)/mi
Sponsors
IFSgGmbH, Institute for clinical research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of randomization: · Must give written informed consent and authorize the release and use of protected health information (PHI). · Must be 18 to 50 years old, inclusive, at the time of informed consent. · Must have acute unilateral optic neuritis with or without prior diagnosis of MS (according to McDonald criteria). · Symptoms related to optic neuritis must exist for no longer than 10 days prior to inclusion. · Must have had normal visual acuity, normal visual field, normal cup disc ratio of the optic nerve head on both eyes before and no history of optic neuritis. · Must have a decreased visual acuity on the affected eye to 0.5 or less at screening. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Candidates will be excluded from study if any of the following exclusion criteria exist at the time of randomization: Medical history: · Abnormal laboratory results or clinical signs indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurological (other than MS), and/or other major disease. · History of prior optic neuritis on the affected or non-affected eye. · History of squint or amblyopia on either side. · Hyperopia > 3dptr on either side. · Myopia 2dptr on either side. · Horizontal cup disc ratio > 0.5 on either side. · Retinal nerve fiber layer thickness outside normal values (with respect to the OCT data base). · Ocular diseases effecting visual acuity or visual fields (cataract, glaucoma, macula degeneration, diabetic retinopathy, retinal heredodegeneration or others). · History of elevated blood pressure. · History of thrombo-embolic events. · Significant surgery within the 4 weeks prior to randomization. · History of severe allergic or anaphylactic reactions after administration of Epo. · History of malignancy. · History of seizures. · Tuberculosis with ongoing or unknown activity. · Acute gastrointestinal ulceration within the last three months. · Acute virus or bacterial infection. · Diagnosis of phenylketonuria. · Implanted cardiac pacemaker or other non MRI-compatible metallic body implants. · History of drug or alcohol abuse (as defined by the investigator) within 2 years prior to randomization. · Any of the following abnormal blood tests at screening: alanine transaminase/serum glutamate-pyruvate transaminase (AST/SGPT), or aspartate transaminase/serum glutamic-oxaloacetic transaminase (AST/SGOT), gamma-glutamyl-transferase (GGT), or serum creatinine > 2 times the upper limit of normal; hematocrit > the upper limit of normal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The safety and tolerability of Epo in combination with Mpred in subjects with optic neuritis/MS is a primary interest of this study. Additionally, an objective of primary interest is to calculate an estimate for the efficacy of this therapy with respect to nerve fiber loss in the optical nerve head after an episode of acute optic neuritis. Nerve fiber loss will be measured by OCT using the change in retinal nerve fiber layer thickness around the optical nerve head and the change of neural tissue volume in the optical nerve head itself. The measurements will be performed at baseline, week 4, week 8, and week 16. The measurements at baseline and week 16 are used to calculate estimates for changes and differences between the groups.;Secondary Objective: Secondary objectives include: · Visual acuity determined at weeks 1, 4, 8, and 16 compared to baseline (week 0). · Visual field perception determined by automated perimetry at weeks 1, 4, 8, and 16 compared to baseline (week 0) · Optic nerve atrophy assessed by volumetric MRI data as well as magnetization transfer and/or Diffusion Tensor Imaging (DTI). MRI measurements will be performed at weeks 4, 8, and 16 and will be compared to baseline (week 0). · Recovery of latency and amplitude of visual evoked potentials (VEPs). Electrophysiological measurements will be performed at weeks 4, 8, and 16, and will be compared to baseline (week 0). ;Primary end point(s): The primary study endpoint is nerve fiber loss in the optical nerve head determined by optical coherence tomography at weeks 4, 8, and 16 compared to baseline. | — |
Countries
Germany
Outcome results
None listed