Uveitis intermedia with inflammatory macula edema with or without associated Multiple Sclerosis
Conditions
Interventions
Product Name: Rebif
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 22-
Product Nam
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - male and female patients who are at least 18 years old - active, one or two-sided non-infectious uveitis intermedia for at least one year - visual acuity ranging from at least 0,1 up to 0,6 on the worse eye, due to a macula edema (height of fovea > 180 micrometers) - multiple sclerosis (if there is no primary uveitis intermedia) - previous therapy with corticosteroids for a minimum of 4 weeks with at least 0,5 mg/kg body weight which has not been successful 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - a sole uveitis anterior - no macula-edema - an atrophy of the optic nerve after retro-bulbar-neuritis - a peri- or intraocular injection of corticosteroids in the last 3 months - a prior, unsuccesful, systemic treatment with prednisone - a prior, unsuccesful, systemic treatment with acetacolamid (in order to treat macula edema) - a known allergy against human or recombinant Interferon - a psychiatric diagnosed endogenous depression - diseases of the liver for which hepatotoxic pharmaceuticals cannot be tolerated - infectious kinds of uveitis - all systemic diseases except for MS - pregnancy, lactation - no contraception - additional metabolic or psychiatric diseases or malignant tumor(s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To measure any changes (as an arithmetic mean) of the visual acuity of both eyes;Secondary Objective: The reversion of ocular complications such as macula edema, intraocular inflammatory processes and neovascularisation or changes in the frequency of adverse events;Primary end point(s): N/A | — |
Countries
Germany
Outcome results
None listed