Eine monozentrische, randomisierte, kontrollierte Studie zur Untersuchung von Interferon-beta zur Behandlung der Multiplen-Sklerose (MS)-assoziierten und primären Uveitis intermedia im Vergleich zur StandardtherapieA monocentric, randomised, controlled trial for the investigation of Interferon-beta in the treatment of multiple-slerosis (MS)-associated and primary uveitis intermedia compared to the standardized treatment - TEAM-Studie

Phase 1

• Conditions: veitis intermedia with inflammatory macula edema with or without associated Multiple Sclerosis

• Registration Number: EUCTR2004-004403-37-DE
• Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-28
• Study Completion: 2011-03-31
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 34

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

- 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified