TEAM-Studie
What it found
We found no results in the registry or in papers.
This trial finished 15 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Interferon beta
- Interferon beta-1a
Interferon alpha/beta receptor agonist
Compared with
- Methotrexate
Dihydrofolate reductase inhibitor
- Methotrexat
What it measured
Main measures
Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12
at month 1,3,6 and 12
VisionN/A
Other measures (3)
Reduction of macular edema (OCT)
at month 1,3,6 and 12
Retina scans (OCT)Reduction intraocular inflammation (2 step change, SUN classification)
at month 1,3,6 and 12
Increase in retinal light sensitivity (fundus controlled perimetry)
at month 1,3 and 12
Who could take part
MS (type not specified) · 18 and over
Inclusion Criteria: * Male and female patients age 18 and over * Active uni- or bilateral non-infectious intermediate uveitis of at least 1 year duration * Visual acuity on the worse eye at least 0.1 (20/200) and maximally 0.6 (20/30) caused by macular edema, defined by foveal thickness ≥ 250 µm * Either primary uveitis or diagnosis of Multiple Sclerosis * Previous treatment with oral corticosteroids in a dose of 0.5 mg per kg bodyweight of prednisone equivalent without sufficient success * Previous treatment with other immunosuppressive drugs is facultative Exclusion Criteria: * Exclusively anterior uveitis * Absence of macular edema * Optic nerve atrophy after neuritis nervi optici * Peri-or intraocular injection of corticosteroids in the previous 3 months * Allergies against any interferon * Depression diagnosed by a psychiatrist * Hepatic disease * Infectious Uveitis * Other auto-immune diseases but MS * Pregnancy, Lactation * Lack of reliable contraception * Patients with metabolic, psychiatric or neoplastic diseases * Active diseases like asthma, psoriasis or inflammatory bowel disease who have to be treated with corticosteroids * primary or secondary immune deficiency * Tuberculosis or other infectious lung diseases * Hepatitis B or C * Life vaccination during the trial duration
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to investigate if interferon beta is superior to the standard treatment with Methotrexate for the treatment of intermediate uveitis and macular edema.
Papers
Loading reviews and guidelines…
Related trials
- INFORM
Running, not recruiting
Still running
- Drug Repurposing Using Metformin for Improving the Therap…
Phase 2 · Status unknown
Missed its main goal
- US PROmyBETAapp2.0: A Study to Learn More About the Medic…
Completed
No result found
- PROmyBETAappGame: a Study to Learn More About the Medicat…
Completed
No result found
- EPID Multiple Sclerosis Pregnancy Study
Completed
No result found
- Comparison Study of PF530 and Betaferon in Healthy Subjects
Phase 1 · Completed
No result found
History
Started
Mar 2006
Main results due
Mar 2011
Finished
Jan 2012
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error