CompletedPhase 3MS (type not specified)NCT003442532004-004403-37

What it found

No result 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

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

    Vision
  • N/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

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Related trials

History

    1. Started

      Mar 2006

    2. Main results due

      Mar 2011

    3. Finished

      Jan 2012

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