Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether methotrexate is a effective corticosteroid sparing agent in the treatment of sarcoid-associated uveitis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Methotrexate; Methylprednisolone; Triamcinolone Acetonide

Criteria

Inclusion Criteria:

• Patients over 18 years old

• Provided written consent for participation in the trial prior to any study-specific procedures or requirements

• Posterior uveitis or panuveitis associated with macular oedema defined as increased macular thickness (more than 250 mm assessed by Stratus TD-OCT or 300 mm with Cirrus SD-OCT ) and/or the presence of cystoid spaces in the macula, and the absence of epiretinal membranes.

• Patient with oral contraception

• Posterior uveitis or panuveitis associated with macular oedema

• Patients with histologically proven sarcoidosis or a presumed sarcoidosis. In case of a non caseating granuloma in biopsy tissues, the patients with presumed sarcoidosis meet at least 2 of the 4 following criteria: typical changes on chest radiography and computed tomography; predominantly CD4 lymphocytosis in bronchoalveolar lavage (BAL) fluid; elevated serum ACE levels; elevated gallium or 5 fluorodeoxyglucose uptake

Exclusion Criteria:

• Patients who do not fulfill the inclusion criteria

• Other causes of uveitis

• Extra ophthalmologic manifestations of sarcoidosis justifying corticosteroids

• Patients previously treated with immunosuppressive agents or corticosteroids of more than 10 mg daily over 15 days.

• Patients with life-threatening conditions

• Chronic hepatopathy or renal failure

• Uncontrolled diabetes mellitus