Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis

Corticosteroid Sparing Effect of Methotrexate in Patients With Sarcoid- Associated Uveitis: A Double Blind, Randomized, Placebo Controlled-study -UVEXATE

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

Macular oedema remains a significant cause of blindness. Corticosteroids are effective in the treatment of sarcoid-associated macular oedema but more than 50% of relapses occur when corticosteroids are tapered. Methotrexate (MTX) at low dose has been shown to be an effective and safe steroid-sparing agent for lung sarcoidosis and compilation of reported small series of patients with sarcoid-associated uveitis suggest that only 25% of relapses could be achieved with low dose MTX. We decide therefore to test the clinical efficacy of MTX in sarcoid-associated uveitis.

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