Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis (UVEXATE)

Assistance Publique - Hôpitaux de Paris

Status and phase

Terminated

Phase 4

Conditions

Macular Edema

Ocular Sarcoidosis

Sarcoid-associated Uveitis

Treatments

Drug: Placebo

Drug: Methotrexate

Study type

Interventional

Funder types

Other

Identifiers

NCT00918554

P070140

Details and patient eligibility

About

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

Full description

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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