Clinical trial NCT00918554: Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis
Official title: Corticosteroid Sparing Effect of Methotrexate in Patients With Sarcoid- Associated Uveitis: A Double Blind, Randomized, Placebo Controlled-study -UVEXATE
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Sarcoid-associated Uveitis
Ocular Sarcoidosis
Macular Edema
Keywords: Sarcoid-associated uveitis
Macular oedema
Methotrexate
Conventional corticosteroids sparing agent.
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-06-11
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Percentage of macular oedema relapses. Every two weeks for five months, the amount of macular oedema will be assessed by Optical Coherence Tomography.
timeFrame: at 26 weeks
Secondary outcomes:
measure: Cumulated dose of prednisone
timeFrame: at 26 weeks
measure: Number of triamcinolone injections
timeFrame: at 26 weeks
measure: Adverse effects
timeFrame: at 26 weeks
measure: Percentage of patients with best corrected visual acuity under 0.1, 0.2 and 0.
timeFrame: at 26 weeks
measure: Percentage of patients with active anterior and /or posterior uveitis
timeFrame: at 26 weeks
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hôpital Avicenne - Service de Médecine Interne
city: Grenoble
country: France
facility: CHU Michallon de Grenoble
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sébastien ABAD, MD
role: PRINCIPAL_INVESTIGATOR
References: