Status:
TERMINATED
Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Sarcoid-associated Uveitis
Ocular Sarcoidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00918554
Start Date
September 1 2009
End Date
August 1 2010
Last Update
June 2 2014
Active Locations (2)
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1
Hôpital Avicenne - Service de Médecine Interne
Bobigny, France, 93009
2
CHU Michallon de Grenoble
Grenoble, France, 38043