Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis

Phase 4

Terminated

• Conditions: Macular Edema; Sarcoid-associated Uveitis; Ocular Sarcoidosis
• Interventions: Drug: Methotrexate; Drug: Placebo

• Registration Number: NCT00918554
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-10
• Study First Posted: 2009-06-11
• Study Start: 2009-09
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2013-06
• Last Update Submitted: 2014-05-30
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methotrexate	Methotrexate	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of macular oedema relapses. Every two weeks for five months, the amount of macular oedema will be assessed by Optical Coherence Tomography.	at 26 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with active anterior and /or posterior uveitis	at 26 weeks
Percentage of patients with best corrected visual acuity under 0.1, 0.2 and 0.	at 26 weeks
Cumulated dose of prednisone	at 26 weeks
Number of triamcinolone injections	at 26 weeks
Adverse effects	at 26 weeks

Trial Locations

Locations (2)

Hôpital Avicenne - Service de Médecine Interne; 🇫🇷 Bobigny, France

CHU Michallon de Grenoble; 🇫🇷 Grenoble, France