A Phase 4 interventional study of Methotrexate and Placebo in Sarcoid-associated Uveitis, Ocular Sarcoidosis and Macular Edema, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-02.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Treatment
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.
848 studies on the registry are indexed under Macular Edema; 57 are open to participants now.
This study's enrollment of 7 is below the median of 50 across 624 interventional studies indexed under Macular Edema.
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Drug: Methotrexate
Drug: Placebo
All patients will receive three pulses of methylprednisolone (5 mg/kg) followed by four weeks of prednisone (1 mg/kg daily). After randomization, patients will receive either prednisone (1 mg/kg daily) plus methotrexate (0.3 mg/kg weekly) or prednisone (1 mg/kg daily) plus placebo. Therapies will be administered orally. Corticosteroids will be progressively tapered when macular oedema completely resolve. Unilateral macular oedema relapses will be treated with a single local injection triamcinolone acetonide. Increasing dose of prednisone will be administered in case of bilateral macular oedema relapses.
All patients will receive three pulses of methylprednisolone (5 mg/kg) followed by four weeks of prednisone (1 mg/kg daily). After randomization, patients will receive either prednisone (1 mg/kg daily) plus methotrexate (0.3 mg/kg weekly) or prednisone (1 mg/kg daily) plus placebo. Therapies will be administered orally. Corticosteroids will be progressively tapered when macular oedema completely resolve. Unilateral macular oedema relapses will be treated with a single local injection of triamcinolone acetonide. Increasing dose of prednisone will be administered in case of bilateral macular oedema relapses.
Percentage of macular oedema relapses. Every two weeks for five months, the amount of macular oedema will be assessed by Optical Coherence Tomography.
Time frame: at 26 weeks
Cumulated dose of prednisone
Time frame: at 26 weeks
Number of triamcinolone injections
Time frame: at 26 weeks
Adverse effects
Time frame: at 26 weeks
Percentage of patients with best corrected visual acuity under 0.1, 0.2 and 0.
Time frame: at 26 weeks
Percentage of patients with active anterior and /or posterior uveitis
Time frame: at 26 weeks
The record gives a start of Sep 2009, a primary completion of Aug 2010 and a completion of Aug 2010. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methotrexate
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