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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulated dose of prednisone | at 26 weeks | |
| Number of triamcinolone injections | at 26 weeks | |
| Adverse effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sébastien ABAD, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Avicenne - Service de Médecine Interne | Bobigny | 93009 | France | |||
| CHU Michallon de Grenoble |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Placebo | Drug | 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. |
|
| at 26 weeks |
| Percentage of patients with best corrected visual acuity under 0.1, 0.2 and 0. | at 26 weeks |
| Percentage of patients with active anterior and /or posterior uveitis | at 26 weeks |
| Grenoble |
| 38043 |
| France |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |