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Recruiting Phase 2 NCT04936854

Sirolimus vs Corticosteroids in Treatment of Thyroid Eye Disease

Trial Parameters

Condition Thyroid-Associated Ophthalmopathy
Sponsor Haukeland University Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2023-01-01
Completion 2028-01
Interventions
Sirolimus 1 mg Oral TabletMethylprednisolone

Brief Summary

The purpose of this study is to determine whether Sirolimus is more effective and burdened with less side effects than conventional treatment with corticosteroids in patients with active thyroid eye disease.

Eligibility Criteria

Inclusion Criteria: * The participant want treatment for active thyroid eye disease and is willing to be included in the study * Clinical diagnosis of Graves' disease associated with active TED with a Clinical Activity Score (CAS) ≥ 4 (on the 7-item scale) * Moderate-to-severe active TED (not sight-threatening but has an appreciable impact on daily life), usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia * Onset of active TED symptoms (as determined by participant records) within 9 months prior to inculsion * Participants must be euthyroid with the Graves disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine and free triiodothyronine levels \< 50% above or below the normal limits). * Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irrad

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