Sirolimus vs Corticosteroids in Treatment of Thyroid Eye Disease
ConditionThyroid-Associated Ophthalmopathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHaukeland University Hospital
About this trial
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
Qualifiers
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
Disqualifiers
The participant dont want treatment for active thyroid eye disease or dont want to participate in the study
Decreased vision due to optic neuropathy as defined by a significant decrease in best corrected visual acuity, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months
Corneal decompensation unresponsive to medical management
Previous orbital irradiation or surgery for TED Any steroid use (intravenous [IV] or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of TED. Previous steroid use (IV or oral) with a cumulative dose of <1 g methylprednisolone or equivalent for the treatment of TED and previous use of steroid eye drops is allowed if the corticosteroid was discontinued at least 4 weeks prior to inclusion
Trial design
Treatments tested in this trial
- Sirolimus 1 mg Oral Tablet
- Methylprednisolone
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov