Actively Recruiting
Sirolimus vs Corticosteroids in Treatment of Thyroid Eye Disease
Led by Haukeland University Hospital · Updated on 2025-09-22
60
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sirolimus vs Corticosteroids in Treatment of Thyroid Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant wants treatment for active thyroid eye disease and agrees to participate
- Clinical diagnosis of Graves' disease with active TED and Clinical Activity Score (CAS) of 4 or higher
- Moderate-to-severe active TED impacting daily life, including symptoms like lid retraction 2 mm, moderate/severe soft tissue involvement, exophthalmos 3 mm above normal, or diplopia
- Symptoms of active TED started within 9 months before joining
- Euthyroid state or mild hypo/hyperthyroidism with thyroid hormone levels within 50% of normal limits
- No immediate need for surgical eye treatment and no planned corrective surgery or irradiation during the study
- Diabetic participants must have stable, well-controlled diabetes with HbA1C below 9.0% and no recent significant medication changes
- Women of childbearing potential must have negative pregnancy tests and agree to use two reliable contraception methods during the trial
- Male participants must be surgically sterile or agree to use barrier contraception if sexually active with females of childbearing potential
- Have received active influenza and pneumococcal vaccines
You will not qualify if you...
- Participant does not want treatment for active thyroid eye disease or does not want to participate
- Vision loss due to optic neuropathy within the last 6 months
- Corneal damage not responding to medical treatment
- Previous orbital irradiation or surgery for TED
- Prior steroid use equivalent to 1 g methylprednisolone for TED; lower doses allowed if stopped at least 4 weeks prior
- Corticosteroid use for other conditions within 4 weeks prior to joining (except topical or inhaled steroids)
- Selenium and biotin supplements not discontinued 3 weeks before screening
- Use of other immunosuppressive or new biologic drugs within 3 months prior to screening
- Use of investigational drugs within 60 days prior to joining or during the trial
- Pre-existing eye disease that complicates study participation
- Bleeding disorders preventing inclusion
- Cancer within past 12 months except certain skin cancers
- Pregnant or breastfeeding women
- Current or recent (past 2 years) drug or alcohol abuse
- Inflammatory bowel disease
- Known allergy to Sirolimus components
- Any other condition the investigator judges as exclusionary
- Previous enrollment in this study
- Infection with HIV, tuberculosis, hepatitis B or C
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Ophthalmology Haukeland University Hospital
Bergen, Hordaland, Norway, 5021
Actively Recruiting
Research Team
H
Hans O ueland, MD PhD
CONTACT
E
Eyvind Rødahl, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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