Actively Recruiting
Treatment of Graves' Ophthalmopathy with Simvastatin (GO-S)
Led by Lund University · Updated on 2024-09-25
80
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
Sponsors
L
Lund University
Lead Sponsor
R
Region Skane
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the activity and progression of Graves' ophthalmopathy (GO) in patients with mild to moderate disease. This multicenter trial compares patients treated with simvastatin to those receiving no additional treatment. The study aims to evaluate changes in disease activity and progression to severe GO, using clinical activity scores and other measures over a six-month period. Participants are randomly assigned to receive either simvastatin 40 mg daily or no treatment for six months. Treatment is prescribed for three months at a time and renewed at follow-up visits. Patients continue their thyroid disease management to maintain normal thyroid hormone levels. Regular assessments by endocrinologists and ophthalmologists monitor eye disease activity and severity using standardized scoring systems, photography, and other tests. During the study, participants attend visits at baseline, three months, and six months for clinical exams, blood tests, eye evaluations including optical coherence tomography, and quality of life questionnaires. Researchers track changes in clinical activity scores and progression of eye disease, as well as laboratory markers and patient well-being. Safety is monitored throughout, and patients may withdraw at any time without affecting their future care.
CONDITIONS
Brief Title
Treatment of Graves´ophthalmopathy with Simvastatin (GO-S)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Active mild to moderate Graves' ophthalmopathy with at least one mild sign
- Exophthalmos up to 24 mm with disease duration under 18 months
- Graves' disease with clinical and lab euthyroidism after stopping or during anti-thyroid drug treatment, or following radioiodine or thyroidectomy
- Normal thyroid hormone levels (fT4, fT3) and TSH below local upper limit
- Signed informed consent
You will not qualify if you...
- Pregnancy or breastfeeding
- Previous treatment for Graves' ophthalmopathy
- Severe Graves' ophthalmopathy requiring corticosteroids, irradiation, or orbital decompression
- Current or recent (within 3 months) treatment with simvastatin or other statins
- Allergy to statins
- Congestive heart failure
- Renal insufficiency (GFR <60 ml/min)
- Elevated liver enzymes (ASAT or ALAT > 2.5 times upper limit)
- Alcoholism
- Coagulopathy or treatment with anticoagulants
- Previous or current gastric ulcer
- Inflammatory bowel disease, diabetic retinopathy, or nephropathy
- Recent trauma within 10 days
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for laboratory and clinical assessments
Duration - 6 months
Participants are randomized to receive simvastatin 40 mg daily or no additional treatment for 6 months to assess effects on Graves' ophthalmopathy.
Visits at baseline, 3 months, and 6 months including clinical control, ophthalmologist assessments, laboratory tests, biobank samples, and quality of life questionnaires
Trial Site Locations
Total: 1 location
1
Dpt. of Endocrinology, SUS Malmö
Malmö, Sweden
Actively Recruiting
Research Team
T
Tereza Planck, MD, PhD
S
Sabina Andersson, MD, PhD
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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