Graves Ophthalmopathy Clinical Trial
Official title:
Treatment of Graves´Ophthalmopathy With Simvastatin (GO-S)
In an investigator initiated multicenter trial (Malmö, Odense, Århus) the investigators aim at evaluating activity of Graves´ophthalmopathy (GO) and progress to severe GO in patients with mild to moderate Graves´ ophthalmopathy treated with simvastatin or no treatment.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | March 30, 2026 |
Est. primary completion date | January 26, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Age 18-70 years 2. Active mild to moderate with at least one sign of mild GO (NO SPECS class 2a and b) with reference to Colour Atlas at EUGOGO website (www.eugogo.eu). Exophthalmos up to 24 mm with a disease duration of <18 months (as recorded by the patient) 3. Graves´ disease with clinical and laboratory euthyroidism after stopping treatment with anti thyroid drugs (ATD), or 2 months treatment with ATD, or euthyroid 6 months after treatment with radioiodine, or euthyroid after total thyroidectomy. Clinical and laboratory euthyroidism is defined as normal fT4, fT3 and TSH below the upper limit of the local reference interval and no clinical symptoms or signs of hyperthyroidism. L-thyroxine is used to achieve euthyroidism during the study period. Exclusion Criteria: 1. Pregnancy or breast-feeding 2. Previous treatment of Graves´ ophthalmopathy 3. Severe Graves ophthalmopathy requiring corticosteroid treatment, retrobulbar irradiation, orbital decompression surgery 4. Current or previous treatment with simvastatin or other statins (within 3 months) 5. Allergy (skin rash or systemic reactions) to statins 6. Congestive heart failure 7. Renal insufficiency (glomerular filtration rate <60 ml/min) 8. ASAT or ALAT > 2.5 times the upper limit of the local laboratory 9. Alcoholism as judged by local criteria 10. Coagulopathy including treatment with warfarin or new oral anti-coagulation drugs 11. Previous or current gastric ulcer 12. Inflammatory bowel disease diabetic retinopathy or nephropathy 13. Trauma within 10 days |
Country | Name | City | State |
---|---|---|---|
Sweden | Dpt. of Endocrinology, SUS Malmö | Malmö |
Lead Sponsor | Collaborator |
---|---|
Lund University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Clinical activity score (CAS) after 6 months | Change in 7-point clinical activity score (CAS) after 6 months treatment with simvastatin or no treatment | 6 months | |
Primary | Number of patients with progression to severe GO during 6 months | Number of patients with progression to severe GO in each group (simvastatin, no treatment) during 6 months treatment | 6 months | |
Secondary | Change in Modified Clinical activity score | Change in Modified clinical activity score after 3 and 6 months treatment with simvastatin or no treatment | 3 and 6 months | |
Secondary | Optical coherence tomography | Evaluation of conjunctival thickness with optical coherence tomography after 3 and 6 months treatment with simvastatin or no treatment | 3 and 6 months | |
Secondary | Quality of life with SF36 | Quality of life after 6 months treatment with simvastatin or no treatment assessed with the SF36 questionnaire | 6 months | |
Secondary | Quality of life with ThyrPro | Quality of life after 6 months treatment with simvastatin or no treatment assessed with the ThyPro questionnaire | 6 months | |
Secondary | Quality of life with GO-QoL | Quality of life after 6 months treatment with simvastatin or no treatment assessed with the GO-QoL questionnaire | 6 months | |
Secondary | TRAb | TRAb after 3 and 6 months treatment with simvastatin or no treatment | 3 and 6 months | |
Secondary | TPO-Ab | TPOAb after 3 and 6 months treatment with simvastatin or no treatment | 3 and 6 months |
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