Graves Orbitopathy
Conditions
Interventions
After screening and inclusion, patients will be treated with SOM230 long acting (intramuscular, 60 mgr once monthly) during 12 weeks (i.e. three dosages).
Sponsors
Academic Medical Center Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Moderate – severe GO; 2. Corticosteroids contraindicated due to diabetes mellitus, severe osteoporosis, heart failure, psychosis, infectious diseases or other clinical relevant comorbidities; 3. Corticosteroids refused by patients; 4. Age > 18.
Exclusion criteria
Exclusion criteria: 1. Inability/refusal to give informed consent; 2. Pregnancy; 3. GO (dysthyroid optical neuropathy) necessitating high dose steroids or acute decompression; 4. Abnormal thyroid function (defined as TSH >4.0 mU/l or FT4 21 pmol/l); 5. Pregnancy; 6. Drug abuse and smoking.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A validated overall ophthalmic/endocrine assessment at the CTEC with predefined criteria for success, no change and worsening of GO at 0, 4, 8 and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life (Qol) assessed by the GO-QoL, a validated disease-specific quality-of-life questionnaire to be completed by the patient at 0, 4, 8 and 12 weeks. | — |
Contacts
Public ContactM.R. Soeters
Academic Medical Center (AMC) Department of Endocrinology & Metabolism, F5-162 P.O. Box 22660
Outcome results
None listed