Moderately severe Graves' orbitopathy
Conditions
Interventions
Treatment with weekly methylprednisolone iv infusions, total dose 2.5, 5.0 or 7.5 gram during 12 weeks
Sponsors
Prof. dr. W.M. Wiersinga
Dept. of Endocrinology and Metabolism
Academic Medical Center
Meibergdreef 9
1105 AZ Amsterdam
T: +31 20 566 6071
F: +31 20 691 7682
e-mail: w.m.wiersinga@amc.uva.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Graves' hyperthyroidism, euthyroid for at least two months by antithyroid drugs or surgery (at least 6 months if I131 is used; 2. Moderately severe Graves' ophthalmopathy defined as having at least one of the following signs: a. class 2b-c b. mono-ocular duction <30 degrees c. diplopia Gorman score grade a-c; 3. Active Graves' ophthalmopathy (CAS 3 or higher out of 7); 4. No past treatment of the ophthalmopathy except for local measures; 5. Age 18-70 years.
Exclusion criteria
Exclusion criteria: 1. CAS <3; 2. Clinically relevant optic nerve involvement; 3. General contra-indications to glucocorticoid infusions; 4. Pregnancy; 5. No informed consent; 6. Viral hepatitis; 7. Liver enzymes increased by a factor 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Efficacy Improvement in: a. lid aperture of at least 3 mm b. 2 or more degrees of class 2 signs c. proptosis by at least 2 mm d. any duction by at least 8 degrees or improvement in diplopia score e. CAS by at least 2 points f. improvement of 6 or more points on the GO-QOL scales. 2. Safety safety score (2 points to each major side effect and 1 point to each minor side effect). | — |
Contacts
Public ContactW.M. Wiersinga
Academic Medical Center (AMC), Department of Endocrinology and Metabolism, P.O. Box 22660
Outcome results
None listed