Mild Graves' orbitopathy
Conditions
Interventions
Group A: pentoxifylline 600 mg twice daily orally for 6 months
Group B: selenium selenite 100 µg twice daily orally for 6 months
Group C: placebo twice daily orally for 6 months
Sponsors
Prof. dr. W.M. Wiersinga
Dept. of Endocrinology and Metabolism
Academic Medical Center
Meibergdreef 9
1105 AZ Amsterdam
T: +31 20 5666071
F: +31 20 6917682
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 of surgery (at least 6 months if I131 is used; 2. Mild Graves' ophthalmopathy (at least 1 sign), with a disease duration of less than 18 months; 3. No past treatment of the ophthalmopathy except for local measures; 4. Age 18-70 years.
Exclusion criteria
Exclusion criteria: 1. NOSPECS class 2c; 2. Proptosis >22 mm; 3. Diplopia in primary or reading position, and/or ocular torticollis; 4. Mono-ocular duction in any direction of less than 20 degrees; 5. Optic nerve involvement; 6. Pregnancy, drugs/alcohol abuse, severe concomitant illness, no informed consent, use of selenium or pentoxifylline containing preparations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in: 1. lid apperture of at least 2 mm; 2. Any of the class 2 signs by at least 1 grade; 3. Proptosis by at least 2 mm; 4. any duction by at least 8 degrees; 5. Improvement of 6 or more points on the GO-QOL scales. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in: 1. The Gorman diplopia score; 2. the 7 first items of the clinical activity score. | — |
Contacts
Public ContactW.M. Wiersinga
Academic Medical Center (AMC), Department of Endocrinology and Metabolism, P.O. Box 22660
Outcome results
None listed