Thyroid Eye Disease (TED) Eye Diseases Thyroid Eye Disease (TED)
Conditions
Interventions
All the patients receive six months of oral prednisolone and then are randomly assigned to receive one of the following interventions:
1. Radiotherapy and azathioprine
2. Radiotherapy and placebo
3. A
Sponsors
University of Bristol (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Mourits' Clinical Activity Score more than or equal to four (worst eye) or more than two (worst eye) with a history of proptosis (defined as either subjective unilateral proptosis confirmed by asymmetry in exophthalmometry of more than 2 mm or subjective bilateral proptosis) or motility restriction (defined as intermittent, inconstant or constant diplopia grade) which is less than six months long 2. Past or present history of abnormal Thyroid Gland Function (TGF) or a clinical diagnosis of TED made and confirmed by more than two muscle involvement on Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan plus a history of recent onset motility restriction and/or proptosis
Exclusion criteria
Exclusion criteria: 1. Age less than 20 or greater than 75 years 2. Optic neuropathy 3. Mourits? Clinical Activity Score more than four without proptosis or motility restriction 4. Pre-existing glaucoma with a characteristic optic disc appearance and associated visual field defect 5. Use of radioiodine within the last three months 6. Pre-existing diabetes mellitus (not simply steroid-induced disease from recent therapy) 7. Previous adverse event associated with, or contraindication to, either prednisolone or azathioprine 8. Within six months of pregnancy, women planning pregnancy 9. Lactation 10. Haemoglobin concentration, total white cell count or platelet count below the local laboratory's reference range 11. Low, intermediate or high Thiopurine Methyltransferase (TPMT) activity 12. Lymphocyte count less than 0.8 x 10^9/l 13. Abnormal renal function (assessed by urea and creatinine levels above the local laboratory?s reference range) 14. Abnormal liver function, specifically: bilirubin, alanine aminotransferase or alkaline phosphatase concentrations above the local laboratory?s reference range 15. Malignant or pre-malignant (dysplastic) condition within the past five years 16. Previous tuberculosis 17. Shingles within the past three months 18. Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS) 19. Concurrent use of: a. Other immunosuppressive or cytotoxic agents b. Allopurinol 20. Live vaccines within the past three months 21. Previous orbital irradiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: 1. Binary composite clinical outcome measure 2. Ophthalmopathy index Co-primary outcome measure: 1. Clinical activity score | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total Eye Score (TES) 2. Hospital Anxiety and Depression Scale (HADS) score 3. Derriford Appearance scale-short form score 4. Graves? Ophthalmopathy Quality of Life (GO-QoL) score 5. World Health Organisation Brief Quality of Life (WHOQoL) assessment score 6. Open-ended responses to interview questions 7. Health economic measures | — |
Countries
United Kingdom
Outcome results
None listed