Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease

Not Applicable

Completed

• Conditions: Thyroid Eye Disease (TED); Eye Diseases

• Registration Number: ISRCTN22471573
• Lead Sponsor: niversity of Bristol (UK)

Brief Summary

1. 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18237441 2. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29396245

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-02-01
• Study Completion: 2008-12-01
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified