Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease

• Register: ISRCTN
• Last refreshed on: 26 February 2018
• Main ID: ISRCTN22471573
• Date of registration: 01/02/2006
• Prospective Registration: No
• Primary sponsor: University of Bristol (UK)
• Public title: Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease
• Scientific title: Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease
• Date of first enrolment: 01/01/2006
• Target sample size: 100
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN22471573
• Study type: Interventional
• Study design: Factorial randomised controlled trial (Treatment)
• Phase: Not Specified

Countries of recruitment

United Kingdom

Contacts

• Name: Richard Lee

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Thyroid Eye Disease (TED)
Eye Diseases
Thyroid Eye Disease (TED)

Intervention(s)

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. Azathioprine and placebo
4. Control: placebo and placebo

Primary Outcome(s)

Primary:
1. Binary composite clinical outcome measure
2. Ophthalmopathy index

Co-primary outcome measure:
1. Clinical activity score

Secondary Outcome(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

The National Eye Research Centre, Bristol (UK), Special trustees of Moorfields Eye Hospital (UK), The Charitable Trusts for the United Bristol Hospitals (UK)

Ethics review

Status:
Approval date:
Contact:

Central & South Bristol Research Ethics Committe (reference: 05/Q2006/62), approval gained 5th May 2005 (amendment to inclusion and exclusion criteria approved on the 2nd June 2006).

Results

• Results available: Yes
• Date Completed: 01/12/2008