Abstract
Background
Medical management of thyroid eye disease remains controversial due to a paucity of high quality evidence on long-term treatment outcomes. Glucocorticoids are known to be effective initially but have significant side-effects with long-term use and recrudescence can occur on cessation. Current evidence is conflicting on the efficacy of radiotherapy and non-steroid systemic immunosuppression, and the majority of previous studies have been retrospective, uncontrolled, small or poorly designed.
The Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease (CIRTED) trial was designed to investigate the efficacy of radiotherapy and azathioprine in combination with a standard course of oral prednisolone in patients with active thyroid eye disease.
Methods/design
Patients with active thyroid eye disease will be randomised to receive (i) azathioprine or oral placebo and (ii) radiotherapy or sham-radiotherapy in this multi-centre, factorial randomised control trial. The primary outcome is improvement in disease severity (assessed using a composite binary measure) at 12 months and secondary end-points include quality of life scores and health economic measures.
Discussion
The CIRTED trial is the first study to evaluate the role of radiotherapy and azathioprine as part of a long-term, combination immunosuppressive treatment regime for Thyroid Eye Disease. It will provide evidence for the role of radiotherapy and prolonged immunosuppression in the management of this condition, as well as pilot data on their use in combination. We have paid particular attention in the trial design to establishing (a) robust placebo controls and masking protocols which are effective and safe for both radiotherapy and the systemic administration of an antiproliferative drug; (b) constructing effective inclusion and exclusion criteria to select for active disease; and (c) selecting pragmatic outcome measures.
Trial registration
Current controlled trials ISRCTN22471573
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Details
1 Moorfields Eye Hospital, London, (GRID:grid.439257.e) (ISNI:0000000087265837)
2 University of Bristol, Department of Clinical Science at South Bristol, (GRID:grid.5337.2) (ISNI:0000000419367603); Bristol Eye Hospital, Bristol, (GRID:grid.415175.3) (ISNI:0000000403994581)
3 Bristol Eye Hospital, Bristol, (GRID:grid.415175.3) (ISNI:0000000403994581)
4 Western Eye Hospital, London, (GRID:grid.439733.9)
5 The National Hospital for Neurology and Neurosurgery, Department of Neuroophthalmology, Queen Square, UK (GRID:grid.436283.8) (ISNI:0000000406122631)
6 University College London Hospital, London, (GRID:grid.52996.31) (ISNI:0000000089372257)
7 Manchester Royal Eye Hospital, Manchester, (GRID:grid.416375.2) (ISNI:0000000406412866)
8 Christie Hospital, Manchester, (GRID:grid.415720.5) (ISNI:0000000403998363)
9 Bristol Haematology and Oncology Centre, Bristol, (GRID:grid.410421.2) (ISNI:0000000403807336)
10 West Smithfield, St Bartholomew's Hospital, London, (GRID:grid.416353.6) (ISNI:0000 0000 9244 0345)
11 University of Bristol, Academic Unit of Primary Health Care, Department of Community Based Medicine, Bristol, (GRID:grid.5337.2) (ISNI:0000000419367603)
12 University of the West of England, Centre for Appearance Research, Fishponds, (GRID:grid.6518.a) (ISNI:0000000120345266)
13 University of Bristol, Dorothy Hodgkin Building, Henry Wellcome Laboratories for Integrative Neuroscience and Endocrinology, Bristol, (GRID:grid.5337.2) (ISNI:0000000419367603)