Celecoxib for Thyroid Eye Disease
Stopped early · Phase 2
Conditions studied: Thyroid Eye Disease
In brief
Thyroid eye disease (TED) is an autoimmune disorder in which the immune system attacks orbital tissues, resulting in characteristic changes in eyelid position, globe position in the orbit, extraocular muscle balance, and optic nerve function. TED is a potentially blinding disease, and current treatments largely consist of nonspecific reduction of inflammation using corticosteroids or radiation therapy. Regardless of treatment, once TED progresses from its inflammatory phase to a more fibrotic, resolution phase, the orbital changes become fixed and can be modified only by surgery. The investigators propose to treat a cohort of patients with active TED using a selective COX-2 inhibitor, celecoxib, and to compare these patients to an observational control group. The investigators hypothesize that celecoxib will reduce the severity of disease and/or prevent progression to proptosis, diplopia, and corneal exposure or compressive optic neuropathy.
Key facts
- Study ID
- NCT02845336
- Run by
- Johns Hopkins University
- People needed
- 7
- Starts
- 2017-03-05
- Expected to finish
- 2019-06-30
- Last updated by the study team
- 2020-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Recent diagnosis of thyroid eye disease (within the past 3 months)
- Have ocular symptoms or signs of TED with a clinical activity score (CAS) of at least 3
You may not qualify if…
- Pregnancy
- Previous treatment with corticosteroid for TED for >2wks
- Previous treatment with orbital radiation for TED
- Impaired renal function
- Impaired hepatic function
- Treatment with antihypertensive medications except beta-blockers
- History of congestive heart failure, cardiac valvular disease, or coronary artery disease
- Allergy to NSAID or previous adverse reaction (ie. GI bleeding)
- Vision loss due to compressive optic neuropathy
Where it is running
- Wilmer Eye Institute, Johns Hopkins University — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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