Celecoxib for Thyroid Eye Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular, Ocular, Endocrine |
| Therapuetic Areas: | Endocrinology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 6/30/2018 |
| Start Date: | March 5, 2017 |
| End Date: | July 2020 |
| Contact: | Nickisa Hodgson, MD |
| Email: | nhodgso2@jhmi.edu |
| Phone: | 410-955-3577 |
An Open Label Trial of Celecoxib in the Treatment of Mild Thyroid Eye Disease
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.
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.
The investigators intend to use celecoxib, a non-steroidal anti-inflammatory drug approved by
the Food and Drug Administration (FDA) for the treatment of pain, osteoarthritis, rheumatoid
arthritis, and ankylosing spondylitis, as a treatment for active TED. In vitro data have
shown that transformation of orbital fibroblasts into adipocytes is mediated by
cyclooxygenase-2 (COX-2), and a case report suggests that COX-2 inhibition can improve TED in
the acute phase. Thus, the investigators intend to evaluate the efficacy of COX-2 inhibition
in the treatment of active TED and its ability to improve both the acute inflammatory signs
and more permanent fibrotic changes of quiescent disease. The investigators will enroll
patients with active TED and treat them for 3 months (a characteristic period of disease
activity) and compare this to standard treatments for mild active TED (observation, with over
the counter interventions such as lubrication with artificial tears) to assess efficacy.
the Food and Drug Administration (FDA) for the treatment of pain, osteoarthritis, rheumatoid
arthritis, and ankylosing spondylitis, as a treatment for active TED. In vitro data have
shown that transformation of orbital fibroblasts into adipocytes is mediated by
cyclooxygenase-2 (COX-2), and a case report suggests that COX-2 inhibition can improve TED in
the acute phase. Thus, the investigators intend to evaluate the efficacy of COX-2 inhibition
in the treatment of active TED and its ability to improve both the acute inflammatory signs
and more permanent fibrotic changes of quiescent disease. The investigators will enroll
patients with active TED and treat them for 3 months (a characteristic period of disease
activity) and compare this to standard treatments for mild active TED (observation, with over
the counter interventions such as lubrication with artificial tears) to assess efficacy.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
1
site
Baltimore, Maryland 21287
Principal Investigator: Timothy J McCulley, MD
Phone: 410-955-3577
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