Celecoxib for Thyroid Eye Disease

• Status: Terminated
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Celecoxib; Lubricant Eye Drops

Criteria

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