drugset / Trial / NCT02845336

Celecoxib for Thyroid Eye Disease

NCT02845336 ↗

Phase 2 Terminated 7 enrolled Johns Hopkins University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-03-05
Primary completion
2019-06-30
Completion
2019-06-30

Outcome

Outcome not reported

Stopped (Enrollment): “Poor enrollment”

Drugs

EvaluationDrugModalityDoseRoute
Subject Celecoxib Other / unclassified 100 mg Oral