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New Study to Use Celecoxib (Celebrex®) as Treatment for Thyroid Eye Disease

Dr. McCulley examines scansDr. Timothy McCulley, chief of the neuro-ophthalmology and the ophthalmic plastic and resonstructive surgery divisions at the Johns Hopkins Wilmer Eye Institute, examines MRI scans.

Each year, approximately 1 million Americans are diagnosed with thyroid eye disease, also known as Graves’ disease. Thyroid eye disease is an autoimmune disorder that targets the muscles and soft tissues within the eye. It affects women five to six times more often than men. Many patients have mild to moderate forms of the disease, which does not result in vision loss but can include burdensome symptoms, such as dry and irritated eyes, double vision, and disfigurement. About 10 percent of patients will have sight-threatening disease, which may lead to permanent vision loss, most often caused by compression of the optic nerve, or optic neuropathy.

A limited number of management options exist for those facing optic neuropathy. Nonsurgical treatments include immunosuppression with corticosteroids or other stronger agents and radiation therapy. In the most severe cases, surgery may be required. The surgery, called orbital decompression, involves removing portions of a patient’s eye sockets to allow the eyes to create space for the optic nerve to pass.

“These remedies, although at times very effective, can still fail, and all come with significant risk. They are not as effective as we’d like them to be,” says Timothy McCulley, M.D., associate professor of ophthalmology and chief of the neuro-ophthalmology and ophthalmic plastic and reconstructive surgery divisions at the Johns Hopkins Wilmer Eye Institute. “There’s room for improvement.”

The Oliver and Harriet Sockwell Foundation, which focuses on health and education issues, is funding a study at the Johns Hopkins Wilmer Eye Institute that uses celecoxib, a nonsteroidal, anti-inflammatory drug, as an alternative early treatment for thyroid eye disease.  

The hope is that celecoxib could stop or slow the progression of the disease and help patients avoid surgery altogether.

“The drug’s side effect risk profile is fairly low compared to other medications used to treat Graves’ disease,” says McCulley, who will be the principal investigator of the study. “Theoretically, if you decrease the severity of the disease, fewer people will reach the point where they will require invasive surgery.”

Patients in the early stages of the disease will be enrolled in the study through normal clinical practice and randomized to receive or not receive celecoxib. The study will run for three years.

“Endocrinologists, because the thyroid involves hormones, most commonly refer people with Graves’ disease to us,” McCulley says. “However, if anyone is interested, they should contact the Wilmer Eye Institute call center and schedule a visit to see us.”

Call center information: A Wilmer operator is available to speak to you from 8:30 a.m. to 5 p.m. ET, Monday through Friday, at 410-955-5080You may also call toll free at 888-945-6374.

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