The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction
Walter Reed National Military Medical Center
Summary
This protocol studies the clinical outcome of patients with active thyroid disease with visually significant signs and symptoms of proptosis, pain, diplopiam lid/orbital edema, or lid/orbital erythema recommended for treatment with teprotumumab infusion (Tepezza®). Patients recommended for treatment will be evaluated by an oculoplastic surgeon (Dr. Eva Chou) and endocrinologist (Dr. Thanh Hoang).
Description
Thyroid eye disease (TED), also known as Graves' orbitopathy or thyroid-associated ophthalmopathy is a rare debilitating autoimmune condition in which immune cells attack the eye muscles and connective tissues within the eye socket, leading to proptosis, pain, diplopia, periorbital and orbital erythema and edema, exposure keratopathy and lagophthalmos, decreased vision, and compressive optic neuropathy. It has an incidence of 1.9 cases per 10,000 population per year. Approximately 25% of patients with autoimmune thyroid disease develop TED within 18 months of diagnosis. Severe optic neuropathy…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * only DOD beneficiaries * adult patients 18 years of age or older * adult patients with proptosis, ocular/orbital pain, diplopia, lid/orbital edema, or lid/orbital erythema associated with autoimmune thyroid disease Exclusion Criteria: * Patients with evidence of compressive optic neuropathy necessitating urgent orbital decompression or external beam radiation * patients with a history of uncontrolled diabetes mellitus * patients with a history/diagnosis of uncontrolled inflammatory bowel disease * patients under age 18 years * patients who are pregnant or trying to bec…
Interventions
- DrugTeprotumumab Injection [Tepezza]
IGF1 monoclonal antibody
Location
- Walter Reed National Military Medical CenterBethesda, Maryland