The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction

Launched by WALTER REED NATIONAL MILITARY MEDICAL CENTER · Feb 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called teprotumumab (also known as Tepezza®) for patients suffering from thyroid eye disease, which can cause symptoms like bulging eyes, pain, double vision, and swelling around the eyelids. The goal is to see how well this treatment helps improve these symptoms in people who have active thyroid disease. The trial is currently looking for participants who are 18 years or older and are beneficiaries of the Department of Defense. Eligible participants should have noticeable eye problems related to autoimmune thyroid disease, such as bulging eyes or pain.

If you or someone you know is considering joining the trial, you will first be evaluated by a specialist in eye surgery and an endocrinologist (a doctor who treats hormone-related conditions). It's important to note that certain individuals, such as those with severe eye problems needing urgent surgery, uncontrolled diabetes, or inflammatory bowel disease, cannot participate. The trial is open to everyone regardless of gender. Participants can expect to receive infusions of the medication and will be monitored throughout the study to assess how well the treatment works.

Gender

ALL

Eligibility criteria

• 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 become pregnant.