Clinical Trial Evaluating Teprotumumab for Thyroid Eye Disease

Study Title: Treatment of Graves’ Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis with Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study (OPTIC)

ClinicalTrials.gov Identifier: NCT03298867 (view full study details, including inclusion criteria and locations, on ClinicalTrials.gov)

Study Phase: Phase 3

Status: Currently enrolling patients

Overview: OPTIC is a confirmatory, randomized, placebo-controlled, double masked clinical trial evaluating Horizon Pharma’s development-stage medicine teprotumumab. The purpose of the clinical trial is to investigate the efficacy, tolerability, and safety of teprotumumab, in comparison to placebo, in the treatment of people living with moderate-to-severe active thyroid eye disease. The study will enroll 76 patients across 11 centers in the United States, Germany and Italy.

Thyroid eye disease is an eye condition in which the eye muscles and fatty tissue behind the eye become inflamed. This can cause proptosis, where the eyes are pushed forward causing “staring” or “bulging” eyes and the eyes and eyelids become swollen and red. In some cases there is swelling and stiffness of the muscles that move the eyes so that they are no longer in line with each other, or the eyelids are unable to close.