Purpose of study:
The purpose of this study is to learn about the safety and effectiveness of an investigational drug called RV 001 in the treatment of thyroid eye disease. An investigational drug is one which has not been approved by the U.S. Food and Drug Administration.
What is Thyroid Eye Disease (TED)?
People with Thyroid Eye Disease (TED) experience eye problems often associated with an overactive thyroid (Graves' disease). The eye problems seen with TED include swelling, redness and discomfort of the eyelids and eye surface, increased tearing, thickening and pulling back of the eyelids, bulging of the eyes, and double vision. TED can threaten sight for a small proportion of patients.
What is involved?
Potential study participants must first be evaluated for eligibility by an ophthalmologist at the Medical College of Wisconsin/Froedtert Hospital Eye Institute. Research participants will make about 17 visits to the Eye Institute over the course of 18 months. After screening tests are performed to confirm eligibility, participants receive the study drug as a series of infusions into a vein. Because no one knows which intervention is best, the study will compare RV 001 to a placebo (an infusion containing no real medicine). About half of the people in this study will receive RV 001 and the other half will receive placebo. Participants will not be told which group they have been assigned to. After the series of infusions, some follow-up visits are completed to perform some more testing for the study.
A total of about 84 people are expected to participate in this study nationally, including about 8 at the Medical College of Wisconsin.
Research volunteers will receive a $75 stipend for each study visit that they complete.