Currently Enrolling Study

TED01RV Study for Thyroid Eye Disease

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.

Compensation:

Research volunteers will receive a $75 stipend for each study visit that they complete.

You may be eligible to participate in this study if you meet these criteria.
  1. Aged 18-75 years old
  2. Clinical diagnosis of Graves' disease associated with active TED
    • Fewer than 9 months from the onset of TED
    • Do not need immediate surgery
  3. Patients must be euthyroid or with mild hypo- or hyperthyroidism (FT4 and FT3 levels close to the normal limits).
  4. The following previous treatments are not allowed:
    • Selenium
    • Oral or intravenous (IV) steroids or any other immunosuppressive agent in the past 3 months (oral steroids may be allowed in some cases)
    • Previous orbital irradiation
    • Previous treatment with rituximab (Rituxan© or MabThera©)
  5. No cancer in the past 12 months (successfully treated basal cell cancer of the skin is allowed)
  6. Diabetes must be well controlled
  7. No bleeding or clotting disorders
  8. No pregnant or lactating women
  9. No drug or alcohol abuse
  10. Certain eye conditions that could complicate the study results are not allowed. This is determined by a study doctor
  11. No known hypersensitivity to any of the components of RV 001 or monoclonal antibodies


More Information:

Additional information about the Thyroid Eye Disease study can be found at ClinicalTrials.gov.

IRB Approval:  PRO00020597, 8/19/2013

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Page Updated 10/29/2014
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