Chronic Thyroid Eye Disease Study

About the StudyHow Do I QualifyStudy LocationsFAQ

About the Study

The Chronic Thyroid Eye Disease (TED) study is evaluating the safety and potential benefits of teprotumumab in people living with chronic (inactive) TED. The medicine (called teprotumumab) used in this study is currently approved in the U.S. for the treatment of Thyroid Eye Disease.

Please note: This study is for U.S. residents only. For additional information on the Chronic TED study, please visit ClinicalTrials.gov.

Your doctor may have called Thyroid Eye Disease something else when you were diagnosed. Other names for Thyroid Eye Disease include:  Graves' eye disease, Graves' ophthalmopathy, Graves' orbitopathy, thryoid-associated orbitopathy and thyroid ophthalmopathy.

How Do I Qualify?

You may be able to participate in the Chronic TED study if you meet the following requirements:

  • Are ≥18 years old
  • Your eye symptoms started 2-10 years ago
  • You currently have eye bulging, but the bulging has not gotten any worse for at least 1 year
  • You currently have only 1 or none of the following symptoms:
    • Eye pain
    • Eye redness
    • Eyelid swelling
    • Swelling around the eye
  • You have not been treated with teprotumumab for TED
  • You have not had and do not plan to have eye surgery to treat your TED

Important: Other requirements will apply.

If you meet the above qualifications and are interested in applying for this study, please reach out to one of the site locations found here.

People who qualify for the study will receive all study-related treatments and check-ups from the doctor(s) in charge of the study at no cost. Travel costs may be covered for all study participants.


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What will happen during the study?

If you choose to participate, you will be randomly assigned to receive either the study medicine or a placebo. A placebo is a substance that looks like the medicine that is being tested, but it does not have any medicine in it. There is a 2-in-3 chance you will receive the study medicine and a 1-in-3 chance you will receive the placebo. Study participants can expect the following:

  • Visit the study clinic to find out if you qualify for the Chronic TED study.
  • Receive 8 IV (intravenous) infusions of either teprotumumab or placebo once every 3 weeks. An infusion is a medicine that is delivered through a needle that is placed in your arm, called an IV. A medical professional such as a nurse will give you the infusion.
  • Be evaluated by doctors after the 24-week study is complete. Doctors will determine if your TED symptoms have improved at that time.

Study participants who do not see an improvement in their TED symptoms at Week 24 may choose to receive an additional 8 infusions of teprotumumab starting that week.

Your participation is voluntary, and you are free to withdraw at any time for any reason.

Study Clinic Locations

Below is a list of the study location centers and contact information. Please contact the clinic location that is nearest to you. If you are not within driving distance of a clinic, transportation will be arranged for you. Travel costs may be covered for all study participants.

  • California
    • Perlman Medical Offices / University of California San Diego Health
      La Jolla, California 92037
      Contact: Iliana Molina at imolina@health.ucsd.edu
      Principal Investigator: Catherine Liu, M.D.
    • MACRO Trials
      Los Angeles, California 90048
      Contact: Daniela Arias-Perez at dperez2@macrotrials.com
      Principal Investigator: Raymond Douglas, M.D.
  • Colorado
    • University of Colorado Health, Department of Ophthalmology (SOM) Aurora, Colorado 80045
      Contact: Mary Preston at mary.preston@cuanschutz.edu
      Principal Investigator: Prem Subramanian, M.D., Ph.D.
  • Florida
    • Bascom Palmer Eye Institute / University of Miami Health System
      Miami, Florida 33136
      Contact: Maria Esquiabro at mesquiabro@med.miami.edu
      Principal Investigator: Sara Wester, M.D.
  • Missouri
    • Washington University in St. Louis
      Saint Louis, Missouri 63108
      Contact: Eve Adcock at adcockl@wustl.edu
      Principal Investigator: Steven Couch, M.D.
  • Tennessee
    • Hamilton Eye Institute / University of Tennessee Health Science Center
      Memphis, Tennessee 38163
      Contact: Paula McCune at pmccune@uthsc.edu
      Principal Investigator: Brian Fowler, M.D.
  • Texas
    • Neuro-Eye Clinical Trials
      Bellaire, Texas 77401
      Contact: Alonso Prusmack at aprusmack@lfros.com
      Principal Investigator: Rosa Tang, M.D., MPH, MBA
  • Wisconsin
    • Medical College of Wisconsin
      Milwaukee, Wisconsin 52336
      Contact: Erika Nelson at ednelson@mcw.edu
      Principal Investigator: Gerald Harris, M.D.

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Frequently Asked Questions

People participate in clinical research studies for a variety of reasons. Some participate because they want to learn more about their disease. Some volunteer to participate because they want to help researchers learn more about a disease to potentially help them and others in the future.

Clinical research studies follow a specific set of standards and are closely regulated to help ensure the safety of all participants.

You can ask the study team questions at any time before, during and after the study. Before agreeing to participate, make sure that you understand the responsibilities of participating. If you have any concerns about participating, you should feel comfortable discussing them with a member of the study staff or your study doctor at any time.

Yes. Participation in the study is completely voluntary, and you can end your participation at any time, for any reason. If you think you would like to stop participating in the study, talk to the study doctor. If you decide to leave the study early, the study doctor may ask that you return to the study clinic for a final visit to ensure your health and safety. There will be no negative impact on the care you receive.

You can visit any doctor to meet your health needs during the study. You should let your study doctor know that you will be seeing another doctor, and about any other medicine you have been prescribed. All doctors should be aware that you are participating in a clinical study.

No, you will not. The study is “double-masked” so neither you nor the study doctor will know if you will receive the medicine or the placebo.

If you don’t live near one of the study sites listed above, travel to and from one of the approved study sites will be arranged for you throughout the entire study. All travel costs will be covered for you.

No, all study-related medical care and study medicine will be provided at no cost.

Yes, the information you provide will not be shared with anyone without your permission except where required by law or as outlined in the informed consent. "Informed consent" is a document that you would review and sign before participating in the study.

Horizon Therapeutics, the maker of teprotumumab, is conducting the Chronic TED study.

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