Overview
Locations
Eye Care Centre
Gordon and Leslie Diamond Health Care Centre
Name/Title
Levina Ira, Research Facilitator
Phone
Email Address
Purpose of Study
The purpose of this study is to evaluate the efficacy, safety and tolerability of subcutaneous teprotumumab in participants with moderate-to-severe active thyroid eye disease (TED). TED is an autoimmune disease in which the eye muscles and fatty tissue behind the eye become inflamed. This can push the eyes forward (bulging) or cause redness and swelling. Symptoms can range from mild to sight-threatening. Current treatment options for moderate/severe TED are not optimal (lots of side effects), but teprotumumab holds promise and is being tested for treatment of TED in this trial.
Participants will be randomly assigned to receive teprotumumab or placebo. The study drug will be injected under
the skin every two weeks for 24 weeks. If the eyes do not show any response, participants may choose to receive the study drug for an additional 24 weeks. There will be approximately 15-30 study visits for about one year. Participants will undergo assessments including blood and urine sampling, questionnaires, eye exams and hearing tests.
Eligibility
Visit ClinicalTrials.gov for more information.
Disclaimer
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers and email addresses are provided for obtaining additional information on specific research studies only. If you have specific questions which require clinical expertise, please call your primary care physician.
The purpose of this study is to evaluate the efficacy, safety and tolerability of subcutaneous teprotumumab in participants with moderate-to-severe active thyroid eye disease (TED). TED is an autoimmune disease in which the eye muscles and fatty tissue behind the eye become inflamed. This can push the eyes forward (bulging) or cause redness and swelling. Symptoms can range from mild to sight-threatening. Current treatment options for moderate/severe TED are not optimal (lots of side effects), but teprotumumab holds promise and is being tested for treatment of TED in this trial.
Participants will be randomly assigned to receive teprotumumab or placebo. The study drug will be injected under
the skin every two weeks for 24 weeks. If the eyes do not show any response, participants may choose to receive the study drug for an additional 24 weeks. There will be approximately 15-30 study visits for about one year. Participants will undergo assessments including blood and urine sampling, questionnaires, eye exams and hearing tests.
Visit ClinicalTrials.gov for more information.
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers and email addresses are provided for obtaining additional information on specific research studies only. If you have specific questions which require clinical expertise, please call your primary care physician.
