Clinical Trial FAQs
What is Teprotumumab?
Dr. Douglas’ study “Teprotumumab for Thyroid-Associated Ophthalmopathy” was recently published in the New England Journal of Medicine. The U.S. Food and Drug Administration (FDA) designated this drug as a “breakthrough” therapy, which is only given to a couple of drugs each year that are so important to changing the field of treatment for patients.
Dr. Douglas lead twenty-two centers as the principal investigator of this trial and represents the largest trial of a biologic ever for Thyroid Eye Disease.A follow-up clinical trial is currently underway and is expected to be completed in 2018.
What does Teprotumumab do?
For those that suffer with bulging of the eyes due to Thyroid Eye Disease, Teprotumumab is the first medicine of its kind that may provide a therapy for avoiding complex surgery and preventing vision loss.
Most patients in the initial trial who received the active drug instead of a placebo had reduced eye bulging, eye pain and swelling and improved quality of life. For some, the therapeutic benefit occurred within six weeks of intravenous infusions of the drug.
How do I know if I qualify for the trial?
Candidates must meet the following basic eligibility criteria:
- 18-75 years of age
- Onset of active Thyroid Eye Disease symptoms within 9 months
- Does not require immediate surgical ophthalmological intervention
- Has not had previous orbital irradiation or surgery for Thyroid Eye Disease
- Must not be pregnant or lactating
If you do not fit these criteria, we can still help! There are other options available to address your concerns. The easiest way to find out more about the Teprotumumab trial is to call us today at 310.657.4302.
I don’t live in Southern California. Can I still participate?
Of course! For those that are located outside of Southern California, Dr. Douglas offers convenient Skype consultations so you can learn more about the trial, discover whether you are a candidate for therapy, or to discuss your concerns. To find out more information, call us today at 310.657.4302.