Clinical Trial Details
Teprotumumab Treatment in Patients With Active Thyroid Eye Disease Official Title:
A Multicenter, Double-masked, Placebo-controlled, Efficacy and Safety Study of an Insulin-like Growth Factor-1 Receptor (IGF-1R) Antagonist Antibody (Fully Human), in Patients with Active Thyroid Eye Disease (TED)
Start Date October 1, 2013
End Date May 1, 2014
| Gender Preference |
|None|| Age Group |
|18 - 75 years|
| Principal Investigator |
|Dr. Erin Shriver|
| Contact Info |
Christine Sinkey, BSN, CCRC (319) 353-8723
|Department of Ophthalmology|
A multicenter study of individuals who have symptoms of thyroid eye disease (also called Graves' orbitopathy) for fewer than six months and have not receieved any treatment for their eye symptoms other than lubricating eye drops. The purpose of this study is to evaluate the effectiveness, safety and tolerability of an investigational medication, insulin-like growth factor-1 receptor (IGF-1R), that may help to alleviate the symptoms of thyroid eye disease in adults, 18 to 75 years of age. Participation will involve up to 18 visits over a period of 19 months. There will also be two scheduled telephone calls between visits.
If you qualify and decide to particpate in the study, you will be assigned to one of two groups at random, similar to flipping a coin. Depending upon your group assignment, you will either be given the investigational medication or an inactive placebo that has no treatment value.
All study related exams, evaluations and either the investigational mediciation or the inactive placebo will be provided to qualified particpants at no cost. Financial compensation may also be provided to those who qualify to cover time and travel expenses related to the study.
To see if you qualify, learn more at GravesEyeDiseaseStudy.com
For further information: http://clinicaltrials.gov/ct2/show/NCT01868997?term=igf+thyroid+eye&rank=1