51
Participants
Start Date
April 16, 2018
Primary Completion Date
June 8, 2020
Study Completion Date
February 17, 2021
Teprotumumab
Teprotumumab is a fully human anti-IGF-1R mAb. Teprotumumab will be provided in single-dose 20 mL glass vials as a freeze-dried powder. Each vial of teprotumumab must be reconstituted with 10 mL of water for injection. Reconstituted teprotumumab solution must be further diluted in 0.9% (w/v) sodium chloride (NaCl) solution prior to administration. Teprotumumab will be administered in 100 mL or 250 mL infusion bags (100 mL infusion bags for doses up to 1800 mg and 250 mL infusion bags for doses \> 1800 mg).
Fondazione IRCCS Ca Granda Ospedale Maggiore, Milan
Bascom Palmer Eye Institute, Miami
Hamilton Eye Institute at University of Tennessee Health, Memphis
University Hospital Essen, Department of Ophthalmology, Essen
Kellogg Eye Center at University of Michigan, Ann Arbor
Medical College of Wisconsin, The Eye Institute, Milwaukee
Johannes Gutenberg University Medical Center, Mainz
University of Pisa, Department of Clinical and Experimental Medicine, Pisa
Azienda Ospedaliero Universitaria Pisana, Pisa
Eye Wellness Center, Houston
Cedars-Sinai Medical Center, Los Angeles
Macro, Llc, Beverly Hills
Casey Eye Institute at Oregon Health and Science, Portland
Lead Sponsor
Amgen
INDUSTRY