Clinical Trial: A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema (DME)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 1, Open-Label Safety and Pharmacodynamic Study of RV001, an Insulin-Like Growth Factor-1 Receptor (IGF-1R) Antagonist, Administered by Intravenous (IV) Infusion in Patients With Diabetic
Brief Summary: A Phase 1 Study to evaluate the Safety of teprotumumab in Patients with Diabetic Macular Edema.
Detailed Summary: A Phase 1, Open-Label Safety and Pharmacodynamic Study of RV 001, an Insulin-Like Growth Factor-1 Receptor (IGF-1) Antagonist, Given By IV Infusion in Patients with Diabetic Macular Edema (DME).
Sponsor: River Vision Development Corporation
Current Primary Outcome: Safety of RV001in subjects with Diabetic Macular Edema [ Time Frame: Change from Baseline to Week 9 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Safety of RV001in subjects with Diabetic Macular Edema [ Time Frame: Change from Baseline to Week 9 ]
Original Secondary Outcome: Same as current
Information By: River Vision Development Corporation
Dates:
Date Received: March 27, 2014
Date Started: October 2014
Date Completion:
Last Updated: August 17, 2016
Last Verified: August 2016