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 ]

Number of subjects with adverse events, serious adverse events and early discontinuations due to adverse events. Number of subjects with clinical significant abnormal laboratory values, electrocardiograms (pre and post infusions), abnormal vital signs, ophthalmic and physical examinations.


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 ]

Pharmacodynamic measure includes change in Optical Coherence Tomography, Fluorescein Angiography and Stereoscopic color funds photos findings.


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