Research Title: Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-Comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System with Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration
Sponsor: Genentech, Inc. / Hoffmann-La Roche
Principal Investigator: Robert A. Stoltz, M.D., Ph.D.
Description: Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor [VA]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).
Start Date: October 2018
Project Personnel: Leslie Marcus, CCRC; Caitlin Harrison, CCRC, COA; Stephanie Campbell, CRC, COA
Location(s): Marietta; 833 Campbell Hill Street, Suite 300, Marietta, GA 30060