Research Title: A Phase III Randomized, Double-Masked, Parallel Group, Multicenter Study to Compare the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity Between SCD411 and Eylea® in Subjects With Neovascular Age-related Macular Degeneration

Sponsor: Sam Chung Dang Pharm. Co. Ltd.

Principal Investigator: Robert A. Stoltz, MD, PhD

Description: Age-related macular degeneration (AMD) is a leading cause of vision loss in adults. Abnormal blood vessels grow under the macula at the back of the eye, and also leak blood and fluid, which damages and scars the macula, affecting vision. The current standard of care for patients with neovascular (exudative / wet) AMD is anti-vascular endothelial growth factor (anti-VEGF) therapy, which prevents or slows down the growth of the abnormal blood vessels. SCD411 is being developed as a biosimilar to the reference product Eylea® (aflibercept), an anti-VEGF drug. The study aims to prove equivalence of SCD411 to Eylea in adults with wet AMD, and will look at safety, tolerance, effectiveness, immune response and the movement of the drug through the body.

Start Date: September 2020

Recruitment: Enrolling

Project Personnel: Leslie Marcus, CCRC; Caitlin Harrison, CCRC; Stephanie Campbell, CRC; Amber Adams, CRC

Location(s): Marietta; 833 Campbell Hill Street, Suite 300, Marietta, GA 30060

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SamChungDang SCD411-CP101

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