A Phase II Multicenter, Randomized, Double-Masked, Sham-Controlled Study of the Safety and Efficacy of Intravitreal Injections of NGM621 in Subjects with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) (CATALINA)
Sponsor: NGM Biopharmaceuticals, Inc.
Principal Investigator: Kathleen Schildroth, MD
Study Coordinator: Kris Dietzman
To evaluate the efficacy and safety of NGM621 in treatment of patients with geographic atrophy secondary to age-related macular degeneration.
Sham-controlled, intravitreal injection of NGM621 every 4 or 8 weeks for a total of 48 weeks.
Male or female (non-pregnant, non-lactating) subjects ≥ 55 years
Standard luminance BCVA of 34 letters or better using ETDRS charts at the distance of 4 meters (approximately 20/200 Snellen equivalent) in study eye
Clinical diagnosis of GA secondary to AMD:
Total GA area must be ≥ 2.5 and ≤ 17.5 mm²
If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm² (0.5 DA), with the overall area of GA ≥ 2.5 and ≤ 17.5 mm²
Well demarcated GA with no anatomical evidence of current or prior CNV in the study eye
GA secondary to a condition other than AMD in either eye (e.g., monogenetic macular dystrophies like Stargardt disease, cone rod dystrophy, or toxic maculopathies)
Any history of or active choroidal neovascularization (CNV)
Any history of or active bacterial, viral, fungal, or parasitic infection in either eye in the 3 months prior to randomization
Contact Kris Dietzman with questions, 608-263-9035