CATALINA

Actively Recruiting // Age-related Macular Degeneration // Clinical Trials // Geographic Atrophy // Kathleen Schildroth // Dec 01 2020

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

Study objective:

To evaluate the efficacy and safety of NGM621 in treatment of patients with geographic atrophy secondary to age-related macular degeneration.

Study design:

Sham-controlled, intravitreal injection of NGM621 every 4 or 8 weeks for a total of 48 weeks.

Inclusion criteria:

  • 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

Exclusion criteria:

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)

Both eyes:

  • 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

For more information about this study, visit clinicaltrials.gov.