This study is a Phase IIIb/IV, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (nAMD) that are treatment-naïve in the study eye.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
274
Participants will receive 6-mg faricimab intravitreal (IVT) injections in the study eye according to the dosing regimen for the study arm to which they are randomized.
Change from Baseline in Best-Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 44, 48, and 52
Time frame: Baseline and average of Weeks 44, 48, and 52
Change from Baseline in BCVA Score Averaged Over Weeks 92, 96, and 100
Time frame: Baseline and average of Weeks 92, 96, and 100
Change from Baseline in BCVA Score Over Time
Time frame: From Baseline to Week 100
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time
Time frame: From Baseline to Week 100
Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time
Time frame: From Baseline to Week 100
Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time
Time frame: From Baseline to Week 100
Change from Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44, 48, and 52
Time frame: Baseline and average of Weeks 44, 48, and 52
Change from Baseline in CST Averaged Over Weeks 92, 96, and 100
Time frame: Baseline and average of Weeks 92, 96, and 100
Change from Baseline in CST Over Time
Time frame: From Baseline to Week 100
Percentage of Participants on Different Treatment Intervals at Weeks 52 and 100
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Orange County Retina Medical Group
Santa Ana, California, United States
Florida Retina Institute
Orlando, Florida, United States
Ctr for Retina & Macular Dis
Winter Haven, Florida, United States
Retinal Vitreal Consultants
Chicago, Illinois, United States
University Retina and Macula Associates, PC
Lemont, Illinois, United States
New England Retina Consultants
Springfield, Massachusetts, United States
Sierra Eye Associates
Sparks, Nevada, United States
Retina Associates of New Jersey
Teaneck, New Jersey, United States
Vision Research Center at Eye Associates of New Mexico
Albuquerque, New Mexico, United States
Charles Retina Institute
Germantown, Tennessee, United States
...and 57 more locations
Time frame: Weeks 52 and 100
Incidence and Severity of Ocular Adverse Events
Time frame: From first study treatment to Week 100
Incidence and Severity of Non-Ocular Adverse Events
Time frame: From first study treatment to Week 100