Visual Function Decline Resulting from Geographic Atrophy Results from the Chroma and Spectri Phase 3 Trials
Jeffrey S Heier, Dante Pieramici, Usha Chakravarthy, Sunil S Patel, Sunil Gupta, Andrew Lotery, Eleonora M Lad, David Silverman, Erin C Henry, Majid Anderesi, Elizabeth A Tschosik, Sarah Gray, Daniela Ferrara, Robyn Guymer
OPHTHALMOLOGY RETINA | ELSEVIER INC | Published : 2020
PURPOSE: To assess visual function outcomes to 48 weeks in patients with bilateral geographic atrophy (GA) secondary to age-related macular degeneration included in 2 interventional clinical trials: relationship to baseline lesion size, outcomes by baseline lesion characteristic subgroups, and correlation of visual function outcomes with GA area. DESIGN: The Chroma and Spectri studies (ClinicalTrials.gov identifiers, NCT02247479 and NCT02247531, respectively) were identically designed phase 3, double-masked, multicenter, randomized, sham injection-controlled clinical trials that evaluated intravitreal lampalizumab in GA. PARTICIPANTS: Eligible patients were 50 years of age or older with well..View full abstract
Supported by F. Hoffmann-La Roche Ltd., Basel, Switzerland, which was involved in design and conduct of the studies; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Funding was provided by F. Hoffmann-La Roche Ltd. for third-party writing assistance, which was provided by Anne Nunn, PhD, CMPP, of Envision Pharma Group.