TENAYA and LUCERNE: Rationale and Design for the Phase 3 Clinical Trials of Faricimab for Neovascular Age-Related Macular Degeneration.

ABSTRACT:

Purpose

To describe the design and rationale of the phase 3 TENAYA (ClinicalTrials.gov identifier, NCT03823287) and LUCERNE (ClinicalTrials.gov identifier, NCT03823300) trials that aimed to assess efficacy, safety, and durability of faricimab, the first bispecific antibody for intraocular use, which independently binds and neutralizes both angiopoietin-2 and vascular endothelial growth factor-A (VEGF-A) versus aflibercept in patients with neovascular age-related macular degeneration (nAMD).

Design

Identical, global, double-masked, randomized, controlled, phase 3 clinical trials.

Participants

Adults with treatment-naïve nAMD.

Methods

These trials were designed to evaluate patients randomized to receive faricimab 6.0 mg up to every 16 weeks after 4 initial every-

SUBMITTER: Khanani AM 

PROVIDER: S-EPMC9559073 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature