Efficacy and Safety of Efdamrofusp Alfa with Personalized Dosing Intervals in Neovascular Age-Related Macular Degeneration: A Phase II Trial.

ABSTRACT:

Purpose

This study aims to evaluate the efficacy and safety of high-dose efdamrofusp alfa (IBI302, targeting VEGF and complement C3b/4b) with personalized dosing intervals in patients with neovascular age-related macular degeneration (nAMD).

Design

A multicenter, randomized, double-masked, active-controlled, noninferiority phase II trial.

Participants

A total of 132 anti-VEGF naïve or previously treated participants with nAMD were enrolled.

Methods

Eligible participants were randomized (1:1:1) to receive IBI302 6.4 mg, IBI302 8.0 mg, or aflibercept 2.0 mg. Efdamrofusp alfa groups were dosed every 8 weeks (Q8W) or every 12 weeks (Q12W), based on disease activity assessment at week 20, after 4 monthly injections. The aflibercept 2.0-mg group was dosed Q8W, after

SUBMITTER: Li T 

PROVIDER: S-EPMC12494834 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature