Safety and Tolerability of Suprachoroidal Axitinib Injectable Suspension, for Neovascular Age-related Macular Degeneration; Phase I/IIa Open-Label, Dose-Escalation Trial.

ABSTRACT:

Purpose

To evaluate the safety and tolerability of a single dose of axitinib injectable suspension (CLS-AX), a pan-anti-VEGF tyrosine kinase inhibitor (TKI), administered via suprachoroidal injection in patients with neovascular age-related macular degeneration (nAMD).

Design

Phase I/IIa, open-label, sequential dose escalation.

Participants

Anti-VEGF treatment-experienced patients with active subfoveal choroidal neovascularization secondary to nAMD.

Methods

The study included 4 cohorts (0.03, 0.10, 0.50, and 1.0 mg) of approximately 5 patients each enrolled in a dose-escalating fashion. Enrolled patients received intravitreal aflibercept (2 mg) followed by a single unilateral dose of CLS-AX 1 month later. All patients were followed monthly for 3 months with the

SUBMITTER: Barakat MR 

PROVIDER: S-EPMC11426123 | biostudies-literature | 2025 Jan-Feb

REPOSITORIES: biostudies-literature