Safety and tolerability of oral vorolanib for neovascular (wet) age-related macular degeneration: a phase I, open-label study.

ABSTRACT:

Objective

To evaluate the efficacy and safety of oral vorolanib for the treatment of neovascular (wet) age-related macular degeneration (nAMD).

Methods

In the dose escalation, participants received ascending doses of oral vorolanib (25-100 mg daily). In the dose expansion, participants received recommended doses (25 and 50 mg daily).

Results

Between March 15, 2015, and January 23, 2019, 41 participants were enrolled in 6 centres in China. At the data cut-off (November 14, 2019), two dose-limiting toxicities (DLTs) were observed during dose escalation (one in the 75 mg cohort and one in the 100 mg cohort). The maximum tolerated dose was not reached. Treatment-related adverse events (TRAEs) occurred in 33 (80.5%) participants, and grade 3 or higher TRAEs occurred in 12

SUBMITTER: Gao Y 

PROVIDER: S-EPMC10564794 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature