Clinical Trials

MALBEC is a pivotal phase 2b/3, randomised, double-masked, multicentre study evaluating MK-8748 (also known as Tiespectus, EYE201) for the treatment of wet-AMD. Many patients with wet AMD develop persistent or recurrent fluid despite regular anti-VEGF treatment. MK-8748 blocks VEGF and also directly activates Tie2, a key regulator of vessel stability, aiming for better fluid control. MALBEC compares investigational MK-8748 with aflibercept 2 mg, with BCVA change from baseline to Year 1 as the primary efficacy endpoint.

Study participation extends to approximately 96 weeks. Eligible participants receive three monthly loading dose injections, then fixed 8-weekly injections through to week 48, followed by response guided retreatment intervals until week 96.

Study WR42221 is a Phase IIIb, global, multicenter, randomized, visual assessor-masked study designed to assess the efficacy, safety, and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 36 weeks (Q36W) compared with every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD).

Principal Investigator
Professor Adrian Fung