Opthea has dosed the first patients in Europe and Israel for an ongoing Phase IIb trial of OPT-302 in combination with ranibizumab (Lucentis) to treat wet age-related macular degeneration (AMD).
Last December, Opthea started dosing patients for the randomised, controlled trial at various clinical sites across the US.
The trial is currently enrolling patients from over 50 clinical sites in the US and aims to open a total of six trial sites in Israel, as well as 50 sites across eight European countries, including the UK, France, Poland, Hungary, Spain, Latvia, Italy and the Czech Republic.
Based on successful regulatory interactions between Opthea and each of the participating European countries’ regulatory agencies via the European Voluntary Harmonisation Process (VHP), Ministry of Health in Israel and the US Food and Drug Administration (FDA), Opthea started randomisation and dosing of patients.
Opthea CEO and managing director Dr Megan Baldwin said: “The activation of clinical trial sites in Europe and Israel represents significant progress in our Phase IIb trial.
“It expands patient recruitment for the study into another nine countries and follows a successful Investigators Meeting held in Barcelona, Spain, on 16 March.”
The trial will enrol approximately 351 patients with wet AMD who have not received prior therapy. It will evaluate whether the addition of OPT-302 to Lucentis therapy over a six-month dosing period improves visual acuity and anatomical parameters of wet AMD lesions, as measured by imaging techniques.
Primary analysis of the data from the trial is expected to be available in early 2020.
OPT-302 is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) or ‘Trap’ molecule that blocks the activity of two proteins, including VEGF-C and VEGF-D.
The proteins cause blood vessels to grow and leak, which lead to the pathophysiology of retinal diseases.