Opthea (ASX:OPT), a developer of novel biologic therapies for the treatment of eye diseases, has dosed the first patients in Europe and Israel in its ongoing Phase 2b trial of OPT-302 for wet age-related macular degeneration (AMD).
The study, which is a randomised, controlled clinical trial of OPT-302, a novel VEGF-C/D ‘Trap’ therapy, in combination with Novartis' LUCENTIS (ranibizumab) for wet AMD commenced dosing at clinical sites across the US in December 2017.
“The activation of clinical trial sites in Europe and Israel represents significant progress in our Phase 2b trial. It expands patient recruitment for the study into another nine countries and follows a successful Investigators Meeting held in Barcelona on 16 March,” said Dr Megan Baldwin, CEO and managing director of Opthea.
The Phase 2b study is an international trial, currently enrolling patients from over 50 clinical sites in the US and is on track to open a total of six trial sites in Israel and over 50 trial sites across eight European countries, consisting of the UK, France, Poland, Hungary, Spain, Latvia, Italy and the Czech Republic.
All the countries and sites have been selected based on experience with conducting ophthalmic clinical trials with anti-VEGF-A therapies, said the company.
The company said the investigators meeting convened European and Israeli Investigators and site staff involved in the study and was an opportunity to review data from Opthea’s recently completed Phase 1/2a trial in wet AMD, as well as operational aspects of the Phase 2b study, including the trial protocol and patient eligibility criteria.
Opthea’s Phase 2b trial will enrol approximately 351 patients with wet AMD who have not received prior therapy and is designed to investigate whether the addition of OPT-302 to LUCENTIS therapy over a 6-month dosing period improves visual acuity and anatomical parameters of wet AMD lesions as assessed by imaging techniques.
The primary analysis of the data from the Phase 2b study is anticipated in early 2020.