Opthea Ltd (ASX:OPT) has dosed the first patients in Europe and Israel in its Phase 2b trial of OPT-302 for wet age-related macular degeneration (AMD).
This follows the first dosings of OPT-302, a novel VEGF-C/D ‘Trap’ therapy in combination with ranibizumab (Lucentis®), at clinical sites across the US in December 2017.
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Opthea, a developer of novel biologic therapies for the treatment of eye diseases, is staging the Phase 2b trial internationally.
Patients from more than 50 clinical sites in the US are being enrolled and the company is on track to open six trial sites in Israel and more than 50 across eight European countries.
These comprise the UK, France, Poland, Hungary, Spain, Latvia, Italy and the Czech Republic.
All countries and sites have been selected based on experience with conducting ophthalmic clinical trials with anti-VEGF-A therapies.
“Significant progress in trial”
CEO and managing director Dr Megan Baldwin said: “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 in Barcelona, Spain, on March 16.”
351 patients to be enrolled
The Phase 2b trial will enrol 351 patients with wet AMD who have not received prior therapy.
It 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.
Primary analysis of data from the study is anticipated in early 2020.