Opthea (ASX:OPT) says it has successfully randomised and dosed the first patients in Australia as part of its ongoing Phase 2a clinical study of OPT-302 for persistent centre-involved diabetic macular edema (DME).
The Phase 2a trial is investigating OPT-302, a novel VEGF-C/D ‘Trap’ therapy, in combination with Bayer's PBS-listed EYLEA (aflibercept) for DME and also recently commenced patient dosing at clinical sites in the US in late July 2018.
Professor Paul Mitchell, a study investigator and professor of clinical ophthalmology and eye health at Westmead Clinical School at the University of Sydney, said" “We are delighted to be actively recruiting patients in the Opthea Phase 2a clinical trial in DME. Many patients experience sub optimal responses to ongoing therapy with selective VEGF-A inhibitors. This trial will evaluate whether these patients benefit from the addition of OPT-302 to their standard anti-VEGF-A treatment regimen. It is exciting to evaluate the clinical potential of this novel investigational treatment developed by an innovative Australian biotechnology company in patients with persistent DME.”
The Phase 2a trial is a randomised, controlled, multicenter, masked study evaluating the safety and efficacy of OPT-302 in patients with persistent center-involved DME despite prior anti-VEGFA therapy.
The Phase 2a will enrol approximately 108 DME patients randomised in a 2:1 ratio to either OPT-302 (2.0 mg) with EYLEA, or EYLEA monotherapy administered on a monthly basis for three months.
According to Dr Megan Baldwin, CEO and managing director of Opthea, “The involvement of the Australian clinical trial sites in this DME study further expands the international geographical reach of our OPT-302 clinical research program which is also currently recruiting patients for the Phase 2a study in the US together with our Phase 2b study in treatment-naïve wet AMD patients which is currently ongoing in the US, Israel and eight European countries.”