Opthea has dosed the first patient in a Phase IIa clinical trial to investigate the safety and efficacy of OPT-302 to treat patients with persistent centre-involved diabetic macular edema (DME).
The randomised, controlled, multicentre, masked trial is set to enrol ~108 DME patients.
Enrolled patients will be randomised in a 2:1 ratio to receive either 2mg of OPT-302 with Eylea (aflibercept) or Eylea monotherapy administered on a monthly basis for three months.
The trial is being conducted at 20 sites across the US and six sites in Australia. It is part of the US Food and Drug Administration’s (FDA) investigational new drug (IND) programme.
Opthea CEO and managing director Dr Megan Baldwin said: “Advancing OPT-302 combination therapy with Eylea into the Phase IIa study for the treatment of DME represents the achievement of another important milestone in the progression of our pipeline, following the continued progress of the Phase IIb study of OPT-302 in combination with Lucentis in patients with wet AMD.
“We remain focused on developing our proprietary novel anti-VEGF-C/D therapy for these expanding eye disease markets, which represent a large unmet medical need.”
The Phase IIa trial follows on from a newly completed Phase Ib dose escalation safety trial of OPT-302 in DME patients.
In the Phase Ib trial, OPT-302 was given via intravitreal injection at three escalating doses, including 0.3mg, 1mg or 2mg in combination with 2mg of Eylea. The combination was found to be well tolerated at all dose levels.
No dose limiting toxicities or treatment-related ocular or systemic adverse events were reported during the trial.
OPT-302 is a soluble vascular endothelial growth factor receptor 3 (VEGFR-3) or ‘Trap’ molecule that blocks the activity of VEGF-C and VEGF-D proteins, which cause blood vessels to grow and leak and eventually lead to the pathophysiology of retinal diseases.