Opthea has started a Phase lb/lla trial to evaluate the safety and efficacy of OPT-302 in patients with centre-involved diabetic macular edema (DME), the leading cause of blindness in diabetics.
The multi-centre study will be conducted in the US and Australia in a two-part design comprising a Phase lb dose escalation of OPT-302 in combination with the VEGF-A inhibitor Eylea. This will be followed by a Phase lla randomised, controlled dose expansion with treatment allocated in a 2:1 ratio to either OPT-302 with Eylea, or Eylea monotherapy.
Around 117 patients will be enrolled in the trial with persistent central-involved diabetic macular edema, despite having prior anti-VEGF-A therapy.
Primary endpoints of the trial are to examine the safety/tolerability and efficacy of OPT-302 by determining the clinical response rate as defined by the proportion of patients receiving combination OPT-302 and Eylea achieving a ≥ 5 letter gain in visual acuity (VA) compared to baseline at week 12.
The trial includes a number of secondary objectives such as changes in mean VA, diabetic retinopathy severity score and anatomical parameters, including central subfield thickness (CST) and macular volume from baseline to week 12.
Opthea CEO and managing director Dr Megan Baldwin said: “Together with our Phase llb clinical trial in wet age-related macular degeneration (AMD), this study will enable us to more broadly explore the therapeutic potential of OPT-302, which is well-positioned as one of the few combination approaches in development that may address the unmet medical need for patients with these progressive, vision-threatening diseases.”
The company aims to achieve primary analysis data from the Phase lb/lla trial by the first half of 2019.