WET AMD PHASE 3 PIVOTAL TRIALS
Opthea is planning to initiate two concurrent Phase 3 clinical trials with OPT-302 for the treatment of wet AMD.
The Phase 3 trials, referred to as ShORe and COAST, will be double-masked, sham-controlled trials that enrol treatment-naïve patients and assess the efficacy and safety of 2.0 mg OPT-302 in combination with anti-VEGF-A therapy, compared to standard of care anti-VEGF-A monotherapy. In addition, to understand the durability of OPT-302 treatment effect with less frequent dosing, each trial will compare the clinical efficacy of OPT-302 administered in combination with the applicable VEGF-A inhibitor on an every 4-week and every 8-week dosing regimen.
The primary endpoint of both trials will be the mean change in visual acuity from baseline at week 52. Patients will continue to be dosed until week 96 to further assess long-term safety at week 100.
Opthea intends to initiate patient recruitment into the Phase 3 trials, ShORe and COAST, in the first half of 2021.