PHASE 2A DME DOSE-EXPANSION CLINICAL TRIAL (COMPLETED)
Opthea’s Phase 2a DME clinical trial was a randomized, double-masked, dose expansion trial that enrolled patients diagnosed with persistent center-involved DME despite regular administration of prior anti-VEGF-A monotherapy. These patients are considered to be a difficult-to-treat patient population since they have received prior anti-VEGF-A therapy and experienced a suboptimal clinical response.
The Phase 2a trial was conducted at 53 trial sites in the United States, Israel, Australia and Latvia. Of the 144 patients randomized in the trial, 115 patients conformed sufficiently with the trial protocol and were included in efficacy analyses.
The primary efficacy endpoint of the trial was the clinical response rate, defined as the proportion of patients receiving OPT-302 combination therapy that achieved a ≥5 letter gain in visual acuity at week 12 compared to baseline. Our predefined measure of success was a response rate of greater than or equal to 38% based on historical observations that show limited ability to achieve a ≥5 letter improvement in DME patients on long-term anti-VEGF-A monotherapy.
52.8% of patients treated with OPT-302 combination therapy achieved a ≥ letter improvement in visual acuity at week 12 compared to baseline, meeting the pre-specified primary efficacy endpoint for the trial.
The totality of secondary functional and anatomical responses observed in the patients enrolled in this trial indicate OPT-302 activity.
In addition, the greatest visual acuity gains were observed in patients with a prior-treatment history of aflibercept.