Opthea has completed patient enrolment in an ongoing Phase IIb trial evaluating OPT-302 in combination or compared with ranibizumab for the treatment of patients with wet age-related macular degeneration (AMD).
Enrolment was completed ahead of schedule and included a total of 351 treatment naïve patients at 113 clinical sites in the US, Europe and Israel.
Early completion of registration has preponed the reporting of primary data from the trial to the last quarter of next year.
Opthea is currently screening enrolled patients and is expected to reveal the final number of eligible participants for randomisation over the next few weeks.
Opthea CEO and managing director Dr Megan Baldwin said: “The rate of recruitment in the study is a testament to the need for new therapies that improve vision outcomes for wet AMD patients who receive standard of care anti-VEGF-A therapy.”
The trial features a double-masked, controlled design that aims to evaluate the drug over a period of six months to determine whether it can improve clinical outcomes in treatment-naïve wet AMD patients.
Its primary objective is mean change in early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA).
Secondary objectives include the proportion of patients gaining 15 or more ETDRS BCVA letters, area under the ETDRS BCVA over time curve, and change in central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT).