A Phase 1/2A clinical trial of OPT-302 in patients with wet AMD is currently ongoing under an IND at US clinical sites. The first-in-human multicentre dose-escalation and dose-expansion trial is investigating OPT-302 administered alone or in combination with Lucentis™ on a monthly basis for 3 months by ocular (intravitreal) injection. The trial is being conducted in wet AMD patients who have either not been treated previously (treatment naïve patients) or who have demonstrated a sub-optimal response to prior anti-VEGF-A therapy
Endpoints of the study include assessment of the safety of OPT-302 and preliminary measures of clinical activity, including evaluation of visual acuity using eye charts as well as changes in wet AMD lesions, including fluid and thickness of the tissue at the back of the eye, using sophisticated imaging techniques.
Primary safety data analysis from the Phase 1 dose escalation cohorts is anticipated in 1Q’16. Enrolment of an additional 30 patients in the Phase 2A cohorts is anticipated to commence 2Q’16.