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Enrollment complete in trial of Port Delivery System with ranibizumab
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Patient enrollment has been completed in a phase 3 trial of the Port Delivery System with ranibizumab for wet age-related macular degeneration, Genentech and Roche announced.
The randomized, multicenter, visual assessor-masked, active comparator-controlled Archway clinical trial is the first phase 3 trial of a device used for the continuous delivery of anti-VEGF therapy.
Patients in the trial’s first arm received the PDS implant with refills of 100 mg/mL ranibizumab at fixed 24-week intervals, while its second arm received monthly intravitreal injections of 0.5 mg ranibizumab.
“Wet AMD is a serious, vision-threatening condition, and while effective treatments exist, they require as often as monthly injections, which can be a burden to patients, their caregivers and the health care system — a burden which the PDS aims to address,” Christopher Brittain, global head of Genentech’s ophthalmology clinical development program, said in company correspondence.
Archway’s primary endpoint is non-inferiority in the change from baseline in best corrected visual acuity over weeks 36 and 40. The continuous delivery of ranibizumab made possible by the PDS is intended to reduce the need for frequent eye injections in patients with wet AMD.