Genentech has initiated a new phase 3 clinical trial investigating Port Delivery System with ranibizumab (PDS) for people with diabetic retinopathy (DR). PDS is a permanent refillable eye implant, approximately the size of a grain of rice, which continuously delivers a customized formulation of ranibizumab over a period of months.
A phase 3, clinical trial that will investigating Port Delivery System (PDS), a permanent refillable eye implant, with ranibizumab for people with diabetic retinopathy (DR) has been initiated, according to a press release from Genentech.
In the multicenter, randomized Pavilion (NCT04503551) study, the efficacy, safety and pharmacokinetics of PDS for the treatment of DR in people without diabetic macular edema will be evaluated by randomizing 160 patients with DR to receive either a PDS arm with fixed 9-month refills or to the comparator observation arm. At 16 months, patients in the comparator arm will be eligible for the PDS implant and will receive refills every nine months.
The primary endpoint is the percentage of patients who achieve a two-step or greater improvement in DR severity from baseline at week 52
“While there are effective therapies to treat diabetic retinopathy, our goal with PDS is to provide patients with the same favorable outcomes with only one treatment every nine months,” Anne Fung, MD, global development lead of PDS at Genentech and a practicing retina specialist in San Francisco, said in a company news release. “It is our hope that PDS, should it be proven to work, could help patients preserve their sight and keep doing the things they love, with fewer interruptions to their daily lives.”
Read the full press release here.