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.
Pavilion (NCT04503551) is a phase 3, multicenter, randomized study that will evaluate the efficacy, safety and pharmacokinetics of PDS for the treatment of DR in people without diabetic macular edema. In total, 160 patients with DR will be randomized to either the PDS arm with fixed 9-month refills or to the comparator observation arm. Patients in the comparator arm will be eligible for the PDS implant at month 16 and will receive refills every nine months.
The primary endpoint of Pavilion is the percentage of patients who achieve a two-step or greater improvement in DR severity from baseline at week 52, as measured by the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale (ETDRS-DRSS). The study is also designed to see how PDS impacts disease control, visual acuity and anatomic outcomes compared to observation alone.
The intent is to effectively treat DR while reducing the treatment burden of frequent eye injections for patients, who are typically working-age adults.
“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.”
A separate phase 3 trial, Pagoda, is underway studying PDS in patients with diabetic macular edema.
Recently, Genentech announced the phase 3 results of the Archway study in neovascular age-related macular degeneration (nAMD). Results showed PDS patients achieved vision outcomes equivalent to patients receiving monthly ranibizumab eye injections and 98.4% of PDS patients were able to go six months without needing additional treatment.