Genentech and Roche have initiated a new phase 3 clinical trial investigating the Port Delivery System with ranibizumab (PDS) in people with diabetic macular edema (DME). The PDS is an investigational first-of-its-kind refillable eye implant designed to continuously release a customized formulation of ranibizumab over a period of months.
Pagoda (NCT04108156) is a phase 3, multicenter, randomized, active-comparator, non-inferiority study that will evaluate the efficacy, safety and pharmacokinetics of the PDS for the treatment of DME. In total, nearly 550 patients with DME will be randomized to receive either the PDS 100 mg/mL refilled at fixed 6-month intervals or monthly intravitreal injections of ranibizumab 0.5 mg. The primary endpoint of Pagoda is the change in Best-Corrected Visual Acuity (BCVA) from baseline averaged over weeks 48 and 50. The PDS is an investigational drug delivery system that includes an implant, ancillary devices, and ranibizumab. The PDS allows continuous delivery of ranibizumab and thus is intended to reduce the burden of frequent eye injections by allowing people with DME to potentially go several months before needing a refill of the implant, and to address under-treatment that could lead to vision loss.
“We are excited that patient enrollment in Pagoda has begun. This is the first clinical trial to investigate the PDS in DME, a serious retinal condition that affects nearly 750,000 people in the U.S. and is the leading cause of blindness among working aged adults,” Anne Fung, MD, global development lead of the PDS at Genentech and a practicing retina specialist in San Francisco, said in a Genentech statement. “While we have effective therapies for DME, the treatment burden on patients can be high, with as often as monthly injections. With the PDS, our hope is that these patients may be able to go up to 6 months between treatments.”
The PDS is also being studied in patients with wet age-related macular degeneration (AMD) in the phase 3 Archway trial, which recently completed patient enrollment. The Archway trial was initiated based on the results of the phase 2 Ladder study, announced last year, which showed that nearly 80 percent of patients in the PDS 100 mg/mL arm were able to go 6 months or longer between the implant of the device and the first required refill.