Trial to investigate PDS in diabetic retinopathy
Genentech has initiated a phase 3 trial to evaluate the Port Delivery System with ranibizumab to treat diabetic retinopathy in patients without diabetic macular edema, according to company correspondence.
The multicenter, randomized Pavilion trial is expected to enroll 160 patients to be included in the Port Delivery System implant prefilled with ranibizumab (PDS) arm or the comparator observation arm.
Patients in the study arm will receive refills at intervals of 9 months. At 16 months, patients in the comparator arm will be eligible to receive the PDS.
Pavilion’s primary endpoint is the percentage of patients who achieve two-step or more improvement in ETDRS Diabetic Retinopathy Severity Scale score at week 52. Secondary endpoints will measure the impact of PDS on visual acuity and anatomic outcomes.
“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 9 months,” Anne Fung, MD, global development lead of PDS at Genentech, said in the correspondence.
A separate phase 3 trial studying the PDS in patients with diabetic macular edema is also underway.
Editor’s note: On Sept. 2, 2020, this article was corrected to indicate that one study arm includes patients receiving the PDS treatment and the other is a comparator observation arm. The editors regret the error.
Reference:
- NCT04503551. ClinicalTrials.gov.