Port delivery system with ranibizumab in the treatment of diabetic retinopathy without center-involved diabetic macular edema: primary analysis results of the phase 3 Pavilion trial.

Abstract

Purpose : Diabetic retinopathy (DR) is a leading cause of vision loss in working-age adults. There is an unmet need for treatment strategies that sustain the clinical benefits of intravitreal anti–vascular endothelial growth factor (VEGF) in DR, while reducing the overall treatment burden. The Port Delivery System with ranibizumab (PDS) is an innovative drug delivery system for continuous delivery of a customized formulation of ranibizumab into the vitreous that is being evaluated for patients with DR. The phase 3 Pavilion trial is evaluating the efficacy, safety, and pharmacokinetics of PDS 100 mg/mL with refill-exchanges every 36 weeks (PDS Q36W) in patients with DR without center-involved diabetic macular edema (CI-DME).

Methods : Pavilion (NCT04503551) is an ongoing, multicenter, randomized, visual assessor–masked trial, in which eligible patients (planned n = 160) were randomized (5:3) to the PDS Q36W arm (n = ~100) or the clinical observation arm (n = ~60), respectively. Eligible patients were aged ≥ 18 years, with moderately severe or severe nonproliferative diabetic retinopathy (NPDR) (Early Treatment Diabetic Retinopathy Study [ETDRS] Diabetic Retinopathy Severity Scale [DRSS] level 47 or 53) and were DR-treatment naïve in the study eye. Inclusion criteria include diagnosis of diabetes mellitus, glycosylated hemoglobin ≤ 12%, and best-corrected visual acuity of ≥ 69 ETDRS letters (~Snellen 20/40). The prespecified primary endpoint is the proportion of patients with a ≥ 2-step improvement from baseline on the ETDRS-DRSS at week 52.

Results : At the time of abstract submission, the trial is ongoing. However, by the time of the proposed ARVO presentation, primary endpoint data, along with key safety and secondary efficacy endpoints at week 52, will be available and shared.

Conclusions : PDS has the potential to provide the clinical benefits of intravitreal anti-VEGF therapy without the need for frequent intravitreal injections in patients with DR. The primary endpoint and key efficacy and safety data from the Pavilion trial of PDS with refill-exchanges Q36W will be presented.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.