Abstract
Purpose :
The Port Delivery System with ranibizumab (PDS) is an innovative drug delivery system for the continuous delivery of a customized formulation of ranibizumab into the vitreous. The Portal extension trial (NCT03683251) is evaluating long-term safety and tolerability of the PDS with ranibizumab 100 mg/mL (PDS 100 mg/mL) and includes patients with neovascular age-related macular degeneration (nAMD) who have completed the phase 2 Ladder (NCT02510794) trial. Here we report the efficacy and safety data for the subgroup of Portal patients from Ladder treated with PDS for at least 5 years.
Methods :
Portal is an ongoing, multicenter, open-label extension study enrolling patients who completed the Ladder or Archway (NCT03677934) trials, or who will have participated in the Velodrome trial (NCT04657289). Ladder patients received the PDS (10, 40, or 100 mg/mL) with pro re nata (PRN) refills or monthly intravitreal ranibizumab 0.5 mg injections (monthly ranibizumab). Once rolled over to Portal, patients received PDS 100 mg/mL with fixed refill-exchanges every 24 weeks from day 1. Efficacy outcomes were assessed for Ladder-to-Portal patients treated with PDS 100 mg/mL for at least 5 years. Long-term safety data will be pooled to include any patient in the 10, 40, and 100 mg/mL groups of Ladder who had the PDS for at least 5 years.
Results :
For Ladder-to-Portal patients, best-corrected visual acuity remained stable for 60 months from the Ladder baseline visit (after patients received a mean of 2.9 intravitreal injections) in the prior PDS 100 mg/mL PRN treatment arm (n = 46); mean (95% CI) change from baseline at month 60 was –1.8 (–8.1, 4.4; n = 17) Early Treatment Diabetic Retinopathy Study letters. Center point thickness and central subfield thickness were also overall stable, with mean (95% CI) changes from baseline of –17.5 µm (–52.1, 17.0) and –7.8 µm (–32.9, 17.3), respectively, at month 60.
Conclusions :
Results from Portal suggest that vision and anatomical outcomes with PDS 100 mg/mL are generally stable over 60 months. The long-term safety profile of the PDS will also be reported. Roche/Genentech has voluntarily recalled the PDS (Susvimo) Ocular Implant and Insertion Tool Assembly and paused implantations.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.