End of Study Results Support Use of Port Delivery System for nAMD

Carl Regillo, MD

End of trial results of the phase 2 LADDER study examining the use of a Port Delivery System with ranibizumab(PDS) highlight the potential treatment’s efficacy and safety for treatment of neovascular age-related macular degeneration

Presented by Carl Regillo, director of retina service at Wills Eye Hospital and professor of ophthalmology at Thomas Jefferson University, at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting in San Francisco, results revealed 60% of patients went more than a year without needing a refill and PDS was well tolerated through the end of the study.

PDS is a refillable, indwelling implant that provides patients suffering from neovascular age-related macular degeneration (nAMD) with diffusion-mediated continuous intravitreal delivery of ranibizumab. The phase 2 LADDER study (NCT02510794) enrolled a total of 220 patients who randomized in a 3:3:3:2 ratio to PDS with 10 mg/mL, 40 mg/mL, and 100 mg/mL formulations of ranibizumab or an intravitreal injection of ranibizumab 0.5 mg monthly.

The primary endpoint of the study was the time to first required implant refill. Secondary endpoints were change from baseline in best-corrected visual acuity (BCVA) and central foveal thickness (CFT). Investigators also included safety as a secondary endpoint.

End of study results showed 59.4% of patients in the 100 mg/mL group did not meet refill criteria at month 12 compared to 56% in the 40 mg/mL group, and 28.9% in the 10 mg/mL group. In the 100 mg/mL group, the mean time to first refill was 15.8 months. In the 40 mg/mL and 10 mg/mL groups, mean time was 13.0 months and 8.7 months, respectively.

Additionally, in patients who did require refills the mean time to first refill was 8.8 months. Data presented also revealed the observed mean BCVA change from baseline in the 100 mg/mL group were similar to those observe with monthly intravitreal ranibizumab 0.5 mg. In terms of safety, Regillo remarked they were similar to previous results which were presented previously.

“From a safety standpoint the PDS was very well tolerated throughout the entire study time frame of 22 months on average—up to 38 months in some patients—and no significant changes in the overall safety profile,” Regillo said.

Regillo added at the end of his presentation the results of the study were used to design the phase 3 Archway trial, which Regillo also noted is now fully enrolled.

This study, “Port Delivery System with Ranibizumab (PDS) for Neovascular AMD (nAMD): Ladder Phase 2 Trial End of Study Results,” was presented by Carl Regillo, MD, at AAO 2019.