Carl D. Regillo
CHICAGO — Slow release of concentrated ranibizumab via a surgically implanted port delivery system demonstrated durable disease control in patients with neovascular age-related macular degeneration.
The Ladder trial is an ongoing dose-ranging four-arm phase 2 study designed to characterize the durability and safety of the port delivery system at three different concentrations of ranibizumab, compared with one arm of monthly intravitreal injections of ranibizumab. Primary endpoint was time to first required refill.
“It was the high concentration 100 mg/mL device arm that performed the best with a median time to first refill of 15 months, and 80% of those patients went at least 6 months without requiring a refill,” Carl D. Regillo, MD, reported at Retina Subspecialty Day preceding the American Academy of Ophthalmology annual meeting.
Fifty-eight patients were in the 10 mg/mL arm, 62 patients were in the 40 mg/mL arm, and 59 patients were in the 100 mg/mL arm; 41 patients were in the monthly ranibizumab 0.5 mg arm.
The high concentration dose also performed best regarding vision outcomes, achieving “virtually identical gains” as monthly ranibizumab, Regillo said. Final vision at month 9 in both those arms was 20/32, with the gains well maintained through month 18 in the high concentration group.
Regarding adverse events specifically associated with the port delivery system, “Early on in the study there was a significant problem with regard to postoperative vitreous hemorrhage. In the first 22 patients, the rate of VH was 50%,” Regillo said. However, the study was stopped, the surgical implant procedure was modified to include photocoagulation, and the rate dropped thereafter to just 4% to 5% in the remaining patients enrolled.
The overall rate of other adverse events was low, he said. – by Patricia Nale, ELS
Reference: Regillo CD. Port delivery phase 2 Ladder nAMD study results. Presented at: AAO Subspecialty Day; Oct. 26-27, 2018; Chicago.
Disclosure: Regillo reports receiving research grant support and consulting for Genentech.