To report the end of study results from the Ladder clinical trial of the Port Delivery System with ranibizumab (PDS) for the treatment of neovascular age-related macular degeneration (nAMD).
Multicenter, randomized, active treatment-controlled phase 2 clinical trial.
Patients diagnosed with nAMD with a documented response to anti-vascular endothelial growth factor treatment who received study treatment (N = 220).
Patients were randomized 3:3:3:2 to treatment with the PDS filled with ranibizumab 10 mg/mL, 40 mg/mL, and 100 mg/mL formulations or monthly intravitreal ranibizumab 0.5 mg injections.
End of study results for the time to first meeting refill criteria (first refill), mean change from baseline for best-corrected visual acuity (BCVA) and central foveal thickness (CFT), and safety.
At study end, the mean (range) time on study was 22.1 (10.8-37.6) months for all PDS patients. Median time to first refill was 8.7, 13.0, and 15.8 months, and 28.9%, 56.0%, and 59.4% of patients went 12 months or longer without meeting refill criteria in the PDS 10 mg/mL, 40 mg/mL, and 100 mg/mL treatment arms, respectively. At month 22, the observed mean BCVA change from baseline was ‒4.6, ‒2.3, +2.9, and +2.7 Early Treatment Diabetic Retinopathy Study letters in the PDS 10 mg/mL, 40 mg/mL, 100 mg/mL and monthly intravitreal ranibizumab 0.5 mg treatment arms, respectively. At month 22, the observed mean CFT change from baseline was similar in the PDS 100 mg/mL and monthly intravitreal ranibizumab 0.5 mg treatment arms. No new safety signals were detected during the additional follow-up.
Over a mean of 22 months on study, vision and anatomic outcomes were comparable between the PDS 100 mg/mL and monthly intravitreal ranibizumab 0.5 mg arms, with a lower total number of ranibizumab treatments with the PDS. The Ladder end of study findings were consistent with the primary analysis, and the PDS was generally well tolerated throughout the entire study period. The PDS has the potential to reduce treatment burden in patients with nAMD while maintaining vision.
Copyright © 2020. Published by Elsevier Inc.