Management of Key Ocular Adverse Events in Patients Implanted with the Port Delivery System with Ranibizumab.

Purpose: To provide strategies for the management of key ocular adverse events (AEs) that may be encountered with the Port Delivery System with ranibizumab (PDS) in practice and provide recommendations that may mitigate such AEs based on clinical trial experiences and considerations from experts in the field.

Design: Safety evaluation based on the phase 2 Ladder (NCT02510794) and phase 3 Archway (NCT03677934) trials of the PDS.

Methods: The PDS implant is a permanent, indwelling, and refillable ocular drug delivery system that requires standardized procedural steps for its insertion and refill-exchange procedures, which evolved during the PDS clinical program.

End-of-Study Results for the Ladder Phase 2 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration.

Purpose: 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).

Design: Multicenter, randomized, active treatment-controlled phase 2 clinical trial.

Participants: Patients diagnosed with nAMD with a documented response to anti-vascular endothelial growth factor treatment who received study treatment (N = 220).