Abstract

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 to provide recommendations that may mitigate such AEs based on clinical trial experience 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 is a permanent, indwelling, and refillable ocular drug delivery system that requires standardized procedural steps, for its insertion and refill-exchange procedures, which have evolved during the PDS clinical program. We describe identified AEs that may arise after implant insertion or refill-exchange procedures, including conjunctival retraction, conjunctival erosion, endophthalmitis, implant dislocation, conjunctival bleb or conjunctival filtering bleb leak, wound leak, hypotony, choroidal detachment, vitreous hemorrhage, rhegmatogenous retinal detachment, cataract, and septum dislodgement.RESULTS: Adverse events related to the PDS were well understood, manageable by trial investigators, and did not prevent patients from achieving optimal outcomes in most cases.CONCLUSIONS: Surgeons using the PDS should be aware of potential ocular AEs and identify them early for optimal management. As with any new surgical procedure, it is important to provide surgeons with appropriate training, to ensure adherence to optimal surgical techniques, and to continually refine the procedure to mitigate complications and improve outcomes.

View details for DOI 10.1016/j.oret.2022.05.011

View details for PubMedID 35589078