Archway randomised phase 3 trial of ranibizumab port delivery system for nAMD
Holekamp N et al
Ophthalmology, 2022. 129(3): p. 295-307
Review: The Port Delivery System (PDS) with ranibizumab provides continuous delivery of the vascular endothelial growth factor (VEGF) inhibitor from an implanted device into the vitreous for sustained treatment of retinal disease without the need for repeated intravitreal injections.
The Ladder phase 2 study already demonstrated patients with the implant could go without injections for up to 15 months. In this phase 3 study, 248 patients with treated wet AMD received the PDS with a mandated 24-weekly refill procedure. A comparator arm of 167 patients received monthly ranibizumab. In this previously treated cohort, both treatment groups had preserved vision at the study endpoint with a difference of only 0.3 Early Treatment Diabetic Retinopathy Study (ETDRS) letters between the means of the two groups, meaning that PDS treatment can be considered both non-inferior and equivalent.







