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  • Port Delivery System implant is noninferior to intravitreal ranibizumab for neovascular AMD

    Retina/Vitreous

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    Review of: Archway randomized phase 3 trial of the Port Delivery System with ranibizumab for neovascular age-related macular degeneration

    Holekamp N, Campochiaro P, Chang M, et al. Ophthalmology, in press

    Archway is a phase 3 randomized, active-comparator, open-label trial that assessed the efficacy and safety of the Port Delivery System (PDS) implant vs. intravitreal ranibizumab for the treatment of neovascular AMD.

    Study design

    A total of 415 patients 50 years or older who had received at least 3 anti-VEGF injections in the past 6 months were randomized 3:2 to receive either the PDS with ranibizumab 100 mg/mL with fixed 24-week (Q24W) refills/exchanges or intravitreal ranibizumab 0.5-mg injections every 4 weeks (monthly ranibizumab). The main outcome was change in best corrected visual acuity (BCVA) from baseline averaged over weeks 36 and 40 of the study.

    Outcomes

    The adjusted mean change in BCVA score from baseline was +0.2 letters in patients receiving PDS Q24W and +0.5 letters in patients receiving monthly ranibizumab. At week 40, the proportion of patients with loss of ≥15 ETDRS letters was similar between treatment arms. With these results, PDS Q24W was deemed both noninferior and equivalent to monthly ranibizumab. Prespecified ocular adverse events of interest in the PDS Q24W–treated arm included vitreous hemorrhage (5.2% of patients), conjunctival erosion (2.4%), conjunctival retraction (2.0%), and endophthalmitis (1.6%). In total, 19.0% of patients given PDS Q24W and 6.0% of patients given monthly ranibizumab experienced an ocular adverse event.

    Limitations

    Archway was designed as a noninferiority trial, which is typical for the evaluation of a new treatment agent or delivery method. Therefore, one limitation of this study was the lack of an extended treatment interval (e.g., treat-and-extend) comparator arm. Also, the comparator arm was monthly ranibizumab only, and other anti-VEGF agents were not available for comparison. This prevents a full assessment of the durability gained with use of PDS over currently available treatment options.

    Clinical significance

    Archway met its primary objective as PDS Q24W demonstrated noninferior and equivalent efficacy to monthly ranibizumab. The use of a surgical implant with the promise of increased treatment durability represents a paradigm shift in the treatment of neovascular AMD. The increased rate of certain prespecified complications seen in the PDS arm, such as vitreous hemorrhage, compared with rates in the intravitreal injections arm should be taken into account and discussed during any informed consent process. However, more surgical experience with device implantation may help reduce PDS-related complications. Longer-term data regarding durability beyond 40 weeks will help inform use of the PDS.