Article Name: Archway Randomized Phase 3 Trial of the Port Delivery System With Ranibizumab for Neovascular Age-Related Macular Degeneration (Article in Press)
What is the clinical relevance?
The current standard for anti-VEGF therapy administration in patients with neovascular age-related macular degeneration (nAMD) is through monthly intravitreal injections. However, with advancing technology, the Port Delivery System (PDS) has tested the boundaries of future intravitreal therapeutic administration. The PDS is a permanent, implanted ocular drug delivery system that delivers a consistent drug concentration into the vitreous. The PDS reservoir is refillable through a self-sealing septum. The authors suggested that visual outcomes associated with anti-VEGF therapy would likely improve with the PDS as the current gap in effectiveness between clinical trials and clinical practice could be due to the barrier of consistent treatments. While the PDS would reduce overall treatment burden of nAMD, requiring therapeutic administration bi-annually, appropriate disease monitoring must ensure that nAMD progression does not go unnoticed.
What did this study demonstrate?
In Phase 3 of the ARCHWAY Clinical Trial, patients with an nAMD diagnosis and related neovascular lesions within 9 months of screening (n=415) were randomized into two treatment arms: surgical implantation of PDS receiving ranibizumab (100mg/ml) at 24-week refill intervals (n=248) or monthly intravitreal injections of ranibizumab (0.5 mg) (n=167). Primary outcome measures of the study were met as 98% of PDS-treated patients did not require supplemental ranibizumab prior to the 24-week refill interval and patients in this treatment arm demonstrated efficacy that mirrored that of the intravitreal injection arm (determined by best-corrected visual acuity score from baseline) at the 36-40 week end point. However, 19% of PDS-treated patients reported ocular adverse events compared to 6% in the intravitreal injection arm. Such adverse events included: endophthalmitis (1.6%), retinal detachment (0.8%), vitreous hemorrhages (5.2%), conjunctival erosions (2.4%), and conjunctival retractions (2.0%). Of the adverse events described above, 22 additional surgical interventions were required in 18 PDS-treated patients (7.3%). Majority of adverse outcomes occurred within the first month of PDS implantation suggesting that this procedure does not come without risk and needs to be further investigated to prioritize patient safety.
Reference:
Holekamp NM, Campochiaro PA, Chang MA, Miller D, Pieramici D, Adamis AP, et al. Archway Randomized Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology [Internet]. 2021 Sep 29 [cited 2021 Nov 15]; Available from: https://www.aaojournal.org/article/S0161-6420(21)00734-X/fulltext
Date Published: Sept 29, 2021
Summary By: Brooklyn Rawlyk