For a study, researchers sought to assess the safety and effectiveness of the Port Delivery System with ranibizumab (PDS) in the treatment of neovascular age-related macular degeneration (nAMD). Patients with nAMD detected within 9 months after screening who had previously received and responded to anti-vascular endothelial growth factor treatment PDS with ranibizumab 100 mg/ml with fixed 24-week (Q24W) refill-exchanges (PDS Q24W) or intravitreal ranibizumab 0.5-mg injections every 4 weeks were given to patients in a 3:2 split (monthly ranibizumab).
Archway included 418 patients: 251 were randomized to and 248 were treated with the PDS Q24W, while 167 were randomized to and treated with monthly ranibizumab. The baseline BCVA was 74.4 letters for the PDS Q24W arm and 75.5 letters for the monthly ranibizumab arm (Snellen equivalent, 20/32). The adjusted mean change in BCVA score from baseline in the PDS Q24W arm was +0.2 letters (standard error [SE], 0.5 letters) and +0.5 letters (SE, 0.6 letters) in the monthly ranibizumab arm (difference, –0.3 letters; 95% CI, –1.7 to 1.1 letters). PDS Q24W was not worse nor superior to monthly ranibizumab. Of the 246 PDS-treated patients evaluated for supplementary ranibizumab medication, 242 (98.4%) did not get it before the first refill-exchange procedure, including four patients who quit treatment before the first refill-exchange process. Prespecified ocular adverse events of special interest were reported in 47 patients (19.0%) in the PDS Q24W arm and 10 patients (6.0%) in the monthly ranibizumab arm, including 4 (1.6%) endophthalmitis cases, 2 (0.8%) retinal detachments, 13 (5.2%) vitreous hemorrhages, 6 (2.4%) conjunctival erosions, and 5 (2.0%) conjunctival retractions in the former arm. The majority of ocular adverse events occurred within one month of implantation in the PDS Q24W arm. Archway achieved its primary goal, with PDS Q24W demonstrating non-inferior and equal effectiveness to monthly ranibizumab, with 98.4% of PDS-treated patients not having supplementary medication in the first 24-week period.
Reference:www.aaojournal.org/article/S0161-6420(21)00734-X/fulltext
