%0 Journal Article
%T Supplemental Intravitreal Ranibizumab Injections in Eyes Treated with the Port Delivery System with Ranibizumab in the Archway Trial.
%A Nielsen JS
%A Chang A
%A Holekamp NM
%A Cavichini-Cordeiro M
%A Lin SL
%A Heinrich D
%A Maass KF
%A Menezes A
%A Singh N
%A Pieramici DJ
%J Ophthalmol Retina
%V 0
%N 0
%D 2024 Jun 22
%M 38914294
暂无%R 10.1016/j.oret.2024.06.012
%X <B>OBJECTIVE: </B>To determine the proportion and characteristics of eyes with neovascular age-related macular degeneration (nAMD) treated with the Port Delivery System (PDS) with ranibizumab that receive supplemental intravitreal ranibizumab injections because of changes in best-corrected visual acuity (BCVA) or central subfield thickness (CST), or both, and to investigate the safety and efficacy of supplemental injections in eyes with the PDS.<BR><B>METHODS: </B>Post hoc analyses of data from the phase III, randomized, multicenter, open-label, active-comparator Archway trial (NCT03677934).<BR><B>METHODS: </B>Adults with nAMD diagnosed within 9 months of screening previously responsive to anti-VEGF therapy.<BR><B>METHODS: </B>Four hundred eighteen patients were randomized to the PDS with ranibizumab 100 mg/ml with fixed refill-exchanges every 24 weeks (Q24W) or monthly intravitreal ranibizumab 0.5 mg for 96 weeks.<BR><B>RESULTS: </B>Of the 246 eyes treated with the PDS Q24W and assessed for supplemental treatment criteria, the vast majority (94.6%-98.4%) did not receive supplemental treatment during each retreatment interval, with 87.4% not receiving supplemental treatment at any point during the trial. Of the 31 eyes receiving supplemental treatment, 58.1% received 1 injection and 32.3% received 2. At baseline, eyes receiving supplemental treatment were significantly more likely to have thicker retinas (mean CST, 370.5μm vs. 304.4μm; P = 0.0001), subretinal fluid (54.8% vs. 21.2%; P < 0.0001), and larger pigment epithelial detachment height (215.7 μm vs. 175.9 μm; P = 0.003). These features have previously been associated with difficult-to-treat nAMD. Although BCVA and CST generally remained constant throughout the trial in eyes without supplemental treatment, the small number of eyes receiving supplemental treatment on average lost 1 line of vision from baseline to week 96 (mean, -5.7 ETDRS score letters) and CST continued to increase over time. Absolute BCVA at week 96 was similar irrespective of supplemental treatment status (71.1 and 73.7 letters). Best-corrected visual acuity and CST generally improved within 28 days of supplemental treatment.<BR><B>CONCLUSIONS: </B>Although the PDS Q24W effectively maintains vision and retinal stability in most eyes with nAMD, a small proportion of patients with features of difficult-to-treat nAMD may benefit from supplemental intravitreal anti-VEGF injections and initial close monitoring is recommended.<BR><B>BACKGROUND: </B>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.