Author: Arshad Khanani (United States)
Co-authors: Steven Blotner, Shamika Gune, Merce Morral
Purpose
The Port Delivery System with ranibizumab (PDS) is an investigational drug delivery system for the continuous delivery of ranibizumab into the vitreous, which was evaluated for the treatment of neovascular age-related macular degeneration (nAMD) in the Archway phase 3 trial. This analysis aims to determine the incidence of subretinal fluid (SRF) and/or intraretinal fluid (IRF) from baseline to week 40 in Archway and assess vision outcomes based on presence, type, and location of fluid.
Setting/Venue
Archway (NCT03677934) was a randomized, multicenter, open-label (visual assessor–masked), active treatment–controlled study in patients with nAMD.
Methods
Patients were randomized 3:2 to the PDS with ranibizumab 100 mg/mL with fixed 24-week refill-exchanges (PDS Q24W) or intravitreal ranibizumab 0.5 mg every 4 weeks (monthly ranibizumab). This post hoc analysis comprised patients from Archway with data on the presence/absence of SRF/IRF at baseline. The presence of retinal fluid was assessed using optical coherence tomography at each monthly visit, independently graded for SRF or IRF. Analysis outcomes included the proportion of patients with either SRF or IRF (and SRF and/or IRF in the center 1 mm [SRF/IRF 1 mm]) and change in best-corrected visual acuity (BCVA) from baseline (Early Treatment Diabetic Retinopathy Study [ETDRS] letters) in study eyes in the presence or absence of SRF/IRF up to week 40.
Results
Percentage of patients with either SRF or IRF was similar between the PDS Q24W and monthly ranibizumab treatment arms at baseline (47.6% [118/248] vs 50.9% [85/167]) and week 40 (50.6% [120/237] vs 48.4% [77/159]). Vision outcomes were comparable between treatment arms, regardless of presence/absence of any retinal fluid, including presence/absence of SRF in the center 1 mm (SRF 1 mm); mean (95% CI) BCVA change (ETDRS letters) from baseline at week 40 with PDS Q24W versus monthly ranibizumab: absence of SRF 1 mm, +0.9 (–0.1, 1.9; n = 182) versus +0.6 (–0.6, 1.8; n = 137); presence of SRF 1 mm, +0.2 (–1.6, 2.0; n = 51) versus +1.0 (–1.7, 3.8; n = 21). BCVA vision outcomes were also comparable between the PDS Q24W and monthly ranibizumab arms in the absence of IRF in the center 1 mm (IRF 1 mm): +0.8 (–0.1, 1.7; n = 216) versus +1.0 (–0.0, 2.0; n = 147), but appeared to be slightly reduced in the monthly ranibizumab arm in the presence of IRF 1 mm: PDS Q24W, +0.1 (–3.6, 3.8; n = 17); monthly ranibizumab, –3.5 (–11.8, 4.7; n = 11).
Conlusions
In Archway, the incidence of retinal fluid was generally similar in the PDS Q24W and monthly ranibizumab treatment arms and remained consistent over time. Vision outcomes were generally comparable in both treatment arms. Continuous delivery of ranibizumab with PDS Q24W maintained vision outcomes, regardless of the presence or absence of retinal fluid.
Financial Disclosure
Consultant, honoraria: Adverum, Aerpio, Alcon, Allergan, Dutch Ophthalmic Research Center, Genentech, Inc., Kato Pharmaceuticals, Kodiak Sciences Inc., Novartis, Gemini Therapeutics, Graybug, Gyroscope, Opthea, Oxurion, PolyPhotonix, Recens Medical, Regenxbio; Research support: Adverum, Alkahest, Allergan, Allegro, Gemini Therapeutics, Genentech, Inc., Gyroscope, Iveric Bio, NGM pharmaceuticals, Kodiak Sciences Inc., Novartis, Opthea, Ophthotech, Oxurion, Regenxbio; Recens Medical; Speaker: Allergan, Genentech and Novartis.
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