Association between visual acuity and intraretinal (IRF) or subretinal (SRF) fluid in patients with neovascular age-related macular degeneration (nAMD) treated with intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E): a post-hoc analysis of the ARIES study

Abstract

Purpose : To explore the relationship between IRF/SRF and best-corrected visual acuity (BCVA) in patients with nAMD treated with IVT-AFL to guide treatment extension decisions.

Methods : ARIES (NCT02581891) was a multicenter, randomized, Phase 3b/4 study that compared the efficacy of 2 different IVT-AFL T&E dosing regimens over 2 years in treatment-naïve patients with nAMD. This post-hoc analysis explored the relationship between presence of fluid (SRF and IRF) and BCVA by describing absolute BCVA by fluid subgroups at baseline (BL) and by fluid status at fixed visits (Weeks [w] 4, 8, 16, 52, and 104).

Results : The per-protocol set comprised 210 patients (two treatment arms combined). Absence of SRF at BL was associated with lower BCVA (5–10 less letters) than if SRF was present; furthermore, at every timepoint, the absence of SRF was associated with poorer BCVA (letters) than if SRF was present (no SRF vs SRF: 64.5 vs 67.2 [w4]; 66.3 vs 68.5 [w8]; 66.4 vs 70.7 [w16]; 68.3 vs 73.6 [w52]; 65.4 vs 72.9 [w104]). Presence of IRF at BL was associated with lower BCVA (7–9 less letters) than if IRF was absent; furthermore, at most timepoints, presence of IRF was associated with poorer BCVA (letters) than if IRF was absent (IRF vs no IRF: 61.2 vs 65.9 [w4]; 66.6 vs 66.8 [w8]; 59.0 vs 69.3 [w16]; 66.2 vs 70.0 [w52]; 70.1 vs 67.4 [w104]). The presence of both SRF+IRF at BL was associated with lower BCVA (6–8 less letters) than if only SRF was present but was associated with a higher BCVA (3–9 more letters) than if only IRF was present. Absence of SRF+IRF was not associated with better BCVA (letters) at any timepoint (no fluid vs fluid: 64.7 vs 66.8 [w4]; 66.5 vs 67.7 [w8]; 67.3 vs 69.2 [w16]; 68.5 vs 72.6 [w52]; 65.3 vs 71.9 [w104]).

Conclusions : In ARIES, IVT-AFL T&E was effective at reducing fluid and improving vision in treatment-naïve nAMD eyes regardless of fluid type. Post-hoc analyses showed that good functional outcomes were achieved in the presence of SRF, whereas IRF was consistently associated with poorer functional outcomes. These findings indicate the need to differentiate SRF and IRF as surrogate markers for BCVA, in order to guide treatment extension decisions.

This is a 2021 ARVO Annual Meeting abstract.