Post hoc analysis of ARIES study clarifies fluid-related criteria for treat-and-extend
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A post hoc analysis of the ARIES study showed a correlation between presence of intraretinal fluid and poorer vision, while a stable, limited amount of subretinal fluid may be beneficial.
“These findings suggest that the use of combined SRF and IRF as a surrogate marker for BCVA and its use to guide treatment extension decisions alone should be reconsidered,” Paul Mitchell, MD, said at the virtual Euretina congress.
ARIES was a multicenter, randomized, open-label phase 3b/4 study evaluating the efficacy of aflibercept treat-and-extend regimen in patients with neovascular age-related macular degeneration.
“Since increasing evidence suggests that presence or absence of fluid in different retinal compartments may play an important role in the functional outcomes of patients treated with anti-VEGFs, our post hoc analysis explored the relationship between retinal fluid compartments status and BCVA in order to guide treatment extension decisions,” Mitchell said.
The ARIES study protocol established that the treatment interval would be extended if there was an absence of intraretinal fluid (IRF) and subretinal fluid (SRF) that was equal to or less than 50 µm. Conversely, it would be shortened if there was any IRF or SRF greater than 50 µm. Minimum interval was 8 weeks, and maximum was 16 weeks. The relationship between presence of fluid and best corrected visual acuity was assessed at all mandatory visits.
“A complete absence of both IRF and SRF was not associated with better visual function at any time point,” Mitchell said. “Looking at the absence of SRF and IRF separately, the absence of SRF at any time point was associated with poorer visual function than if SRF was present. On the other hand, the presence of IRF at most time points was associated with poorer visual function than if IRF was absent.”
Consequently, absence of any fluid should not be considered as a positive sign that allows the extension of the treatment interval, but the fluid compartment is what should be looked at.
“Elimination of IRF should be the focus of proactive treatment regimens. SRF that is stable after appropriate treatment initiation does not negatively impact on patient outcomes and should be tolerated,” Mitchell said.
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Mitchell P, et al. Retinal fluid compartment status and functional outcomes in patients with neovascular age-related macular degeneration treated with intravitreal aflibercept using a treat-and-extend regimen: a post-hoc analysis of the ARIES study. Presented at: Euretina congress; Oct. 2-4, 2020 (virtual meeting).
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