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  • Is complete fluid resolution necessary in patients with choroidal neovascularization secondary to AMD?

    Retina/Vitreous

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    Investigators compared visual acuity in patients with neovascular AMD tolerating some subretinal fluid (SRF) with those undergoing treatment to resolve all SRF.

    Study design

    The authors conducted a multicenter, randomized, 24-month, phase 4, single-masked, noninferiority clinical trial (FLUID study). They recruited 349 patients with treatment-naïve, active subfoveal choroidal neovascularization due to AMD. Participants were randomized to receive 0.5 mg monthly ranibizumab until either complete resolution of both intraretinal and subretinal fluid (intensive treatment; n=174) or until complete intraretinal fluid resolution with up to 200 μm of foveal SRF remaining (relaxed treatment; n=175). The primary outcomes were number of ranibizumab injections, and mean change in BCVA and central subfield thickness (CST) at 24 months.

    Outcomes

    Change in BCVA in the relaxed treatment group was similar and noninferior to the intensive treatment group (2.6 vs 3 letters). A similar proportion of subjects in both cohorts gained 15 or more letters at 12 and 24 months.

    The relaxed group received fewer injections than the intensive group over the 24-month study (15.8 vs. 17; P=0.001). The intensive arm, however, showed a greater reduction in CST than the relaxed group (153 μm vs 127 μm; P=0.06). The number of adverse events in both groups were comparable.

    Limitations

    Limitations of this study include the absence of a masked investigator, though both subjects and BCVA assessors were masked. There were baseline differences in choroidal neovascularization sizes between the 2 treatment arms. Letter gains in both groups were not similar to the levels achieved in previous trials. Although the study lasted 24 months, this may not have been enough time to understand the long-term effects of untreated SRF.

    Clinical significance

    In patients with neovascular AMD, tolerating some SRF (≤200 μm in the foveal center) can achieve similar visual acuity outcomes at 24 months as aiming for complete resolution of SRF using a ranibizumab treat-and-extend regimen.