Functional Real-World Outcomes of Aflibercept 8 mg Versus Faricimab After Loading Phase in Diabetic Macular Edema
摘要
Aflibercept 8 mg and faricimab provide effective anatomical and visual acuity improvements in diabetic macular edema (DME), although functional recovery may not be fully captured by conventional endpoints. Microperimetry offers a sensitive and spatially resolved assessment of macular function and may better reflect early neurosensory changes.
MethodsThis real-world, retrospective comparative cohort study included 60 treatment-naïve eyes of 60 patients with center-involving DME treated at Ospedale Fiorini di Terracina. Thirty eyes received intravitreal aflibercept 8 mg and 30 eyes received intravitreal faricimab 6 mg as three consecutive monthly injections. Outcomes included best-corrected visual acuity (BCVA), central retinal thickness (CRT) measured by spectral-domain optical coherence tomography, and mean retinal sensitivity (RS) assessed using Nidek MP-3 microperimetry. Statistical analyses included paired and unpaired t tests, repeated-measures analysis of variance, odds ratios (OR) for achieving a ≥ 3 dB RS gain, and Pearson correlation analyses.
ResultsBoth treatments significantly improved BCVA and CRT after the loading phase, with slightly greater improvements observed in the faricimab group, although not statistically significant. Mean CRT reduction was − 122 ± 47 µm with aflibercept 8 mg and − 138 ± 52 µm with faricimab (p = 0.21). BCVA improved by + 5.8 ± 4.9 and + 7.2 ± 5.4 letters, respectively (p = 0.17). Retinal sensitivity increased in both groups, with a greater gain observed with faricimab (+ 4.8 ± 1.9 dB) compared with aflibercept (+ 2.1 ± 1.6 dB; p < 0.001). Faricimab-treated eyes were more likely to achieve a ≥ 3 dB RS improvement (OR 3.2; 95% CI 1.4–7.6). RS improvement correlated with CRT reduction (r = 0.42) and BCVA gain (r = 0.57).
ConclusionDespite similar anatomical and visual acuity outcomes, faricimab was associated with greater short-term improvement in retinal sensitivity compared with aflibercept 8 mg during the loading phase. These findings support microperimetry as a sensitive functional endpoint in DME research and selected clinical settings.