Introduction: 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. Methods: This 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. Results: Both 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). Conclusion: Despite 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.

Functional Real-World Outcomes of Aflibercept 8 mg Versus Faricimab After Loading Phase in Diabetic Macular Edema / Menna, F., Calabro, M., Guillot, A., De Luca, L., Meduri, A., Baldascino, A., Lupo, S., Vingolo, E.M.. - In: OPHTHALMOLOGY AND THERAPY. - ISSN 2193-8245. - 15:7(2026), pp. 2245-2254. [10.1007/s40123-026-01395-0]

Functional Real-World Outcomes of Aflibercept 8 mg Versus Faricimab After Loading Phase in Diabetic Macular Edema

Menna, Feliciana
Methodology
;
Calabro, Mattia
Writing – Original Draft Preparation
;
Guillot, Antonio
Data Curation
;
Lupo, Stefano
Writing – Original Draft Preparation
;
Vingolo, Enzo Maria
Supervision
2026

Abstract

Introduction: 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. Methods: This 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. Results: Both 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). Conclusion: Despite 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.
2026
Aflibercept 8 mg; Anti-VEGF; Diabetic macular edema; Diabetic retinopathy; Faricimab; Microperimetry; Retinal sensitivity
01 Pubblicazione su rivista::01a Articolo in rivista
Functional Real-World Outcomes of Aflibercept 8 mg Versus Faricimab After Loading Phase in Diabetic Macular Edema / Menna, F., Calabro, M., Guillot, A., De Luca, L., Meduri, A., Baldascino, A., Lupo, S., Vingolo, E.M.. - In: OPHTHALMOLOGY AND THERAPY. - ISSN 2193-8245. - 15:7(2026), pp. 2245-2254. [10.1007/s40123-026-01395-0]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1779232
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