ArticleOphthalmology science2026
Hard Exudates in Diabetic Macular Edema: Automated OCT Quantification and Longitudinal Response to Faricimab.
Article in Ophthalmology science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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10 authors.
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Abstract
Purpose: To develop and validate an automated OCT-based pipeline for hard exudates (HEs) quantification and to characterize their longitudinal evolution in eyes with diabetic macular edema (DME) treated with faricimab. Design: Retrospective, single-center observational study. Subjects: Treatment-naïve and previously treated DME eyes initiating intravitreal faricimab with ≥2 visits and a minimum follow-up of 3 months. Methods: All patients underwent best-recorded visual acuity (VA) assessment and serial OCT imaging (Spectralis HRA system, Heidelberg Engineering). A custom ImageJ-based pipeline was used to quantify HE across volumetric datasets. Extracted metrics included total lesion count, square-root-transformed area, lesion density, and spatial distribution. Faricimab was administered using a treat-and-extend regimen following a 3-monthly injection loading phase. Main Outcome Measures: Agreement with manual grading assessed using intraclass correlation coefficients and Bland-Altman analysis; longitudinal changes in VA, central subfield thickness (CST), and HE metrics modeled using linear mixed-effects models with evaluation of nonlinear trajectories via natural cubic splines and interaction effects with clinical and treatment-related predictors. Results: Eighty-three eyes from 65 patients (mean age 64 ± 10 years) were included, of which 72 (87%) presented with HE at baseline. Automated quantification showed good to excellent agreement with manual grading (intraclass correlation coefficient 0.85-0.92). Greater baseline HE area was associated with treatment-naïve status (β = 56.5, Conclusions: Automated OCT-based quantification enables reproducible assessment of HE burden and its longitudinal dynamics in DME. Faricimab treatment was associated with a significant, nonlinear reduction in HE, accompanied by improvements in CST and VA over follow-up. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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