Abstract
We evaluated the real-world efficacy of intravitreal faricimab for diabetic macular edema (DME) and its relationship with visual and retinal anatomical changes using optical coherence tomography. We retrospectively assessed 174 patients (214 eyes) with DME from 13 Japan Clinical REtina Study Group (J-CREST) sites who received ≥ 1 faricimab injection and were followed ≥ 6 months, and compared treatment-naïve (with no prior anti-VEGF treatment) and previously treated groups. Both groups showed significant improvements in best-corrected visual acuity (BCVA) and central subfield thickness (CST BCVA gain was greater in the treatment-naïve group (p = 0.0109), whereas CST reduction showed little difference (p = 0.31). Resolution of cystoid macular oedema, diffuse retinal thickening, and subretinal fluid (SRF) was observed in both groups. Resolution of inner nuclear layer (INL) oedema and SRF significantly correlated with ≥ 0.2 log MAR BCVA improvement in the treatment-naïve group (p = 0.043 and p = 0.022, respectively). Mean number of injections was comparable between groups. One case of anterior chamber inflammation occurred; however, no serious systemic events were observed. In conclusion, faricimab significantly improved visual and anatomical outcomes in DME, especially in treatment-naïve eyes. Early resolution of INL oedema and SRF may serve as a potential biomarker for visual prognosis.