OCT outcomes as biomarkers for disease status, visual function, and prognosis in diabetic macular edema

To evaluate disorganization of retinal inner layers (DRIL), as detected on spectral-domain optical coherence tomography (OCT) images, as a biomarker for diabetic macular edema (DME) activity, visual function, and prognosis in eyes with DME. Longitudinal prospective. Post hoc correlation analyses were performed on data from a phase 2 clinical trial. Seventy-one eyes of 71 patients with treatment-naive DME received either suprachoroidally administered CLS-TA (proprietary formulation of a triamcinolone acetonide injectable suspension) combined with intravitreal aflibercept or intravitreal aflibercept with a sham suprachoroidal injection procedure. DRIL area, maximum horizontal extent of DRIL, ellipsoid zone (EZ) integrity, and the presence and location of subretinal (SRF) and intraretinal fluid (IRF) were evaluated at baseline and week 24 by certified reading centre graders. At baseline, the area and maximum horizontal extent of DRIL were negatively correlated with best-corrected visual acuity (BCVA; r = –0.25, p = 0.05 and r = –0.32, p =0.01, respectively). Mean baseline BCVA progressively worsened with each ordinal drop in EZ integrity, improved with the presence of SRF, and was invariant to the presence of IRF. DRIL area and maximum extent were significantly decreased at week 24 (–3.0 mm2 [p < 0.001] and –775.8 mm [p < 0.001], respectively. At week 24, decreases in the area and maximum horizontal extent of DRIL were positively correlated with increases in BCVA (r = –0.40, p = 0.003 and r = –0.30, p = 0.04). Improvements in BCVA at week 24 were no different between patients showing improvement in EZ, SRF, or IRF and those showing no improvement or worsening from baseline. DRIL area and DRIL maximum horizontal extent were demonstrated to be novel biomarkers for macular edema status, visual function, and prognosis in eyes with treatment-naive DME. Évaluer la désorganisation des couches rétiniennes internes (DRIL) sur les images obtenues à la tomographie par cohérence optique (OCT) en domaine spectral à titre de biomarqueur de l'activité de l’œdème maculaire diabétique (OMD), de la fonction visuelle et du pronostic dans des yeux présentant un OMD. Étude longitudinale prospective. Des analyses de corrélation a posteriori ont été réalisées sur des données issues d'une étude clinique de phase 2 au cours de laquelle 71 yeux de 71 patients présentant un OMD jamais traité ont été répartis en 2 groupes de traitement : administration suprachoroïdienne de CLS-TA (prépa