Early Intraretinal Fluid Reduction is Linked to Vision Gains in Patients with Diabetic Macular Edema

Abstract

This analysis evaluated the impact of early intraretinal fluid (IRF) reduction on long-term visual outcomes in patients with diabetic macular edema (DME). This was a treatment-agnostic, post hoc analysis of pooled data from patients with DME in YOSEMITE/RHINE (NCT03622580/NCT03622593). The relationship between IRF volume changes (evaluated using deep learning-based retinal optical coherence tomography segmentation algorithm [ROSA]) after 3-monthly injections and anatomical/visual outcomes at 2 years was assessed. Patients were categorized by proportional IRF volume reduction from baseline at month 3: < 20% (group 1), 20–50% (group 2), > 50% (group 3). Comparisons were made across groups, including changes from baseline in ROSA-derived fluid volume and best-corrected visual acuity (BCVA). A complementary analysis was performed based on IRF volume reduction at 1-month and 1-year outcomes. The main analysis included eyes from 795 patients: 259 (32.6%) treated with faricimab 6 mg every 8 weeks (Q8W), 279 (35.1%) treated with faricimab 6 mg treat-and-extend, and 257 (32.3%) treated with aflibercept 2 mg Q8W. In groups 1–3, mean IRF volume decreases from baseline at year 2 were 236, 282, and 312 nL (nominal p < 0.05 for groups 2 and 3 vs. 1), respectively. Corresponding subretinal fluid volume decreases were 37, 48, and 41 nL, respectively. In groups 1–3, adjusted mean BCVA increases from baseline at year 2 were 7.9, 10.3, and 12.2 letters (nominal p = 0.0005 for group 1 vs. 3), respectively, with 23%, 36%, and 41% of patients (nominal p = 0.0015 for group 1 vs. 3), respectively, gaining ≥ 15 letters. Similar results were observed in the complementary analysis. Greater IRF volume reduction during the first 3 months of treatment was associated with improved long-term outcomes in DME. These data may inform discussions between physicians and their patients when discussing long-term anatomic/functional outcomes of treatment. ClinicalTrials.gov identifier: NCT03622580/NCT03622593 (YOSEMITE/RHINE).