Real-World Functional and Anatomic Outcomes With Aflibercept 8.0 mg in Patients With Diabetic Macular Edema.

Abstract

Purpose: To assess clinical outcomes in diabetic macular edema (DME) patients treated with high-dose aflibercept 8.0 mg (HDA), focusing on treatment intervals, anatomic changes, and best-corrected visual acuity (BCVA). Methods: This retrospective, single-center study included 67 DME patients (100 eyes) treated at Cole Eye Institute between August 2023 and November 2024. All patients received at least 3 HDA injections, with a true loading dose defined as 3 initial injections given ≤ 5 weeks apart. The primary outcome was proportion of eyes for which minimum ≥ 7-week treatment intervals were maintained. Secondary outcomes included changes in BCVA, central subfield thickness (CST), and macular fluid status. Results: Loading dose was completed in 73 eyes (73%) and not completed in 27 eyes (27%). Before HDA injections, 4.0% of eyes were anti-vascular endothelial growth factor naive. Mean (±SD) follow-up was 24.3 ± 5.0 weeks. From baseline to final visit, mean (±SD) CST significantly decreased (from 371.1 ± 134.6 μm to 330.0 ± 121.7 μm; P = .025), while BCVA remained stable (from 62.4 ± 18.8 to 63.5 ± 17.7 ETDRS letters; P = .676). For 32 eyes (32%), ≥ 7-week treatment intervals could not be maintained, with 18 eyes being switched to alternative therapy and 14 eyes requiring < 7-week injection intervals; these eyes had significantly higher baseline CST (P = .045). Persistent macular fluid was observed in 90% of eyes. Conclusion: HDA reduced CST and stabilized BCVA in DME patients. However, remaining challenges include frequent injections and persistent macular fluid, underscoring the chronic, treatment-resistant nature of DME and need for optimized treatment strategies.