One-Year Results of Using a Treat-and-Extend Regimen without a Loading Phase with Anti-VEGF Agents in Patients with Treatment-Naive Diabetic Macular Edema

Purpose: To evaluate real-life outcomes in treatment-naive patients with diabetic macular edema (DME) treated with anti-vascular endothelial growth factor (VEGF) agents using a treat-and-extend regimen without a fixed loading phase. Methods: Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) measured using optical coherence tomography at baseline and after 1 year of treatment, intervals and number of injections were analyzed. Subgroup analysis was performed to compare anatomical and functional outcomes between patients receiving ranibizumab or aflibercept. Results: Seventy-five eyes of 61 patients met the inclusion criteria and had follow-up for 1 year. Baseline BCVA and CRT were 68.1 +/- 13.2 letters and 424 +/- 135 mu m, retrospectively. After 1 year, there was a significant mean gain in BCVA of + 5.8 +/- 7.4 letters (paired t test: p < 0.0001) and a significant decrease in mean CRT of -117 +/- 134 mu m (paired t test: p < 0.0001). The mean number of anti-VEGF injections was 10.0 +/- 1.6 (range 6-12). The mean maximum interval between injections was 8.5 +/- 2.9 weeks (range 4-14) and the mean interval 6.0 +/- 1.2 weeks (range 4.1-8.9). 96% of eyes could be extended after a mean of 5.3 injections and 17% of patients could be extended before reaching a formal loading dose of 3 injections. Subgroup analysis did not reveal any differences in outcomes between patients treated with ranibizumab or aflibercept. Subretinal fluid at baseline was associated with better BCVA gain after 1 year (stepwise forward regression analysis, p = 0.003). Conclusion: Our results suggest that not all patients with DME require a fixed loading phase when initiating anti-VEGF treatment. Finding anatomical predictors to identify this subgroup of patients would help to reduce treatment burden and optimize clinical outcomes. (C) 2019 S. Karger AG, Basel