Ophthalmology and therapy · 2026
Real-World Longitudinal Outcomes of First-Line Aflibercept 8 mg for Treatment-Naïve Diabetic Macular Edema.
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Debes Bjørg, Kristensen Sarah Tovsgård, Dam-Dalgeir Gertrud, Lee Celine, Mæng Mads Odgaard, Petersen Line, Vorum Henrik, Subhi Yousif, Trivizki Omer, Ørskov Marie, Cehofski Lasse Jørgensen
Аннотация
INTRODUCTION: We sought to evaluate longitudinal visual and anatomical outcomes in treatment-naïve eyes with diabetic macular edema (DME) treated with aflibercept 8 mg in routine clinical practice.
METHODS: Treatment-naïve eyes with DME receiving aflibercept 8 mg as first-line therapy under an observe-and-plan regimen were evaluated. Medical records were retrospectively reviewed, collecting data on best-corrected visual acuity (BCVA), central retinal thickness (CRT), and follow-up visits. Longitudinal changes in BCVA and CRT were analyzed using linear mixed-effects models with random effects to account for repeated measurements. Analyses were restricted to the first 300 days after baseline.
RESULTS: A total of 95 eyes from 77 patients were eligible for evaluation. In the linear mixed-effect model, the estimated marginal mean BCVA improved by 3.6 ETDRS letters (95% CI 1.7-5.6) at 300 days, with eyes with a baseline BCVA ≤ 60 ETDRS achieving a 16.2 ETDRS letter gain (95% CI 12.2-20.1). In the mixed-effect model, the mean CRT decreased by 84.9 µm (95% CI - 103.1 to - 66.6) at 300 days while a CRT decline of 170.1 µm (95% CI -199.2 to -141.1) was achieved in severe DME (baseline CRT ≥ 400 µm). The estimated marginal probability of center-involving macular edema was 0.70 (95% CI 0.55-0.82) at 90 days, 0.65 (95% CI 0.51-0.77) at 180 days, and 0.76 (CI 95% 0.62-0.86) at 300 days. The median last completed injection interval at 300 days was 5.1 weeks (IQR 4.1-6.3 weeks). No adverse event was reported.
CONCLUSIONS: Aflibercept 8 mg resulted in a meaningful improvement in BCVA and significant reduction in CRT. The estimated marginal probability of center-involving macular edema suggests that sustained therapy is required during the first 300 days of treatment. The study highlights the need for the development of real-world strategies to reach long injection intervals.
METHODS: Treatment-naïve eyes with DME receiving aflibercept 8 mg as first-line therapy under an observe-and-plan regimen were evaluated. Medical records were retrospectively reviewed, collecting data on best-corrected visual acuity (BCVA), central retinal thickness (CRT), and follow-up visits. Longitudinal changes in BCVA and CRT were analyzed using linear mixed-effects models with random effects to account for repeated measurements. Analyses were restricted to the first 300 days after baseline.
RESULTS: A total of 95 eyes from 77 patients were eligible for evaluation. In the linear mixed-effect model, the estimated marginal mean BCVA improved by 3.6 ETDRS letters (95% CI 1.7-5.6) at 300 days, with eyes with a baseline BCVA ≤ 60 ETDRS achieving a 16.2 ETDRS letter gain (95% CI 12.2-20.1). In the mixed-effect model, the mean CRT decreased by 84.9 µm (95% CI - 103.1 to - 66.6) at 300 days while a CRT decline of 170.1 µm (95% CI -199.2 to -141.1) was achieved in severe DME (baseline CRT ≥ 400 µm). The estimated marginal probability of center-involving macular edema was 0.70 (95% CI 0.55-0.82) at 90 days, 0.65 (95% CI 0.51-0.77) at 180 days, and 0.76 (CI 95% 0.62-0.86) at 300 days. The median last completed injection interval at 300 days was 5.1 weeks (IQR 4.1-6.3 weeks). No adverse event was reported.
CONCLUSIONS: Aflibercept 8 mg resulted in a meaningful improvement in BCVA and significant reduction in CRT. The estimated marginal probability of center-involving macular edema suggests that sustained therapy is required during the first 300 days of treatment. The study highlights the need for the development of real-world strategies to reach long injection intervals.