Aflibercept 8 mg Improves Vision in Treatment-Naive Diabetic Macular Edema: Study
Denmark: A real-world study from Denmark has found that first-line aflibercept 8 mg improved visual acuity and reduced retinal thickness in patients with treatment-naive diabetic macular edema. Over 300 days, patients experienced an average gain of 3.6 letters in visual acuity, with greater benefits observed in eyes with poorer baseline vision or more severe retinal swelling.
The study, published in Ophthalmology and Therapy, was conducted by Bjørg Debes, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark, and colleagues. The findings provide real-world evidence on the effectiveness of aflibercept 8 mg when used as the initial treatment for diabetic macular edema (DME).
DME is a leading cause of vision loss among working-age individuals with diabetes. It occurs when fluid accumulates in the macula, affecting central vision. Aflibercept, an anti-VEGF drug, helps reduce retinal fluid leakage. Although the 2 mg formulation is an established treatment, real-world evidence on the higher 8 mg dose remains limited.
To evaluate its effectiveness, researchers retrospectively analysed 95 eyes from 77 treatment-naive patients receiving first-line aflibercept 8 mg under an observe-and-plan regimen. Outcomes were assessed over 300 days, focusing on changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT), using statistical models to track changes over time.
The analysis revealed the following findings:
- Improved visual acuity: At 300 days, patients gained an average of 3.6 ETDRS letters in BCVA.
- Greater improvement in patients with poor baseline vision: Eyes with baseline BCVA of 60 ETDRS letters or lower gained 16.2 letters, equivalent to more than three lines on the vision chart.
- Significant reduction in retinal thickness: Mean CRT decreased by 84.9 µm over 300 days.
- Greater anatomical improvement in severe DME: Eyes with a baseline CRT of at least 400 µm showed a 170.1 µm reduction.
- Persistent macular edema: The estimated probability of center-involving macular edema was 70% at 90 days, 65% at 180 days, and 76% at 300 days, indicating the continued need for treatment.
- Short injection intervals: The median interval between completed injections at 300 days was 5.1 weeks. No adverse events were reported.
The researchers note that the visual and anatomical improvements were comparable to those reported in clinical trials, including across different levels of baseline vision and DME severity.
However, treatment decisions were physician-dependent, limiting the ability to distinguish treatment success from inadequate response. The observational design also precluded causal conclusions, while substantial follow-up attrition may have influenced the 300-day estimates.
The researchers concluded that first-line aflibercept 8 mg improved visual acuity and reduced retinal thickness in treatment-naive DME. However, persistent macular edema highlighted the need for sustained treatment and strategies to extend injection intervals without compromising outcomes.
Reference:
Debes, B., Kristensen, S.T., Dam-Dalgeir, G. et al. Real-World Longitudinal Outcomes of First-Line Aflibercept 8 mg for Treatment-Naïve Diabetic Macular Edema. Ophthalmol Ther (2026). https://doi.org/10.1007/s40123-026-01501-2
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