One-year anti-VEGF therapy outcomes in diabetic macular edema based on treatment intensity: Data from the FRB! registry

Purpose: To compare one-year outcomes of eyes with diabetic macular edema (DME) treated in routine clinical practice based on the proportion of visits where intravitreal vascular endothelial growth factor (VEGF) inhibitor injections were delivered.

Design: Cohort study PARTICIPANTS: There were 2288 treatment-naïve eyes with DME starting intravitreal VEGF inhibitor therapy from 31 October 2015 to 31 October 2021 from the Fight Retinal Blindness! international outcomes registry.

Methods: Eyes were grouped according to the proportion of visits at which an injection was received, Group A with less than the median of 67% (n=1172) versus Group B with greater than the median (n=1116).

Main outcome measure: Mean visual acuity (VA) change after 12 months of treatment.

Results: The mean (95% confidence interval [CI]) VA change after 12 months of treatment was 3.6 (2.8, 4.4) letters for eyes in Group A versus 5.2 (4.4, 5.9) letters for eyes in Group B (p=0.005). The mean (95% CI) central subfield thickness (CST) change was -69 (-76, -61) μm and -85 (-92, -78) μm for eyes in Group A versus Group B, respectively (p=0.002). A moderate positive correlation was observed between the number of injections received over 12 months of treatment and the change in VA (p<0.001). Additionally, eyes that received more injections had a moderately greater CST reduction. Conclusions: This registry analysis found that overall VA and anatomic outcomes tended to be better in DME eyes treated at a greater proportion of visits in the first year of intravitreal VEGF inhibitor therapy. Keywords: Diabetic macular edema; Pro-Re-Nata; VEGF inhibitor; anti-VEGF; fixed; proactive; reactive regimen; real-world evidence; registry; treat-and-extend; treatment pattern.