Functional and structural efficacy of a novel combinational therapy of aflibercept and timely focal/grid photocoagulation in diabetic macular oedema: do clinical study results compare favourably with a standard-of-care treated real-world population?

Purpose: To evaluate treatment efficacy in diabetic macular oedema (DME) comparing a study population receiving combined intravitreal vascular endothelial growth factor (VEGF) inhibition and focal/grid photocoagulation with a matched, real-world population receiving standard of care treatment. Methods: In an exploratory study, we included 43 eyes from 32 patients from a previously published study as well as 46 eyes from 38 standard-of-care patients. The study population had received a loading dose of three monthly aflibercept injections followed by focal/grid photocoagulation and additional aflibercept pro re nata. Principal measurements at 12 months were numbers of intravitreal injections, best corrected visual acuity (BCVA) and central retinal thickness (CRT). Results: At baseline, there were no differences between groups regarding age, sex, body mass index, haemoglobin A₁C, systolic pressure or type of diabetes, but the study population had a higher diastolic pressure (81.6 versus 72.1 mmHg, p = 0.03) and a lower duration of diabetes (12.3 versus 23.2 years, p = 0.03). At month 12, patients in the study group had a higher visual acuity (79.6 versus 74.3 ETDRS letters, p = 0.03), despite having received fewer aflibercept injections (4.4 versus 5.9, p < 0.01) with a higher likelihood of having only received the three mandatory injections in the loading phase (39.5% versus 13.0%, p = 0.01). Conclusion: In comparison to a matched, real-world DME-population, patients in combined treatment with intravitreal aflibercept and postloading focal/grid photocoagulation obtained a better functional outcome despite having received fewer intravitreal injections. Future randomized studies are needed to evaluate the long-term efficacy of this combined treatment regimen.