Optical coherence tomography angiography in diabetic macular edema treated with intravitreal aflibercept: a 48-week observational study (the DOCTA study)

Introduction: Central vision loss due to diabetic macular edema (DME) is related to the macular edema itself, but also in some cases to alterations of the foveal avascular zone (FAZ). The aim of this trial was to study changes in macular vessels in eyes with DME treated with aflibercept using optical coherence tomography angiography (OCTA).Methods: This was a longitudinal, prospective, non-controlled, single arm study. The primary objective was the quantitative assessment of macular vessels over time in patients with DME treated with intravitreal aflibercept during a 48-week follow-up using OCTA.Results: Twenty-six DME eyes from 26 patients were included (mean age, 64.6 years; women, 53.8%; prior anti-VEGF treatment, 46.1%). Each eye received a mean (SD) of 7.2 (2.2) injections. The parameters of the FAZ did not change during the 48-week follow-up: the mean (SD) FAZ area varied from 0.19 (0.19) mm2 at baseline (n=22) to 0.23 (0.20) mm2 at week 48 (n=15), boundary from 1.54 (1.21) to 2.04 (1.20) mm and circularity from 0.45 (0.33) % to 0.57 (0.20) %. There was no change in perfusion density and vessel density of the macula in the 3-mm circle. As expected, mean central retinal thickness, macular volume and visual acuity improved during follow-up. Discussion/Conclusion: No change in macular perfusion was observed in eyes with DME during a 48-week follow-up after intravitreal injections of aflibercept. Randomized controlled trials using OCT-angiography in large populations with extended observation periods are needed to assess changes in macular vessels after intravitreal anti-VEGF treatment.

Automated summary

Optical coherence tomography angiography (OCTA) was used to study changes in macular vessels in eyes with diabetic macular edema (DME) treated with aflibercept. The study found no change in macular perfusion and vessel density during a 48-week follow-up, but improvement in central retinal thickness, macular volume, and visual acuity.