Diabetic macular oedema is a leading cause of visual impairment in the working aged population in developed countries. It was established by the Early Treatment Diabetic Retinopathy Study that focal/grid laser photocoagulation reduces the risk of visual loss in patients with centre‐involving DME but with a small likelihood of visual improvement. Currently, vascular endothelial growth factor inhibitors are the established first line of treatment and have consistently demonstrated efficacy in DME treatment. However, a high number of injections are needed to sustain visual improvement. Whereas the efficacy of focal/grid laser photocoagulation is modest in regard to visual improvement, its protracted effect is a desired shortcoming of current anti‐VEGF agents.
Hence, combination therapy could be attractive to relieve the burden of repetitive intravitreal injections. However, most attempts with combination therapy for DME have so far not been able to reduce the need of intravitreal therapy. Modern navigated laser photocoagulation systems benefit from technical advantages of integrated software which allows for capture and/or import and overlay of, for example fundus fluorescein angiography images and optical coherence tomography thickness maps.
In a 12‐month prospective randomized clinical trial of patients with centre‐involving DME, we aimed to compare the percentage of eyes that needed additional aflibercept injections after laser at month 12 (primary outcome) and the mean number of injections and mean change in visual acuity and central retinal thickness (CRT) between baseline and month 12 (secondary outcomes) in treatment arms of intravitreal aflibercept and navigated laser vs intravitreal aflibercept and conventional laser. Aflibercept was chosen over ranibizumab as aflibercept is often the drug of choice in clinical practice and due to the 1‐year results reported from the DRCR.net protocol T trial.