To examine the efficacy of intravitreal aflibercept and navigated laser as compared to intravitreal aflibercept and conventional laser in diabetic macular oedema (DME) treatment. In 12-month randomized clinical trial, 48 eyes of 37 patients with centre-involved DME at Odense University Hospital were randomized 1:1 to receive three monthly injections of aflibercept followed by navigated (group A) or conventional (group B) focal/grid laser. From month four through twelve, patients were examined monthly, and additional injections were given pro re nata (PRN) (central retinal thickness [CRT]>20% from lowest measurement or loss in visual acuity [VA]>5 Early Treatment Diabetic Retinopathy Study [ETDRS] letters compared with baseline). Outcome measures; (1) percentage of eyes that needed additional injections after laser in group A and B, (2) mean number of injections in group A and B, and (3) mean change in VA and CRT in group A and B. In the PRN phase, 60.5% of patients needed additional injections without differences between groups A and B (58.3 versus 63.2%, p>0.99). The mean number of injections between baseline and month 12 was 4.4 (4.2 versus 4.6, p=0.41). From baseline to month 12, VA improved by 8.4 ETDRS letters, and CRT was reduced by 97.4μm (+9.4 versus +7.1 letters, p=0.17, and -83.2 versus -115.4μm, p=0.21). No difference in need for retreatment was detected between treatment arms of aflibercept and navigated versus conventional laser.
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