Aflibercept and navigated versus conventional laser in diabetic macular oedema: a 12-month randomized clinical trial.

Abstract

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.