To evaluate the clinical efficacy and safety of Lucentis (Lu) combined with triamcinolone acetonide (TA) in the treatment of visual impairment caused by diffuse diabetic macular edema (DME).

From January 2017 to October 2018, 78 patients (90 eyes) with DME treated at the Department of Ophthalmology of Huadu Hospital Affiliated to Southern Medical University were randomly divided into an Lu group, TA group, and Lu+ TA group, in which Lucentis (0.5 mg/0.05 mL), TA (2 mg/0.05 ml), and Lucentis (0.5 mg/0.05 ml) plus TA (2 mg/0.05 ml) were injected into the vitreous cavity, respectively. Before treatment and 1 day, 1 week, 1 month, and 3 months after treatment, the best corrected visual acuity, central retinal thickness, intraocular pressure, degree of ocular fundus macular edema, and leakage type were measured, and radial vein blood was collected at each time point. Serum levels of vascular endothelial growth factor (VEGF), tumor necrosis factor-α (TNF-α), and interleukin-1β (IL-1β) were measured by enzyme-linked immunosorbent assay (ELISA), and the apoptosis of neutrophils in peripheral blood was analyzed by flow cytometry. Single-factor ANOVA and t-test were used to compare the best corrected visual acuity, retinal thickness of macular center, intraocular pressure, degree of macular edema, and the levels of VEGF, TNF-α, and IL-1β in and between groups.

There was no significant difference in the mean best corrected visual acuity among the three groups before treatment (P>0.05). The best corrected visual acuity improved significantly at 1 day, 1 week, 1 month, and 3 months after treatment, and there was a significant difference between the Lu+ TA group and Lu group at different time points (P<0.05). There was no significant difference in macular central retinal thickness among the three groups before treatment (P>0.05). The retinal thickness at 1 day, 1 week, 1 month, and 3 months after treatment was significantly lower than that before treatment (P<0.05). There was no significant difference in retinal thickness between among the three groups before treatment (P<0.05), but there was a significant difference between the Lu+ TA group and Lu group at different time points (P<0.05). There was no significant difference in intraocular pressure (IOP), degree of fundus macular edema, or leakage type among the three groups before treatment (P>0.05), but IOP, fundus macular edema degree, and leakage type at 3 months after treatment were significantly different from those before treatment (P<0.05). There was no significant difference in serum VEGF, TNF-α, IL-1β, or neutrophil apoptosis among the three groups before treatment, but serum VEGF, TNF-α, and IL-1β as well as the apoptosis of peripheral blood neutrophils at 1 day, 1 week, 1 month, and 3 months after treatment were significantly higher than those before treatment (P<0.05), and there was a significant difference between the Lu + TA group and Lu group at different time points (P<0.05).

Lu combined with TA can control diabetic macular edema, improve the best corrected visual acuity and macular thickness, and decrease the degree of macular edema in DME patients. Lu combined with TA is superior to Lu and TA alone in the treatment of diabetic macular edema, because intra-vitreous Lu and TA vitreous injection have a synergetic effect. In addition, the combination therapy can reduce the levels of VEGF and inflammatory factors in patients with DME.