A comparison study of Aflibercept and Dexamethasone intravitreal implant in the treatment of diabetes macular edema
Objective To compare the short-term efficacy and safety of Aflibercept alone or switched or combined with Dexamethasone intravitreal implant(DEX)in patients with diabetes macular edema(DME).Methods A prospec-tive comparison study.DME patients(59 cases,59 eyes)were randomly divided into simple group(20 eyes),switched group(19 eyes)and combined group(20 eyes).Each group received two monthly intravitreal injections of Aflibercept.For the third time,the simple group was injected with Aflibercept,the switched group was DEX,and the combined group was Aflibercept and DEX.The interval was 1 month,and the patients were followed up for 5 months from the first injection.All patients underwent best corrected visual acuity(BCVA),slit lamp,ophthalmoscopy,intraocular pressure(IOP),optical coherence tomography(OCT)and fluorescein fundus angiography(FFA)examination.The relevant data and complications were recorded,and the morphological changes of the macula were observed.They were compared and analyzed within and among the groups.Results There was no statistically significant difference in baseline data among the groups(P>0.05).logMAR BCVA,central macular thickness(CMT)and total macular volume(TMV)of the three groups every month after treatment were smaller than those before treatment,the difference was statistically significant(P<0.01).And there was no significant difference in logMAR BCVA among groups every month(P>0.05).The CMT of the switched and combined group was significantly lower than that of the simple group at 4 and 5 months after treatment(Pswitched=0.003,0.010,Pcombined=0.002,0.001).The TMV of the switched and combined group was significantly lower than that of the simple group at the 4-month(P=0.008,0.007),and the combined group was significantly lower than that of the simple group at the 5-month(P=0.015).Five months after the treatment,there was a significantly difference in CMT decrease(%)and TMV decrease(%)between the combined and simple group(Uc=7.377,8.473,P=0.025,0.014)and there was no significant difference in the decrease of CMT(µm)and TMV(mm3)among the three groups(Uc=1.604,5.398,P=0.448,0.067).The IOP of the combined group 4 months after the treatment was higher than that before the treatment(Z=2.013,P=0.044).Subconjuncti-val hemorrhage occurred in 3 eyes after DEX implantation,and mild tingling discomfort in 2 eyes after Aflibercept injec-tion.Conclusions Aflibercept alone or switcheded or combined with DEX can effectively reduce the height and range of DME.They can all improve vision acuity and be safe.The combined group demonstrated better morphological results.It was more meaningful to use the percentage of CMT and TMV decrease to measure the degree of DME regression.
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