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AIM: To evaluate the long-term efficacy and safety of dexamethasone implants in subjects affected by diabetic macular edema(DME) resistant to anti-vascular endothelial growth factor(VEGF) therapy.METHODS: Thirty-two DME patients were enrolled.A700 microgram slow release Intravitreal Dexamethasone Implant(Ozurdex~) was placed in the vitreous cavity.All patients were followed for 18 mo.Best-corrected visual acuity(BCVA) measured with Early Treatment Diabetic Retinopathy Study(ETDRS) and central macular thickness(CMT) exams were carried out at baseline(T0)and after 1(T1),3(T3),4(T4),6(T6),9(T9),12(T12),15(T15),and 18mo(T18) post injection. RESULTS: Repeated measures ANOVA showed an effect of treatment on ETDRS(P<0.0001).Post hoc analyses revealed that ETDRS values were significantly increased at T1,T3,T4,T9,and T15(P <0.001) as compared to baseline value(T0).At T6,T12,and T18,ETDRS values were still statistically higher than baseline(P<0.001 vs T0).However,at these time points,we observed a trend to return to baseline conditions.ANOVA also showed an effect of treatment(P <0.0001).CMT decreased significantly at T1,T3,T4,T9,and T15(P<0.001).At T6(P<0.01),T12 and T18(P<0.001) CMT was also significantly lower than T0 although a trend to return to the baseline conditions was also observed.CONCLUSION: Our findings demonstrate that Intravitreal Dexamethasone Implant is a good option to improveBCVA and CMT in DME patients resistant to anti-VEGF therapy.Our data also show that the use of drugs administered directly into the vitreous allows achieving appropriate and long-lasting concentration at the site of disease without systemic side effects.
AIM: To evaluate the long-term efficacy and safety of dexamethasone implants in subjects affected by diabetic macular edema (DME) resistant to anti-vascular endothelial growth factor (VEGF) therapy. METHODS: Thirty-two DME patients were enrolled. A700 microgram slow The release Intravitreal Dexamethasone Implant (Ozurdex ~ ) was placed in the vitreous cavity. All patients were followed for 18 mo. Best-corrected visual acuity (BCVA) measured with Early Treatment Diabetic Retinopathy Study (ETDRS) and central macular thickness (CMT) exams were carried out at baseline (T0) and after 1 (T1), 3 (T3), 4 (T4), 6 (T6), 9 (T9), 12 (T12), 15 (T15) Post hoc analyzes revealed that ETDRS values were significantly increased at T1, T3, T4, T9, and T15 (P <0.001) as compared to At T time values, we observe baseline values (T0). At T6, T12, and T18, ETDRS values were still higher than baseline (P <0.001 vs. T0) (P <0.001) .At T6 (P <0.01), while TTC decreased significantly (P < T12 and T18 (P <0.001) CMT was also significantly lower than T0 although a trend to return to the baseline conditions was also observed. CONCLUSION: Our findings demonstrate that Intravitreal Dexamethasone Implant is a good option to improve BCVA and CMT in DME patients resistant to anti-VEGF therapy. Our data also show that the use of drugs administered directly into the vitreous allows achieving the appropriate and long-lasting concentration at the site of disease without systemic side effects.