Purpose : To investigate efficacy and safety of repeated dexamethasone (DEX) implants over 24 months in a real-life environment, in diabetic macular edema (DME) eyes that were treatment-naïve compared to eyes refractory to anti-VEGF treatment. Methods : This multicenter international retrospective study assessed best corrected visual acuity (BCVA) and central subfield thickness (CST) of naïve and refractory eyes to anti-VEGF injections treated with DEX implants. Safety data (intraocular pressure rise and cataract surgery) were recorded. Results : 130 eyes from 125 patients were included. Baseline BCVA and CST were similar for naïve and refractory eyes. Both groups improved significantly in vision after 24 months (p< 0.001). However, naïve eyes gained statistically significant more vision than refractory eyes (BCVA 0.36 ± 0.14 versus 0.47 ± 0.23 logMAR, p=0.005) and were more likely to gain ≥ 10 letters (OR 4.2, 95% CI 1.38 - 12.90, p=0.01). At 6, 12 and 24 months, CST was significantly decreased compared to baseline in both naïve and refractory eyes; however, CST was increased in refractory compared to naïve eyes (CST 279 ± 61 versus 313 ± 125, p=0.06). Conclusions : Over a follow up of 24 months, vision improved in DME eyes following treatment with DEX implants, both in eyes that were treatment-naïve and eyes refractory to anti-VEGF treatment; however, improvement was greater in naïve eyes
Dexamethasone Implant for Diabetic Macular Edema in Naïve Compared To Refractory Eyes –A 24 Month The International Retina Group Real-Life Multicenter Study - IRGRel-DEX Study
Ermete Giancipoli;
2018-01-01
Abstract
Purpose : To investigate efficacy and safety of repeated dexamethasone (DEX) implants over 24 months in a real-life environment, in diabetic macular edema (DME) eyes that were treatment-naïve compared to eyes refractory to anti-VEGF treatment. Methods : This multicenter international retrospective study assessed best corrected visual acuity (BCVA) and central subfield thickness (CST) of naïve and refractory eyes to anti-VEGF injections treated with DEX implants. Safety data (intraocular pressure rise and cataract surgery) were recorded. Results : 130 eyes from 125 patients were included. Baseline BCVA and CST were similar for naïve and refractory eyes. Both groups improved significantly in vision after 24 months (p< 0.001). However, naïve eyes gained statistically significant more vision than refractory eyes (BCVA 0.36 ± 0.14 versus 0.47 ± 0.23 logMAR, p=0.005) and were more likely to gain ≥ 10 letters (OR 4.2, 95% CI 1.38 - 12.90, p=0.01). At 6, 12 and 24 months, CST was significantly decreased compared to baseline in both naïve and refractory eyes; however, CST was increased in refractory compared to naïve eyes (CST 279 ± 61 versus 313 ± 125, p=0.06). Conclusions : Over a follow up of 24 months, vision improved in DME eyes following treatment with DEX implants, both in eyes that were treatment-naïve and eyes refractory to anti-VEGF treatment; however, improvement was greater in naïve eyesI documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
