Paulo Mello Filho1, Gabriel Andrade2, Andre Maia1, Mauricio Maia1, Laurentino Biccas Neto1, Acacio Muralha Neto3, Oswaldo Moura Brasil4, Eduardo Minelli5, Claudio Dalloul6, Matias Iglicki7. 1. Department of Ophthalmology, Federal University of São Paulo, São Paulo, Brazil. 2. Department of Ophthalmology, Federal University of São Paulo, São Paulo, Brazil, drgabrielandrade@gmail.com. 3. Department of Ophthalmology, Rio de Janeiro State University, Rio de Janeiro, Brazil. 4. Brazilian Institute of Ophthalmology, Rio de Janeiro, Brazil. 5. HCLOE Clinic, São Paulo, Brazil. 6. D'Olhos Hospital, São José do Rio Preto, Brazil. 7. Retina Private Office, Buenos Aires, Argentina.
Abstract
INTRODUCTION: There are few real-life studies on the intravitreal 0.7-mg dexamethasone implant for the treatment of diabetic macular edema (DME) conducted in Latin America. We aimed to assess the effectiveness and safety of this implant in clinical practice. METHODS: Twenty-seven centers from Brazil and one from Argentina provided information on patients with DME treated with Ozurdex. The efficacy outcome variables were best-corrected visual acuity (BCVA) in Snellen and central retinal thickness (CRT). Safety was assessed by the elevation in intraocular pressure (IOP), occurrence of cataracts, and adverse events. RESULTS: A total of 329 eyes (both treated cases and naïve eyes) from 282 patients underwent treatment. The time since diagnosis of DME ranged from 1 to 156 months. The median BCVA was 0.7 logMAR/50 letters at baseline and 0.3 logMAR/70 letters after treatment (both p < 0.001). Median CRT values decreased from 425 µm at baseline to 270 µm after treatment (p < 0.001). Increases in IOP of at least 10 mm Hg were observed in 7.4% of eyes, and 4% of eyes had cataract evolution. No cases of endophthalmitis were reported. CONCLUSION: These real-life results suggest that the intravitreal dexamethasone implant is effective and safe for eyes with DME.
INTRODUCTION: There are few real-life studies on the intravitreal 0.7-mg dexamethasone implant for the treatment of diabetic macular edema (DME) conducted in Latin America. We aimed to assess the effectiveness and safety of this implant in clinical practice. METHODS: Twenty-seven centers from Brazil and one from Argentina provided information on patients with DME treated with Ozurdex. The efficacy outcome variables were best-corrected visual acuity (BCVA) in Snellen and central retinal thickness (CRT). Safety was assessed by the elevation in intraocular pressure (IOP), occurrence of cataracts, and adverse events. RESULTS: A total of 329 eyes (both treated cases and naïve eyes) from 282 patients underwent treatment. The time since diagnosis of DME ranged from 1 to 156 months. The median BCVA was 0.7 logMAR/50 letters at baseline and 0.3 logMAR/70 letters after treatment (both p < 0.001). Median CRT values decreased from 425 µm at baseline to 270 µm after treatment (p < 0.001). Increases in IOP of at least 10 mm Hg were observed in 7.4% of eyes, and 4% of eyes had cataract evolution. No cases of endophthalmitis were reported. CONCLUSION: These real-life results suggest that the intravitreal dexamethasone implant is effective and safe for eyes with DME.