Preliminary results of an intravitreal dexamethasone implant (Ozurdex®) in patients with persistent diabetic macular edema

• Main Authors: Pacella E, Vestri AR, Muscella R, Carbotti MR, Castellucci M, Coi L, Turchetti P, Pacella F
• Format: Article
• Language: English
• Published: Dove Medical Press 2013-07-01
• Series: Clinical Ophthalmology
• Online Access: http://www.dovepress.com/nbsppreliminary-results-of-an-intravitreal-dexamethasone-implant-ozurd-a13681
• ISSN: 1177-5467; 1177-5483

Elena Pacella,1 Anna Rita Vestri,2 Roberto Muscella,1 Maria Rosaria Carbotti,1 Massimo Castellucci,1 Luigi Coi,1 Paolo Turchetti,3 Fernanda Pacella1&nbsp;1Department of Sense Organs, Faculty of Medicine and Dentistry, Sapienza University of Rome, Rome, Italy; 2Department of Public Health and Infectious Diseases, Faculty of Pharmacy and Medicine, Sapienza University of Rome, Rome, Italy; 3National Institute for Health, Migration and Poverty (INMP/NIHMP), Rome, ItalyBackground: To evaluate the efficacy and safety of an intravitreal dexamethasone implant (Ozurdex&reg;; Allergan Inc, Irvine, CA, USA) in patients with persistent diabetic macular edema (DME) over a 6-month follow-up period.Methods: Seventeen patients (20 eyes) affected by DME were selected. The mean age was 67 &plusmn; 8 years, and the mean duration of DME was 46.3 &plusmn; 18.6 months. The eligibility criteria were: age &ge;18, a best-corrected visual acuity between 5 and 40 letters, and macular edema with a thickness of &ge;275 &mu;m. Thirteen patients had also previously been treated with anti-vascular endothelial growth factor medication.Results: The mean ETDRS (Early Treatment Diabetic Retinopathy Study) value went from 18.80 &plusmn; 11.06 (T0) to 26.15 &plusmn; 11.03 (P = 0.04), 28.15 &plusmn; 10.29 (P = 0.0087), 25.95 &plusmn; 10.74 (P = 0.045), 21.25 &plusmn; 11.46 (P = 0.5) in month 1, 3, 4, and 6, respectively. The mean logMAR (logarithm of the minimum angle of resolution) value went from 0.67 &plusmn; 0.23 (at T0) to 0.525 &plusmn; 0.190 (P = 0.03), 0.53 &plusmn; 0.20 (P = 0.034), and 0.56 &plusmn; 0.22 (P = 0.12) in month 1, 3, and 4, respectively, to finally reach 0.67 &plusmn; 0.23 in month 6. The mean central macular thickness value improved from 518.80 &plusmn; 224.75 &mu;m (at T0) to 412.75 &plusmn; 176.23 &mu;m, 292.0 &plusmn; 140.8 &mu;m (P&nbsp;< 0.0001), and 346.95 &plusmn; 135.70 (P = 0.0018) on day 3 and in month 1 and 3, respectively, to then increase to 476.55 &plusmn; 163.14 &mu;m (P = 0.45) and 494.25 &plusmn; 182.70 &mu;m (P = 0.67) in month 4 and 6.Conclusion: The slow-release intravitreal dexamethasone implant, Ozurdex, produced significant improvements in best-corrected visual acuity and central macular thickness from the third day of implant in DME sufferers, and this improvement was sustained until the third month.Keywords: macular edema, diabetes, intravitreal implant, Ozurdex&reg;