Preliminary results of an intravitreal dexamethasone implant (Ozurdex®) in patients with persistent diabetic macular edema
Authors Pacella E, Vestri AR, Muscella R, Carbotti MR, Castellucci M, Coi L, Turchetti P, Pacella F
Received 15 May 2013
Accepted for publication 20 June 2013
Published 16 July 2013 Volume 2013:7 Pages 1423—1428
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 5
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
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, Italy
Background: To evaluate the efficacy and safety of an intravitreal dexamethasone implant (Ozurdex®; 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 ± 8 years, and the mean duration of DME was 46.3 ± 18.6 months. The eligibility criteria were: age ≥18, a best-corrected visual acuity between 5 and 40 letters, and macular edema with a thickness of ≥275 μm. 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 ± 11.06 (T0) to 26.15 ± 11.03 (P = 0.04), 28.15 ± 10.29 (P = 0.0087), 25.95 ± 10.74 (P = 0.045), 21.25 ± 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 ± 0.23 (at T0) to 0.525 ± 0.190 (P = 0.03), 0.53 ± 0.20 (P = 0.034), and 0.56 ± 0.22 (P = 0.12) in month 1, 3, and 4, respectively, to finally reach 0.67 ± 0.23 in month 6. The mean central macular thickness value improved from 518.80 ± 224.75 μm (at T0) to 412.75 ± 176.23 μm, 292.0 ± 140.8 μm (P < 0.0001), and 346.95 ± 135.70 (P = 0.0018) on day 3 and in month 1 and 3, respectively, to then increase to 476.55 ± 163.14 μm (P = 0.45) and 494.25 ± 182.70 μm (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®
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