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

Elena Pacella, Anna Rita Vestri, Roberto Muscella, Maria Rosaria Carbotti, Massimo Castellucci, Luigi Coi, Paolo Turchetti, Fernanda Pacella, Elena Pacella, Anna Rita Vestri, Roberto Muscella, Maria Rosaria Carbotti, Massimo Castellucci, Luigi Coi, Paolo Turchetti, Fernanda Pacella

Abstract

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: Ozurdex®; diabetes; intravitreal implant; macular edema.

Figures

Figure 1
Figure 1
Graph showing trend in ETDRS values. Notes: *P ≤ 0.05; **P ≤ 0.01. Abbreviation: ETDRS, Early Treatment Diabetic Retinopathy Study.
Figure 2
Figure 2
Graph showing trend in logMAR values. Note: *P ≤ 0.05. Abbreviation: logMAR, logarithm of the minimum angle of resolution.
Figure 3
Figure 3
Graph showing trend in CMT values. Notes: **P ≤ 0.01; ***P ≤ 0.001. Abbreviation: CMT, central macular thickness.
Figure 4
Figure 4
Optical coherence tomography images of a patient with persistent diabetic macular edema. OD (right eye) central macular thickness: (A), baseline; (B), 1 month after treatment; (C), 3 months after treatment; (D), 6 months after treatment.

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