April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
Anatomic Outcomes with Dexamethasone Intravitreal Implant in Diabetic Macular Edema: a Pooled Analysis of Two Randomized Phase 3 Trials
Author Affiliations & Notes
  • Ronald P Danis
    Ophthalmology & Visual Sciences, Univ of Wisconsin-Madison, Madison, WI
  • Srinivas R Sadda
    Doheny Eye Institute, Los Angeles, CA
  • Harry Cui
    Allergan, Inc., Irvine, CA
  • Xiao-Yan Li
    Allergan, Inc., Irvine, CA
  • Yehia Hashad
    Allergan, Inc., Irvine, CA
  • Scott M Whitcup
    Allergan, Inc., Irvine, CA
  • Footnotes
    Commercial Relationships Ronald Danis, Allergan, Inc. (C), Allergan, Inc. (F); Srinivas Sadda, Allergan, Inc. (C), Allergan, Inc. (F), Genentech (C), Genentech (F); Harry Cui, Allergan, Inc. (E); Xiao-Yan Li, Allergan, Inc. (E); Yehia Hashad, Allergan, Inc. (E); Scott Whitcup, Allergan, Inc. (E)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 5051. doi:
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    • Get Citation

      Ronald P Danis, Srinivas R Sadda, Harry Cui, Xiao-Yan Li, Yehia Hashad, Scott M Whitcup, ; Anatomic Outcomes with Dexamethasone Intravitreal Implant in Diabetic Macular Edema: a Pooled Analysis of Two Randomized Phase 3 Trials. Invest. Ophthalmol. Vis. Sci. 2014;55(13):5051.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: To assess anatomic outcomes with dexamethasone intravitreal implant [DEX implant] (Ozurdex®, Allergan Inc., Irvine, CA) 0.7 and 0.35 mg in the treatment of diabetic macular edema (DME).

Methods: Two multicenter, randomized, sham-controlled Phase 3 trials of DEX implant (NCT00168337 and NCT00168389), with identical protocols, were conducted and data were pooled for analysis. Patients with DME, best-corrected visual acuity (BCVA) of 34 - 68 letters (20/200 - 20/50 Snellen equivalent), and retinal thickness in the 1-mm central subfield (CRT) ≥300 µm were randomized to treatment with DME implant 0.7 mg, DEX implant 0.35 mg, or sham procedure and followed for 3 years. Study visits occurred at 6-week (Year 1) and 3-month (Years 2 and 3) intervals; retreatment was permitted at ≥6-month intervals. Time-domain optical coherence tomography and fundus photography images were evaluated by a central reading facility.

Results: The study eye of 1048 patients (mean age 62.4 years) received (mean) 4.1, 4.4, and 3.3 treatments with DEX 0.7 mg implant, DEX 0.35 mg implant, and sham, respectively, over 3 years. At all time points DEX 0.7mg and 0.35 mg implant reduced CRT (mean change from baseline to study end: -117.3 and -127.8 µm, respectively; mean average change [area-under-curve approach] over study period: -111.6 and -107.9 µm, respectively; all P<0.001 vs sham), and reduced macular volume (mean change from baseline to study end: -1.06 and -1.14 mm3, respectively; both P<0.001 vs sham). DEX 0.7 mg and 0.35 mg implant reduced disc areas of macular thickening on color photographs (mean change from baseline to study end: -2.753 and -2.931, respectively; both P<0.001 vs sham). More DEX 0.7mg and 0.35 mg implant- than sham-treated eyes showed improvement in clinically significant macular edema (retinal thickening ≥1 disc area, part ≤1 disc diameter from center, or retinal thickening or adjacent hard exudates ≤500 μm from center) (20.4% and 22.4%, respectively, vs 12.4% at study end; both P<0.05 vs sham). DEX 0.7mg implant reduced the risk in time to 2-step worsening in Diabetic Retinopathy Severity Score by 44% over the study period (P=0.03 vs sham).

Conclusions: DEX 0.7 mg or 0.35 mg implant, administered at ≥6-month intervals over 3 years, provided rapid and sustained improvement in retinal thickening and delayed progression of retinopathy in patients with DME.

Keywords: 550 imaging/image analysis: clinical • 487 corticosteroids • 499 diabetic retinopathy  
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