April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
Three-year, Randomized, Sham-controlled, Phase III Study of Dexamethasone Intravitreal Implant in Patients with Diabetic Macular Edema
Author Affiliations & Notes
  • Rubens Belfort, Jr.
    Ophthalmology, Federal University of Sao Paulo, Sao Paulo, Brazil
  • David S Boyer
    Retina-Vitreous Associates Medical Group, Los Angeles, CA
  • Young Hee Yoon
    Asan Medical Center, University of Ulsan, Seoul, Republic of Korea
  • Francesco Bandello
    Hospital San Raffaele, University Vita Salute, Milan, Italy
  • Raj K Maturi
    Midwest Eye Institute, Indianapolis, IN
  • Albert J Augustin
    Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany
  • Xiao-Yan Li
    Allergan, Inc., Irvine, CA
  • Harry Cui
    Allergan, Inc., Irvine, CA
  • Yehia Hashad
    Allergan, Inc., Irvine, CA
  • Scott M Whitcup
    Allergan, Inc., Irvine, CA
  • Footnotes
    Commercial Relationships Rubens Belfort, Jr., Allergan, Inc. (C), Allergan, Inc. (F), Allergan, Inc. (R); David Boyer, Allergan, Inc. (C), Allergan, Inc. (F), Allergan, Inc. (R); Young Hee Yoon, Allergan, Inc. (C), Allergan, Inc. (R); Francesco Bandello, Allergan, Inc. (C), Allergan, Inc. (R); Raj Maturi, Allergan, Inc. (C); Albert Augustin, Allergan, Inc. (F), Allergan, Inc. (R); Xiao-Yan Li, Allergan, Inc. (E); Harry Cui, Allergan, Inc. (E); Yehia Hashad, Allergan, Inc. (E); Scott Whitcup, Allergan, Inc. (E)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 1706. doi:
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      Rubens Belfort, Jr., David S Boyer, Young Hee Yoon, Francesco Bandello, Raj K Maturi, Albert J Augustin, Xiao-Yan Li, Harry Cui, Yehia Hashad, Scott M Whitcup, ; Three-year, Randomized, Sham-controlled, Phase III Study of Dexamethasone Intravitreal Implant in Patients with Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1706.

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

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Abstract

Purpose: To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 mg and 0.35 mg in the treatment of diabetic macular edema (DME).

Methods: Pooled data analysis of results from two 3-year, randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols. Patients (n=1048) with DME, best-corrected visual acuity (BCVA) between 34 and 68 ETDRS letters, and central subfield retinal thickness (CRT) ≥300 µm by optical coherence tomography (OCT) were randomized in a 1:1:1 ratio to treatment with DEX implant 0.7 mg, DEX implant 0.35 mg, or sham procedure. Patients who met retreatment eligibility criteria could be retreated no more often than every 6 months. The primary endpoint for the United States FDA was achievement of ≥15-letter improvement in BCVA from baseline at study end in the intent-to-treat population with last-observation-carried-forward for missing values. Safety measures included adverse events (AEs) and intraocular pressure (IOP).

Results: Mean number of treatments received over 3 years was 4.1 for DEX implant 0.7 mg, 4.4 for DEX implant 0.35 mg, and 3.3 for sham. The percentage of patients with ≥15-letter improvement in BCVA from baseline at study end was greater with DEX implant 0.7 mg (22.2%) and DEX implant 0.35 mg (18.4%) than sham (12.0%) (P≤0.018). Mean average reduction in CRT from baseline during the study was greater with DEX implant 0.7 mg (-111.6 µm) and DEX implant 0.35 mg (-107.9 µm) than sham (-41.9 µm) (P<0.001, area-under-the-curve approach). Rates of cataract-related AEs in phakic eyes were 67.9%, 64.1%, and 20.4% in the DEX implant 0.7 mg, DEX implant 0.35 mg, and sham groups, respectively. IOP increases were usually controlled with medication or no therapy; only 1 (0.3%) patient treated with DEX implant 0.7 mg and 1 (0.3%) treated with DEX implant 0.35 mg underwent glaucoma incisional surgery for steroid-induced IOP increases.

Conclusions: DEX implant 0.7 mg and 0.35 mg provided statistically and clinically significant improvement in BCVA and reduction in CRT with an average of only 4-5 injections over 3 years. The safety profile was favorable.

Keywords: 499 diabetic retinopathy • 487 corticosteroids • 505 edema  
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