May 2003
Volume 44, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2003
Fluocinolone Acetonide Intravitreal Implant in Patients with Diabetic Macular Edema: 12 Month Results
Author Affiliations & Notes
  • P. Pearson
    Ophthalmology Univ of Kentucky, University of Kentucky, Lexington, KY, United States
  • C.W. Baker
    Paducah Retinal Center, Paducah, KY, United States
  • D. Eliott
    Ophthalmology, Kresge Eye Institute, Wayne State University, Detroit, MI, United States
  • M.S. Ip
    Dept. of Ophthalmology and Visual Science, University of Wisconsin, Madison, WI, United States
  • L.S. Morse
    Dept. of Ophthalmology, University of California Davis, Sacramento, CA, United States
  • D. Callanan
    Texas Retina Associates, Arlington, TX, United States
  • Footnotes
    Commercial Relationships  P. Pearson, Control Delivery Systems I, C, P, R; Bausch & Lomb Inc. I, C, P, R; C.W. Baker, None; D. Eliott, Control Delivery Systems I; M.S. Ip, Bausch & Lomb Inc. C; L.S. Morse, None; D. Callanan, None.
Investigative Ophthalmology & Visual Science May 2003, Vol.44, 4288. doi:
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    • Get Citation

      P. Pearson, C.W. Baker, D. Eliott, M.S. Ip, L.S. Morse, D. Callanan; Fluocinolone Acetonide Intravitreal Implant in Patients with Diabetic Macular Edema: 12 Month Results . Invest. Ophthalmol. Vis. Sci. 2003;44(13):4288.

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

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Abstract

Abstract: : Purpose: A multicenter, randomized, controlled clinical trial is being conducted to investigate the use of a sustained release fluocinolone acetonide intravitreal implant in patients with diabetic macular edema. Methods: Eighty patients with a history of macular laser photocoagulation and refractory or recurrent diabetic macular edema were randomized into one of three study groups: 2mg implant dose group (n = 11), 0.5mg implant dose group (n = 41), and standard of care (SOC) group (n = 28). Standard of care treatment consisted of either macular grid laser or observation. Results: At 6 months, macular edema improved significantly in the 0.5mg implant group as compared to patients treated with standard of care (p<0.05). This improvement was further maintained at 12 months (p<0.01). The overall incidence of serious ocular adverse events at 12 months was 21.4% (6/28) in the SOC group and 43.9% (18/41) in the 0.5mg implant group. These serious adverse events included cataract development, 24.4% (10/41) in the 0.5mg implant group compared to 3.5% (1/28) in the SOC group and intraocular pressure rise (including glaucoma), 12.2% (5/41) in the 0.5mg implant group compared to 0% (0/28) in the SOC group. Conclusion: Treatment with a sustained release fluocinolone acetonide implant appears safe and effective in the studied patient population at 12 months. Dr. Pearson acknowledges a financial interest in the subject matter of this presentation.

Keywords: diabetic retinopathy • vitreoretinal surgery • immunomodulation/immunoregulation 
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