July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Fluocinolone acetonide (FAc) 0.2 mg intravitreal implant in the treatment of diabetic macular edema (DME)
Author Affiliations & Notes
  • John Liu
    Ophthalmology, Case Western Reserve University, Clevleand, Ohio, United States
  • Joseph Coney
    Retina Associates of Cleveland, Inc., Cleveland, Ohio, United States
  • Jerome Schartman
    Retina Associates of Cleveland, Inc., Cleveland, Ohio, United States
  • David G Miller
    Retina Associates of Cleveland, Inc., Cleveland, Ohio, United States
  • Hernando Zegarra
    Retina Associates of Cleveland, Inc., Cleveland, Ohio, United States
  • Llewelyn Rao
    Retina Associates of Cleveland, Inc., Cleveland, Ohio, United States
  • Footnotes
    Commercial Relationships   John Liu, None; Joseph Coney, Aerpio (F), Alimera (C), Genentech (C); Jerome Schartman, Aerpio (F); David Miller, Aerpio (F); Hernando Zegarra, Aerpio (F); Llewelyn Rao, Aerpio (F)
  • Footnotes
    Support  none
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 4816. doi:
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    • Get Citation

      John Liu, Joseph Coney, Jerome Schartman, David G Miller, Hernando Zegarra, Llewelyn Rao; Fluocinolone acetonide (FAc) 0.2 mg intravitreal implant in the treatment of diabetic macular edema (DME). Invest. Ophthalmol. Vis. Sci. 2018;59(9):4816.

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

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Abstract

Purpose : Clinical trials have shown the efficacy and safety of long-term implantable steroid devices in the treatment of DME. We performed a retrospective observational review to assess injection burden, macular edema, visual acuity, and intraocular pressure change in a real-world study of the efficacy and safety of FAc intravitreal implant.

Methods : Patients with any stage of diabetic retinopathy with central involving DME treated with at least one FAc intravitreal implant and with at least one year of follow-up were included in this analysis. Outcome measures included visual acuity (VA), central foveal thickness (CFT), intraocular pressure (IOP), and treatments required after one implant injection.

Results : Out of 63 patients who received FAc implant, 40 eyes in 33 patients met inclusion criteria. Average age was 66.85 years. Severity of disease before treatment had a slight bimodal distribution, with moderate NPDR (35%) and PDR (40%). The average baseline VA before implant was 66 letters and remained stable at 1 year with 67 letters (p=0.855) on average, approximately 20/50. Mean CFT just before implant was 430.9μ and reduced to 336.5μ (p=0.005) at 1 year. There was increase in IOP in 7 eyes that was controlled with 1 glaucoma drop; mean IOP before implant was 15.9mmHg and was stable throughout the year of follow-up (16.4mmHg at 1 year, p=0.873). In 9 eyes that were phakic before implant, there was no effect on lens clarity. The average number of anti-VEGF injections before implant was 1 treatment every 1.9 months; following FAc implant, 1 treatment every 6.6 months. The majority of eyes did not require additional anti-VEGF injections (60%).

Conclusions : In our population, FAc reduced the overall treatment burden for up to a year in eyes with DME. A majority (approximately 60%) of eyes required no additional treatment in a 12-month period. Mean VA was stable, and mean CFT was reduced. All patients benefited from this treatment with improved disease status as measured by CFT with no statistically significant side effects. Further study will allow us to better select patients who will benefit the most from FAc intravitreal implant.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

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