May 2004
Volume 45, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2004
Fluocinolone Acetonide Intravitreal Implant for Uveitis Affecting the Posterior Segment of the Eye
Author Affiliations & Notes
  • G. Jaffe
    Ophthalmology, Duke University Med Center, Durham, NC
  • Fluocinolone Acetonide Uveitis Study Group
    Ophthalmology, Duke University Med Center, Durham, NC
  • Footnotes
    Commercial Relationships  G. Jaffe, Bausch & Lomb Inc. C; Control Delivery Systems Inc. I, C.
  • Footnotes
    Support  none
Investigative Ophthalmology & Visual Science May 2004, Vol.45, 3369. doi:
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    • Get Citation

      G. Jaffe, Fluocinolone Acetonide Uveitis Study Group; Fluocinolone Acetonide Intravitreal Implant for Uveitis Affecting the Posterior Segment of the Eye . Invest. Ophthalmol. Vis. Sci. 2004;45(13):3369.

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

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Abstract

Abstract: : Purpose: A multi–center, randomized, dose–masked clinical trial was conducted to determine the safety and efficacy of a sustained release fluocinolone acetonide intravitreal implant in patients with posterior segment uveitis. Methods: Two hundred and seventy eight patients were randomized to receive either a 0.5mg or 2.0mg implant. Outcome measures included recurrence rate, visual acuity, adjunctive therapy use and adverse events. Results: At 34 weeks post implantation, the aggregate recurrence rate for the implanted eyes was 2.9% versus 43.7% for the non–implanted fellow eyes (p<0.0001). Aggregate mean visual acuity significantly improved from 20/68 to 20/58 at 34 weeks in the study eyes (p=0.001). Adjunctive therapy use also significantly decreased post implantation. Systemic corticosteroid and/or immunosuppressive therapy was used by 59.0% of patients at baseline versus 13.7% of patients at 34 weeks (p<0.0001). In the 12 months prior to implantation, 70.5% of study eyes were given sub–Tenon injections versus 2.2% post implantation (p<0.0001). Similarly, topical steroid use was also reduced; 28.7% of study eyes at baseline versus 8.3% at 34 weeks (p<0.0001). The most common serious adverse events included cataract extraction (13.5%) and filtering procedures (8.6%). Conclusion: At 34 weeks, the fluocinolone acetonide implant controlled inflammation and resulted in visual acuity improvement in a significant proportion of the eyes studied. IOP and lens clarity must be closely monitored in this patient population. The 1 year extended follow–up results will be presented.

Keywords: inflammation • vitreoretinal surgery • corticosteroids 
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