Use of the Fluocinolone Acetonide Intravitreal Implant for the Treatment of Noninfectious Posterior Uveitis: 3-Year Results of a Randomized Clinical Trial in a Predominantly Asian Population

Virender S. Sangwan, P. Andrew Pearson, Hemanth Paul, Timothy L. Comstock

Research output: Contribution to journalArticlepeer-review

31 Scopus citations

Abstract

Introduction: The fluocinolone acetonide (FA) intravitreal implant 0.59 mg (Retisert®, Bausch + Lomb, Rochester, NY, USA) provides sustained release of FA directly to the vitreous cavity over a prolonged period of time. The purpose of this study was to evaluate the safety and efficacy of a 0.59- and 2.1-mg FA intravitreal implant in patients with noninfectious posterior uveitis. Methods: A prospective, multicenter, randomized, double-masked, dose-controlled study was performed. Patients were randomized to the 0.59- or 2.1-mg FA implant surgically placed in the vitreous cavity through a pars plana incision and were evaluated at visits through 3 years. Patients with bilateral disease had the more severely affected eye implanted. Outcomes included uveitis recurrence rate, best-corrected visual acuity (BCVA), use of adjunctive therapy, and safety. Results: A total of 239 patients, predominantly Asian, were implanted (n = 117, 0.59-mg implant; n = 122, 2.1-mg implant). Approximately 80% of patients had bilateral disease. Recurrence rates for implanted eyes decreased from 42.3% during the 1-year pre-implantation period to 25.9% during the 3-year post-implantation period (P = 0.0003) and increased for nonimplanted fellow eyes from 19.8 to 59.7% (P < 0.0001). More implanted eyes gained ≥3 lines of BCVA compared to nonimplanted fellow eyes (P ≤ 0.0046); and implanted eyes required less adjunctive systemic therapy and fewer periocular injections (P < 0.0001). Elevations of intraocular pressure (≥10 mm Hg) were frequent in implanted eyes (67.8%, 0.59-mg implant; 71.3%, 2.1-mg implant); nearly all (94.9%) phakic implanted eyes required cataract surgery. Conclusion: The FA intravitreal implant significantly reduced uveitis recurrence rates and led to improvements in visual acuity and reductions in adjunctive therapy. Lens clarity and intraocular pressure require monitoring.

Original languageEnglish
Pages (from-to)1-19
Number of pages19
JournalOphthalmology and Therapy
Volume4
Issue number1
DOIs
StatePublished - Jun 19 2015

Bibliographical note

Publisher Copyright:
© 2014, The Author(s).

Keywords

  • Adjunctive therapy
  • Asian population
  • Fluocinolone acetonide intravitreal implant
  • Posterior uveitis
  • Randomized clinical trial
  • Retisert
  • Uveitis recurrence

ASJC Scopus subject areas

  • Ophthalmology

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