Skip to main content
Journal cover image

Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study.

Publication ,  Journal Article
Jaffe, GJ; Martin, D; Callanan, D; Pearson, PA; Levy, B; Comstock, T; Fluocinolone Acetonide Uveitis Study Group,
Published in: Ophthalmology
June 2006

PURPOSE: To report the interim 34-week safety and efficacy results of a 3-year study to evaluate an investigational intravitreal fluocinolone acetonide (FA) implant in patients with noninfectious posterior uveitis. DESIGN: Prospective, dose-masked, dose-randomized, historically controlled, multicenter trial in patients with unilateral or bilateral disease. PARTICIPANTS: A total of 278 patients with recurrent noninfectious posterior uveitis were randomized to receive a 0.59-mg (n = 110) or 2.1-mg (n = 168) implant. In patients with bilateral disease, the more severely affected eye received the implant. METHODS: The implant was inserted surgically into the vitreous cavity through a pars plana incision. Follow-up visits were scheduled on day 2, week 1, and then every 4 to 6 weeks through 34 weeks after implantation. Systemic, periocular, and topical therapies were reduced as allowed by the clinical response. MAIN OUTCOME MEASURES: The primary efficacy outcome was a comparison of the recurrence rate in the implanted eye from the 34 weeks before implantation to the 34 weeks after implantation. Visual acuity (VA), need for adjunctive therapy, and safety also were assessed. RESULTS: Combining both doses, the FA implant reduced the rate of recurrences from 51.4% in the 34 weeks preceding implantation to 6.1% postimplantation (P<0.0001) in the study eyes. Comparatively, there was a significant increase in the recurrence rate in the fellow nonimplanted eyes from 20.3% preimplantation to 42.0% postimplantation (P<0.0001). Visual acuity was stabilized or improved in 87% of implanted eyes and generally was associated with reductions in the area of macular hyperfluorescence. The percentage of eyes that required systemic medications, periocular injections, and topical corticosteroids decreased from 52.9%, 63.0%, and 35.7%, respectively, preimplantation to 12.1%, 2.2%, and 16.5% postimplantation (P< or =0.0001 in all cases). At week 34, 51.1% of implanted eyes required ocular antihypertensive drops, and 5.8% underwent glaucoma filtering surgery. Lens opacity scores increased by > or =2 grades in 19.8% of phakic implanted eyes, and 9.9% required cataract surgery. There were no statistically significant differences in any of the parameters studied for the 0.59-mg implant, compared with the 2.1-mg implant. CONCLUSIONS: The FA implant significantly reduced uveitis recurrences, improved VA, and decreased the need for adjunctive therapy in the studied patient population. The most common side effects included increased intraocular pressure and cataract progression.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

June 2006

Volume

113

Issue

6

Start / End Page

1020 / 1027

Location

United States

Related Subject Headings

  • Visual Acuity
  • Uveitis, Posterior
  • Treatment Outcome
  • Recurrence
  • Prospective Studies
  • Ophthalmology & Optometry
  • Middle Aged
  • Male
  • Lens, Crystalline
  • Intraocular Pressure
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Jaffe, G. J., Martin, D., Callanan, D., Pearson, P. A., Levy, B., Comstock, T., & Fluocinolone Acetonide Uveitis Study Group, . (2006). Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology, 113(6), 1020–1027. https://doi.org/10.1016/j.ophtha.2006.02.021
Jaffe, Glenn J., Daniel Martin, David Callanan, P Andrew Pearson, Brian Levy, Timothy Comstock, and Timothy Fluocinolone Acetonide Uveitis Study Group. “Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study.Ophthalmology 113, no. 6 (June 2006): 1020–27. https://doi.org/10.1016/j.ophtha.2006.02.021.
Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T, et al. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020–7.
Jaffe, Glenn J., et al. “Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study.Ophthalmology, vol. 113, no. 6, June 2006, pp. 1020–27. Pubmed, doi:10.1016/j.ophtha.2006.02.021.
Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T, Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020–1027.
Journal cover image

Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

June 2006

Volume

113

Issue

6

Start / End Page

1020 / 1027

Location

United States

Related Subject Headings

  • Visual Acuity
  • Uveitis, Posterior
  • Treatment Outcome
  • Recurrence
  • Prospective Studies
  • Ophthalmology & Optometry
  • Middle Aged
  • Male
  • Lens, Crystalline
  • Intraocular Pressure