Elsevier

Ophthalmology

Volume 113, Issue 6, June 2006, Pages 1020-1027
Ophthalmology

Original Article
Fluocinolone Acetonide Implant (Retisert) for Noninfectious Posterior Uveitis: Thirty-Four–Week Results of a Multicenter Randomized Clinical Study

Aggregate dose data presented in part at: American Academy of Ophthalmology Annual Meeting, November, 2003; Anaheim, California.
https://doi.org/10.1016/j.ophtha.2006.02.021Get rights and content

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≤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 ≥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.

Section snippets

Setting

This is a 3-year, prospective, dose-randomized, dose-masked trial in patients with unilateral or bilateral uveitis being conducted at 27 study centers (26 centers in the U.S. and 1 in Singapore). The study protocol was approved by an institutional review board/ethics committee at each study site.

Study Drug

The study was carried out using a linear release (i.e., a constant release rate without plateau) FA intravitreal implant, which was inserted through a pars plana incision. The drug FA is a

Results

Patient recruitment began in November 2000 and concluded in August 2002. Patient demographics are summarized in Table 1. A total of 278 patients were randomized to receive either the 0.59-mg (n = 110) or the 2.1-mg (n = 168) FA implant. There were no significant differences in baseline characteristics between treatment groups. Mean age was 43.5 years (range, 7–84), and 72.3% of patients were female. The mean duration of uveitis before implantation was approximately 7 years.

Discussion

In the present study, the FA implant effectively controlled intraocular inflammation over the 34-week follow-up period, as demonstrated by a significant reduction in the uveitis recurrence rate and decreased need for adjunctive therapy. Furthermore, VA stabilized or improved, generally due to reductions in CME, when compared with the nonimplanted fellow eyes. The efficacy of the 0.59-mg implant did not differ from that of the 2.1-mg implant, suggesting that even with the lower-dose implant,

References (20)

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    Intravitreal corticosteroids may be applied as injections (often used in more severe cases of cystoid macular edema or vitritis47) or sustained-release implants. The latter allow for the reduction of the frequency of intravitreal injections, and current formulations release dexamethasone (Ozurdex®)21 or fluocinolone acetonide (Retisert®, Yutiq,® and Iluvien®).14,26,27 These regional dosage forms are not without limitations as they may lead to complications, most frequently intraocular pressure (IOP) elevation or cataract progression.4,47

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Manuscript no. 2005-788.

Dr Pearson has a financial interest in Control Delivery Systems, has received consulting fees from Bausch & Lomb, and is listed on patents concerning this technology. Drs Martin and Callanan have received consulting fees from Bausch & Lomb, and Dr Jaffe has received research support from Control Delivery Systems and Bausch & Lomb. Drs Levy and Comstock are employees of Bausch & Lomb.

Study Group investigators listed in “Appendix.”

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