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

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.

Fig. 1

Kaplan–Meier time to uveitis recurrence for implanted study eyes versus nonimplanted fellow eyes in the 0.59- and 2.1-mg implant group. Discontinued patients were censored following their last visit. P < 0.001 for the within-treatment difference comparison of study eye versus fellow eye; P = 0.0062 for the between-treatment difference in implanted eyes

Fig. 2

Change in best-corrected visual acuity from baseline up to 3 years post-implantation in the 0.59- and 2.1-mg implant groups. A negative value represents an improvement (P values from paired t test). *P < 0.0001. ^† P = 0.0007. logMAR logarithm of the minimum angle resolution, VA visual acuity

Fig. 3

Proportion of eyes with an improvement (left panel) or deterioration (right panel) in visual acuity from baseline of at least 0.30 logMAR at 3 years in the 0.59- and 2.1-mg implant groups. (P values for the within-treatment comparison of study eye versus fellow eye). *P < 0.0001. ^† P = 0.0046. logMAR logarithm of the minimum angle resolution