FLUOCINOLONE ACETONIDE SUSTAINED DRUG DELIVERY IMPLANT TO TREAT SEVERE UVEITIS

Glenn Jaffe, B. Branchaud, K. Karloff, P. Ashton (Durham/Watertown)

Purpose: Uveitis is often a chronic disease requiring long-term medical therapy. In this report, we describe results of a pilot safety and efficacy trial of a novel sustained drug delivery system containing fluocinolone acetonide to treat patients with severe uveitis.

Methods: Sustained drug delivery devices designed to release fluocinolone acetonide for at least 2.5 years were implanted through the pars plana into the vitreous cavity of 15 eyes of 13 patients. All patients had severe uveitis that was not well controlled with, or were intolerant to, repeated periocular corticosteroid injections, systemic corticosteroids and/or immunosuppressive agents at the time of device implantation. Prior to device implantation, patients underwent complete evaluation including history, ophthalmologic examination, fluorescein angiography, visual field testing, optical coherence tomography, and electroretinography. Postoperatively, patients were re-examined at 1 week, 2 weeks, 4 weeks, and at 1 - 3 month intervals. The main outcome measures, collected prospectively, included visual acuity (ETDRS), ocular inflammation, anti-inflammatory medication use, and intraocular pressure.

Results: Patients were followed an average of 11 months (range five - 19 months). All eyes had stabilized or improved visual acuity after device implantation. The mean final visual acuity, 20/171 was significantly better than the preoperative visual acuity, 20/428 (p = 0.005). Postoperatively, at the final visit, no eye had clinically detectable inflammation, and all eyes had a marked reduction in systemic, topical, and/or periocular anti-inflammatory medication use. The preoperative intraocular pressure, 15 mm Hg, was not signicantly different from the final postoperative intraocular pressure (16 mm Hg). Five eyes developed increased intraocular pressure requiring therapy 6 weeks - 6 months following device implantation .

Conclusion: A fluocinolone acetonide sustained drug delivery device is a promising new therapy for the treatment of severe uveitis. It stabilizes vision, controls inflammation, and decreases the need for anti-inflammatory therapy. Intraocular pressure must be carefully monitored followed after device implantation.


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