Article Date: 1/1/2008

Retisert Reimplantation Appears Safe and Effective
PRESENTATIONS FROM THE RETINA SOCIETY

Retisert Reimplantation Appears Safe and Effective

Similar control of inflammation seen, as from first procedure.

A team of retinal physicians from the Cole Eye Institute at the Cleveland Clinic provided a presentation at the Retina Society meeting in Boston in September on the outcome of reimplantation of a fluocinolone acetonide implant (Retisert, Bausch & Lomb, Rochester, NY) in patients with chronic noninfectious posterior uveitis. Mehran Taban, MD, who gave the presentation, along with Careen Y. Lowder, MD, PhD, and Peter K. Kaiser, MD, concluded that there was little difference between initial and second implantation of the fluocinolone acetonide device.

METHODOLOGY AND EXPECTATIONS

Dr. Taban began by describing the methods he and his coinvestigators undertook in this study. They conducted a retrospective, observational case series over the period from 2001 to 2006. Included were patients with recurrent noninfectious posterior uveitis who had undergone second fluocinolone implant in the same eye after the initial implant had been depleted. Patients who had posterior uveitis not accompanied by vitritis or macular edema were excluded from the study. A total of 10 eyes from 10 patients were studied, all of which had also been part of the 3-year multi-center study for primary fluocinolone implantation.

The primary outcome measure used by Drs. Taban, Lowder, and Kaiser was the recurrence rate of noninfectious posterior uveitis, both before and after the first and second implantations. (The criteria used were the same as the above-mentioned 3-year study.) The comparison period before the first implant was 34 weeks, which was what was performed for the multicenter study. Surgical complications, stability of visual acuity (VA; considered stable if ≤1 line of vision was lost relative to VA at the time of implantation), need for adjunctive therapy (topic, periocular, or systemic), complications and side effects, and general safety were also considered.

Mehren Taban, MD, Careen Y. Lowder, MD, PhD, and Peter K. Kaiser, MD, are all retinal physicians at the Cole Eye Institute of the Cleveland Clinic. Dr. Kaiser has served on the advisory board for Bausch & Lomb. Drs. Taban and Lowder have no financial interests to report.

The mean duration of uveitis before the first fluocinolone implantation was 55.5 months, with a range of 20 to 104 months. In the 34-week preimplantation period, there was recurrence of uveitis in all 10 implanted eyes vs 67% of the fellow eyes. After the first fluocinolone implant was placed, the median time to first recurrence was 32.5 months in implanted eyes and 2 months in fellow eyes.

Following the second implantation, performed at a median of 45 months following the first implant, the median time to recurrence was 18.3 months in 4 of the implanted eyes and 6.7 months in 3 fellow eyes; 6 implanted eyes did not have recurrence. Vision results were remarkable in that 100% of implanted eyes had stabilized or improved VA.

SAFETY AND SIDE EFFECTS

In terms of safety considerations and side effects, cataract and intraocular pressure (IOP) were observed. Cataract extraction was required in all the phakic eyes (n=4) following the first implant. Five eyes had required surgery due to elevated IOP during the efficacy period of their first implant. One eye's IOP was managed with topical drops, but the same eye later required an Ahmed valve 8.5 months after the second fluocinolone device was inserted. None of the fellow eyes required surgery due to elevated IOP.

Other complications observed were 1 case of vitreous hemorrhage after the first implantation — a hemorrhage that resolved on its own — and 1 case of vitreous bands after the first implantation that required vitrectomy a year later.

Finally, the team concluded that fluocinolone reimplantation "offers relatively similar control of inflammation" and a similar complications profile, while conceding that more data are needed before more decisive conclusions can be made. RP



Retinal Physician, Issue: January 2008