http://www.evrs.eu/medias/2006/congress/Three-year-Results-of-a-Multi-center-Clinical-Trial-of-Fluocinolone-Acetonide-Intravitreal-Implants-to-Treat-Posterior-Uveitis.swf

Daniel F. Martin, MD (Atlanta, GA),* David G. Callanan, MD (Arlington, TX),* Glenn J. Jaffe, MD (Durham, NC),* Brian Levy, OD, MS (Rochester, NY),* Timothy Comstock, OD, MS (Rochester, NY)*

PURPOSE:

A 3-year prospective, multi-center, dose-masked randomized clinical trial was performed to determine the safety and efficacy of a sustained-release fluocinolone acetonide intravitreal implant (Retisert) for the treatment of patients with chronic non-infectious recurrent posterior segment uveitis.

METHODS:

A total of 278 eligible patients with chronic non-infectious recurrent posterior segment uveitis were treated with 0.59 mg or 2.1 mg fluocinolone acetonide intravitreal implants in their more severely diseased eye. Primary outcomes measured included change in the rate of recurrence, change in visual acuity, the need for adjunctive therapy, and adverse events.

RESULTS:

The aggregate rate of recurrence for implanted eyes was 33% at 3 years post-implant, compared to 5% and 14% at 1 and 2 years, respectively. The recurrence rate for nonimplanted eyes was 57% over the same 3 year period (P<0.001). At 3 years, 20% of eyes that received implants demonstrated an improvement of 3 or more lines from baseline visual acuity compared to 5% of non-implanted eyes. The most common serious adverse events were cataract extraction, filtering procedures, and explantation for control of IOP. By 3 years, nearly all implanted eyes that were phakic at baseline had undergone cataract extraction (93%) and 40% of all study eyes had had filtering procedures. Explantation was required to control intraocular pressure in 2% of patients.

CONCLUSION:

At 3 years, fluocinolone implant treated eyes had a reduced rate of recurrence of inflammation as compared to control eyes. However, the rate was higher than at years 1 and 2 suggesting that additional treatment, including possible implant replacement, may be necessary between the 24M and 36M time points in some patients. Intraocular pressure and lens clarity must be closely monitored.
* Financial interest disclosed