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R.S. Ramchandran, S.S. Stinett, G.J. Jaffe; Fluocinolone Acetonide Sustained Drug Delivery Device for Chronic Retinal Venous Occlusive Disease . Invest. Ophthalmol. Vis. Sci. 2006;47(13):5907.
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Macular edema associated with retinal venous occlusive disease may be chronic and cause severe vision loss. We hypothesized that long–acting intravitreal corticosteroid therapy with fluocinolone acetonide would decrease macular edema and improve visual acuity in these eyes. Herein we determined the efficacy and safety of a fluocinolone acetonide sustained drug delivery implant in eyes with longstanding macular edema associated with CRVO or BRVO.
A 3–year fluocinolone acetonide sustained drug delivery system was implanted into 19 eyes of 19 patients with chronic macular edema associated with BRVO (3 eyes) or CRVO (16 eyes). Visual acuity (Va), intraocular pressure (IOP), central foveal thickness (CFT) determined by OCT were recorded during the first 12 months following fluocinolone acetonide implantation.
The median vein occlusion duration was 13 months (6–49 months). Before implantation, all eyes but one had previous therapy. No eye had any intraoperative complications. At 2 months there was a significant improvement in visual acuity (p=0.0013); the median pre–operative LogMAR Va was 0.80 (snellen equivalent 20/126). The median postoperative Va was 0.60 LogMAR units (snellen equivalent 20/80), which was maintained at post–operative month 12. The following postoperative results refer to data obtained 12 months post–device implantation: The number of lines gained after receiving the implant was significant (p=0.046). Va was > 2 lines better in 11 eyes, was unchanged in 2 eyes, and was >2 lines worse in 3 eyes. The median central retinal thickness decreased significantly (547 mm preoperatively vs 199 µm postoperatively; p=0.001). The mean preoperative IOP, 14.2 mm Hg, did not differ significantly from the postoperative IOP, 17.1 mm Hg. On average, at baseline and 12 months, eyes required 0.2, and 1 anti–ocular hypertensive medications respectively to lower IOP. At post–operative month 2, 10 patients (p=0.01), required topical IOP lowering medication. By post–operative month 12, 7 eyes required filtration surgery (p=0.01). 1 eye developed postoperative endophthalmitis.
The fluocinolone acetonide sustained drug delivery implant effectively reduces macular edema, and improves visual acuity in a significant proportion of eyes with longstanding macular edema associated with vein occlusion, not responsive to alternative therapy. IOP must be carefully monitored. This system is a promising novel alternative to currently available treatments for this challenging patient population.
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