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P. Mruthyunjaya, D. Khalatbari, P. Yang, S. Stinnett, M. Hanes, G.J. Jaffe; An Intravitreal Sustained-Release Fluocinolone Acetonide Device to Treat Severe Experimental Uveitis . Invest. Ophthalmol. Vis. Sci. 2003;44(13):4215.
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Purpose: An intravitreal sustained release fluocinolone acetonide (sr-FA) device has been shown in human subjects to control inflammation in eyes with chronic posterior uveitis and panuveitis. To minimize side effects, devices with the lowest possible effective release-rates are needed. In this study, we determined the efficacy of low release-rate (0.5 µg/day, batch no. RD066, and 0.1 µg/day, batch no. RD065) intravitreal sr-FA devices to inhibit ocular inflammation in a rabbit model of severe uveitis. Methods: A sr-FA device with a release rate of either 0.5 µg/day (n=16) or 0.1 µg/day (n=16) was implanted into the vitreous of the right eye of NZW rabbits fourteen days after a subcutaneous injection of tuberculin antigen. Control animals (n=14) received empty devices. Uveitis was induced with an intravitreal tuberculin antigen injection. A masked observer graded corneal neovascularization, anterior chamber (AC) flare, cell, iris congestion, and vitreous opacity on days 1-7, 9, 16, and 21 after uveitis induction. Animals were sacrificed on days 6 and 9 for aqueous WBC count and protein measurement. Retinal function was evaluated by ERG. Histologic sections of enucleated eyes were studied under light microscopy. Results: By clinical criteria, treated eyes were significantly less inflamed than untreated eyes. Anterior chamber cell, flare and vitreous opacity were significantly reduced (p≤0.02) in both drug implant groups compared with control animals. Overall, inflammation was suppressed to a greater degree with the 0.5 µg/day device compared to the 0.1 µg/day device. Aqueous WBC count, protein concentration, ERG b-wave amplitudes, and histopathologic examination paralleled this clinical assessment. Conclusions: Intravitreal sustained-release fluocinolone devices suppress ocular inflammation in a rabbit model of severe uveitis. A low release-rate device may help to reduce potential side effects such as glaucoma and cataract. The inhibition of inflammation demonstrated with the 0.1 µg/day implant provides the rationale for future human studies with lower release-rate devices than are currently employed in clinical trials. Word count of abstract = 2431
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