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Sunil K. Srivastava, Thomas A. Albini, David Callanan, Debra A. Goldstein, James Bena, Quan D. Nguyen; Outcomes Of Patients Treated With The Fluoconinole Acetonide Implant And Standard Of Care Therapy For Non-infectious Uveitis: Combined Results Of Three Clinical Trials. Invest. Ophthalmol. Vis. Sci. 2012;53(14):2250.
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To report outcomes of patients treated with the fluocinolone acetonide implant (Retisert) and standard of care therapy from the pooled data of three clinical trials examining the use of the implant in non-infectious uveitis. Subgroup analysis was performed to examine the outcomes in specific groups of uveitic patients.
Data from the three fluocinolone acetonide trials (415-001,002,004) were obtained and combined into a master data sheet. Outcome measures including logMar ETDRS vision, time to recurrence, number of recurrences and fluorescein leakage were evaluated at baseline, 12 months and 24 months. Three distinct groups were analyzed - implant eyes (IMP), fellow eyes of implanted eye (FEL) and eyes treated with standard of care (SOC)
A total of 1170 eyes were included in analysis, 577 eyes treated with the implant (IMP), 450 fellow (FEL) eyes and 133 standard of care (SOC) eyes. IMP eyes had worse vision at baseline (.54) in comparison to FEL (.40) and SOC (.3). At 24 months, IMP eyes improved to .45 while FEL eyes worsened to .46 and SOC eyes stayed about the same (.3) (p<.01). At 24 months, 30% of IMP eyes improved 3 lines or better in comparison to 15% of FEL eyes and 10% of SOC eyes (p<.0001). 12% of IMP eyes lost 2 lines or more vs 20% of FEL eyes and 23% of SOC eyes. At baseline, fluorescein grading revealed 70% of IMP eyes had either petalloid, or diffuse macular leakage vs 48% of FEL eyes and 58% of SOC eyes. By 24 months, 73% of IMP eyes with baseline leakage had resolution of leakage vs 26% of FEL eyes and 28% of SOC eyes (p<.0001). The measured area of leakage also significantly decreased in IMP eyes while remaining the same in both the FEL and SOC eyes. Those eyes with resolution of macular leakage were more likely to have vision improvement. When examining specific subgroups, IMP eyes diagnosed with birdshot choroidopathy were more likely to have significant visual improvement than FEL or SOC eyes. IMP eyes of pediatric patients also had superior vision and visual improvement at 24 months in comparison to FEL eyes.
In this analysis of the pooled data from the three fluocinolone acetonide implant studies, IMP eyes were more likely to have significant vision improvement vs SOC and FEL eyes. IMP eyes on average improved 1 line over 24 months vs FEL and SOC eyes which either remained the same or slightly worsened. IMP eyes were also more likely to have improvement in fluorescein leakage than FEL and SOC eyes at 24 months. Subgroups analysis revealed eyes with a diagnosis of birdshot choroidopathy had more visual improvement with an IMP vs SOC and FEL.
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