Long-term benefit of sustained-delivery XXXX vitreous inserts for @entity1103 .

@entity1 @entity231 @entity6 @entity20773 @entity726 @entity1103
OBJECTIVE: To assess the efficacy and safety of intravitreal inserts releasing 0.2  g/day (low dose) or 0.5  g/day (high dose) @entity20773 (FA) in @entity1 with @entity1103 ( @entity1103 ). DESIGN: Two parallel, prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trials. @entity1 : Subjects with persistent @entity1103 despite at least 1 macular laser treatment were randomized 1:2:2 to sham injection (n = 185), low-dose insert (n = 375), or high-dose insert (n = 393). METHODS: Subjects received study drug or sham injection at baseline and after 6 weeks were eligible for rescue laser. Based on retreatment criteria, additional study drug or sham injections could be given after 1 year. MAIN OUTCOME MEASURES: The primary outcome was the percentage of @entity1 with improvement from baseline best-corrected visual acuity (BCVA) in Early Treatment @entity6 Trial (ETDRS) letter score of 15 or more at month 24. Secondary outcomes included other parameters of visual function and foveal thickness (FTH). RESULTS: The percentage of @entity1 with improvement from baseline ETDRS letter score of 15 or more at month 24 was 28.7 and 28.6 in the low- and high-dose insert groups, respectively, compared with 16.2 in the sham group (P = 0.002 for each). Benefit occurred for both doses compared with sham at 3 weeks and all subsequent time points. The mean improvement in BCVA letter score between baseline and month 24 was 4.4 and 5.4 in the low- and high-dose groups, respectively, compared with 1.7 in the sham group (P = 0.02 and P = 0.016). At all time points compared with sham, there was significantly more improvement in FTH. Subjects requiring @entity231 surgery were more frequent in the insert groups, and their visual benefit was similar to that of subjects who were pseudophakic at baseline. @entity726 requiring incisional surgery occurred in 3.7%, 7.6%, and 0.5% of the low-dose, high-dose, and sham groups, respectively. CONCLUSIONS: Both low- and high-dose FA inserts significantly improved BCVA in @entity1 with @entity1103 over 2 years, and the risk-to-benefit ratio was superior for the low-dose insert. This is the first pharmacologic treatment that can be administered by an outpatient injection to provide substantial benefit in @entity1 with @entity1103 for at least 2 years.
