TY - JOUR
T1 - Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema
AU - Campochiaro, Peter A.
AU - Brown, David M.
AU - Pearson, Andrew
AU - Ciulla, Thomas
AU - Boyer, David
AU - Holz, Frank G.
AU - Tolentino, Michael
AU - Gupta, Amod
AU - Duarte, Lilianne
AU - Madreperla, Steven
AU - Gonder, John
AU - Kapik, Barry
AU - Billman, Kathleen
AU - Kane, Frances E.
N1 - Funding Information:
Supported by Alimera Sciences, Inc. , Atlanta, Georgia, and Psivida, Inc. , Watertown, Massachusetts. Original article
PY - 2011/4
Y1 - 2011/4
N2 - Objective: To assess the efficacy and safety of intravitreal inserts releasing 0.2 μg/day (low dose) or 0.5 μg/day (high dose) fluocinolone acetonide (FA) in patients with diabetic macular edema (DME). Design: Two parallel, prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trials. Participants: Subjects with persistent DME 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 patients with improvement from baseline best-corrected visual acuity (BCVA) in Early Treatment Diabetic Retinopathy 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 patients 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 cataract surgery were more frequent in the insert groups, and their visual benefit was similar to that of subjects who were pseudophakic at baseline. Glaucoma 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 patients with DME 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 patients with DME for at least 2 years. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.
AB - Objective: To assess the efficacy and safety of intravitreal inserts releasing 0.2 μg/day (low dose) or 0.5 μg/day (high dose) fluocinolone acetonide (FA) in patients with diabetic macular edema (DME). Design: Two parallel, prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trials. Participants: Subjects with persistent DME 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 patients with improvement from baseline best-corrected visual acuity (BCVA) in Early Treatment Diabetic Retinopathy 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 patients 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 cataract surgery were more frequent in the insert groups, and their visual benefit was similar to that of subjects who were pseudophakic at baseline. Glaucoma 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 patients with DME 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 patients with DME for at least 2 years. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.
UR - http://www.scopus.com/inward/record.url?scp=79953329178&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79953329178&partnerID=8YFLogxK
U2 - 10.1016/j.ophtha.2010.12.028
DO - 10.1016/j.ophtha.2010.12.028
M3 - Article
C2 - 21459216
AN - SCOPUS:79953329178
SN - 0161-6420
VL - 118
SP - 626-635.e2
JO - Ophthalmology
JF - Ophthalmology
IS - 4
ER -