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J. I. Lim, D. Hung, A. E. Fung, M. Wieland, V. Wong; One Year Results of a Phase 1 Study Evaluating the Safety and Evidence of Efficacy of a Single Intravitreal Injection of the VerisomeTM Liquid Drug Delivery System for Sustained Release of Low-Dose Triamcinolone (IBI-20089) in Eyes With Cystoid Macular Edema. Invest. Ophthalmol. Vis. Sci. 2010;51(13):6396.
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The VerisomeTM is an injectable, liquid, intravitreal, sustained release drug delivery system. A single injection of the Verisome formulated with triamcinolone (TA), IBI-20089, delivers a mean daily dose of 1.1 ug/ml TA for up to one year in rabbits. The purpose of this clinical study is to investigate the safety and evidence of efficacy of IBI-20089 in cystoid macular edema (CME) patients at one year.
Patients with chronic CME resulting from retinal vein occlusion received one of two doses of an intravitreal injection of IBI-20089. An open label, sequential cohort (five patients each) dosing scheme was used. Each patient received one IBI-20089 injection: either 6.9 mg (25 ul) TA (cohort 1) or13.8 mg (50 ul) TA (cohort 2). Patients were followed at 1 day, 1 week, 1 month, 2 months, 4 months, 6 months, 9 months and 12 months. Informed consent was obtained prior to entry into the study. Clinical examination, OCT imaging, physical examination and laboratory testing were performed at each visit.
10 patients, aged 55 to 88 years old, with CME secondary to venous occlusive disease were enrolled. For the 6.9 mg cohort, mean central subfield OCT thickness decreased from a baseline value of 499µ to 387 u at 30 days (p=0.19), 386 u at 60 days (p=0.18), 350 u at 120 days (p=0.13), 301 u at 180 days (p=0.18), 244 u at 270 days (p=0.47), and 251 u at 360 days (p=0.46). For the 13.8 mg cohort, mean central subfield OCT thickness decreased from a baseline value of 518µ to 320 u at day 7 (p=0.03), 289 u at day 30 (p=0.003), 234 u at day 60 (p=0.003), 225 u at day 120 (p=0.01), 207 u at day 180 (p=0.004), 276 u at day 270 (p=0.001) and 278 u at day 360 (p=0.009). The delivery system visibly shrunk as the drug was released. There were two adverse related events in the 13.8 mg cohort. Both were CRVO patients that developed NVI and elevated IOPs. One patient underwent a successful Ahmed shunt procedure and the other responded to PRP alone.
IBI-20089 was well tolerated with evidence of controlled release efficacy for CME. The higher dose cohort showed significant reductions in retinal thickness as compared to the lower dose cohort.
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