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J. I. Lim, M. R. Wieland, A. Fung, D. Y. Hung, V. Wong; A Phase 1 Study Evaluating the Safety and Evidence of Efficacy of IBI-20089, A Triamcinolone Intravitreal Injection Formulated With the VerisomeTM Drug Delivery Technology, in Patients With Cystoid Macular Edema. Invest. Ophthalmol. Vis. Sci. 2009;50(13):5395.
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VerisomeTM drug delivery technology is a versatile system for controlling the release of therapeutic agents such as small molecules, peptides, proteins and monoclonal antibodies into the eye for extended delivery periods. Prior work in rabbits showed a single intravitreal injection of IBI-20089, formulated with the VerisomeTM technology, delivers triamcinolone acetonide (TA) at a mean daily dose of 1.1 ug/ml for up to one year. The purpose of this clinical study is to investigate the safety and preliminary evidence of efficacy of IBI-20089 in patients with cystoid macular edema (CME).
Patients with chronic CME resulting from retinal vein occlusion were given one of two doses of an intravitreal injection of IBI-20089 using standard techniques via a 28 or 30 gauge needle. An open label, sequential cohort (five patients each) dosing scheme was used. The first cohort received 6.9 mg/ 25 ul TA; the second cohort received 13.8 mg / 50 ul TA. 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.
10 patients, aged 55 to 88 years old, with CME secondary to venous occlusive disease were enrolled. In both cohorts the majority of patients had reduced macular thicknesses within one day of treatment and remained lower than baseline at 120 days (Table 1). For the 6.9 mg cohort, mean central subfield OCT thickness decreased from a baseline value of 499µ to 368.6µ at day 1 (p< 0.06); 386.8µ at day 30 (p= 0.186) and 349.8µ at day 120 (p=0.133). For the 13.8 mg cohort, mean central subfield OCT thickness decreased from a baseline value of 518.2µ to 404µ at day 1 (p=0.134), 289µ at day 30 (p=0.003) and 225.4µ at day 120 (p=0.009). The delivery system visibly shrunk as the drug was released. There was one serious adverse related event in the 13.8 mg cohort; this patient underwent a successful Ahmed shunt procedure for elevated intraocular pressure.
IBI-20089 appears to be safe and well tolerated with evidence of controlled release efficacy for CME. The 13.8 mg cohort showed more evidence of efficacy than the 6.9 mg cohort.
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