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1.  Sustained Release Intravitreal Liquid Drug Delivery Using Triamcinolone Acetonide for Cystoid Macular Edema in Retinal Vein Occlusion 
Ophthalmology  2011;118(7):1416-1422.
Purpose
To investigate side effects seen with this formulation and to search for evidence of effectiveness after a single intravitreal injection of IBI-20089 in eyes with cystoid macular edema (CME) secondary to retinal vein occlusion.
Design
Prospective phase 1 clinical trial
Participants
10 patients with chronic CME due to retinal vein occlusion
Methods
Patients received a single intravitreal injection of IBI-20089 using a sequential dose escalation schedule. Each cohort consisted of five patients who received the intravitreal injection of the sustained liquid drug delivery system containing either 6.9 mg (25 ul) triamcinolone acetonide (TA) (Cohort 1) or 13.8 mg (50 ul) TA (Cohort 2). At each study visit, best corrected visual acuity testing, slit lamp biomicroscopy, intraocular pressure (IOP) measurement, dilated ophthalmoscopy, fundus photography and optical coherence tomography (OCT) were performed. Patients also underwent laboratory testing and physical examinations to monitor for any systemic adverse events.
Main Outcome measures
OCT central subfield thickness, ocular and systemic adverse events
Results
In Cohort 1, mean baseline OCT central subfield thickness (CST) was 477 microns (μ) and decreased to 369 μ at day 1 (p< 0.06), 387 μ at day 30 (p= 0.18) and 251 μ at day 360 (p=0.46). In Cohort 2, mean baseline OCT CST was 518 μ, and decreased to 404 μ at day 1 (p=0.134), 289 μ at day 30 (p=0.003), 207 μ at day180 (p=0.004) and 278 μ at day 360 (p=0.009). Related adverse events included elevation of IOP in three patients; two due to neovascular glaucoma (not related to study drug) and one which required a glaucoma tube shunt.
Conclusion
A single intravitreal injection of IBI-20089 resulted in a controlled and sustained delivery of a TA. Side effects included elevated IOP in three eyes, two of which had neovascular glaucoma.
doi:10.1016/j.ophtha.2010.12.029
PMCID: PMC3735605  PMID: 21397950
2.  Hospitalized cardiovascular events in patients with diabetic macular edema 
BMC Ophthalmology  2012;12:11.
Background
Microvascular and macrovascular complications in diabetes stem from chronic hyperglycemia and are thought to have overlapping pathophysiology. The aim of this study was to investigate the incidence rate of hospitalized myocardial infarctions (MI) and cerebrovascular accidents (CVA) in patients with diabetic macular edema (DME) compared with diabetic patients without retinal diseases.
Methods
This was a retrospective cohort study of a commercially insured population in an administrative claims database. DME subjects (n = 3519) and diabetes controls without retinal disease (n = 10557) were matched by age and gender. Healthcare claims were analyzed for the study period from 1 January 2002 to 31 December 2005. Incidence and adjusted rate ratios of hospitalized MI and CVA events were then calculated.
Results
The adjusted rate ratio for MI was 2.50 (95% CI: 1.83-3.41, p < 0.001) for DME versus diabetes controls. Predictors of MI events were heart disease, history of acute MI, and prior use of antiplatelet or anticoagulant drugs. The adjusted rate ratio for CVA was 1.98 (95% CI: 1.39-2.83, p < 0.001) for DME versus diabetes controls. Predictors of CVA events were cardiac arrhythmia, Charlson comorbidity scores, history of CVA, hyperlipidemia, and other cerebrovascular diseases.
Conclusion
Event rates of MI or CVA were higher in patients with DME than in diabetes controls. This study is one of few with sufficient sample size to accurately estimate the relationship between DME and cardiovascular outcomes.
doi:10.1186/1471-2415-12-11
PMCID: PMC3395554  PMID: 22646811

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