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Brian Savoie, Jonathan Jonisch; Efficacy and safety of dexamethasone intravitreal implant for diabetic macula edema in clinical practice: real-world results. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3263. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
While the efficacy and safety of the dexamethasone 0.7mg intravitreal implant (Ozurdex; Allergan, Inc., Irvine, C; henceforth DEX) in patients with diabetic macular edema (DME) has been demonstrated in clinical trials, little has been published regarding its use in clinical practice. We describe our results.
Retrospective case series of patients with DME treated with DEX over 15 months. Records were reviewed for demographics, prior treatment, logMAR best-corrected visual acuity (BCVA), central retinal thickness (CRT), intraocular pressure (IOP), cataract progression, adverse events and concurrent treatments. Patients were monitored at intervals determined by the treating physician. Patients with less than 30 days follow up were excluded. Descriptive statistics were recorded and significance was calculated using Student’s t-test.
36 patients with 43 eyes were identified, 35 patients with 41 eyes were included and one was excluded. Average patient age at presentation was 67.4 years (range 54-89), 18 were male and 17 were female. Average duration of follow up was 6.7 ± 3.5 months. Five eyes were treatment naïve, the remainder received one or more of the following: intravitreal anti-vascular endothelial growth factor agents, intravitreal triamcinolone, or focal laser. Mean BCVA at baseline was 0.72 ± 0.37 logMAR. Mean CRT at baseline was 537 ± 154um. After 6 months mean peak BCVA improved to 0.53 ± 0.33 logMAR (p<.05) and mean peak CRT improved to 348 ± 112um (p<.05). BCVA improved by three lines or more in 12 (29%) eyes. Increased IOP was observed in nine eyes (21%) and of 14 phakic eyes cataract progression was observed in one (7%).
Statistically significant improvement in BCVA (p<0.05) and CRT (p<0.05) over baseline was observed. Our rate of cataract progression (7%) was less then the Ozurdex MEAD study group (67.9%) while our rate of increased IOP (21%) was comparable to the Ozurdex MEAD study group (32%). Our rate of cataract progression likely reflects small sample size and inadequate long-term follow up data. Of patients with increased IOP, three were known steroid responders, two were being maintained on topical therapy and required no treatment, and one was being monitored off therapy and required maximal medical treatment. The use of DEX in known steroid responders remains ill defined but suggests an area of further investigation.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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