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Beatriz Jiménez Gómez, Alex Fonollosa, Joseba Artaraz, Ana Orive, Sonia Valsero, Maria Elena Gonzalez-Montpetit, Jose A Sanchez; Effects of Ozurdex on intraocular pressure: a real- life clinical practice study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1781.
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The Dexamethasone biodegradable implant Ozurdex is approved by the US Food and Drug Administration and by the European Medical Agency for the treatment of intermediate and posterior uveitis and for the treatment of macular edema following retinal vein occlusion. Use as off label drug for treating diabetic macular edema has been reported, showing promising results. The pivotal clinical trials HURON and GENEVA showed a low rate of ocular hypertension after Ozurdex treatment. The aim of our study was to assess the effects on intraocular pressure in a cohort of patients from the real- life clinical practice.
Retrospective review of clinical records of patients treated with Ozurdex in Hospital Universitario Cruces in a 6 month period. The following variables were recorded: age, gender, diagnosis and history of glaucoma; intraocular pressure , antihypertensive treatment and macular thickness were recorded before injection and at 1st, 2nd, 4th and 6th months after the injection. Statistical tests: Mann-Whitney U test, Chi square test (with Fisher’s correction when needed) and Wilcoxon test. The level of statistical significance was set at p<0.05.
The effects of 75 injections given to 67 patients (35 women, 52%, mean age 62) was evaluated. The diagnosis were: 14 (18.7%): Central retinal Vein Occlusion, 25 (33.3%): Branch retinal Vein Occlusion, 12 (16%): diabetic macular edema and 24 (32%): Uveitis. Mean intraocular pressure before the injection was 15.9 mmHg and at 1st, 2nd, 4th and 6th months after the injection: 18.80 (p=0.627), 18.84 (p=0.494), 17.02 (p=0.796) and 15.5 (p=0.829). Regarding antihypertensive treatment, 30.7% were on drops before the injection and 37.3% at 6th month. (p=0.118). We did not observe statistically significant differences in intraocular pressure measurements at the mentioned follow up visits between patients with and without history of glaucoma. Mean macular thickness before injection was 483.46 microns; after injection, at 2nd month: 301 (p<0.001) and at 6 th month 373 (p=0.023).
In the real -life clinical practice, Ozurdex shows an excellent safety profile in terms of intraocular hypertension. Patients with history of glaucoma may also show this profile, being Ozurdex a good option to treat retinal diseases in these patients.
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