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SILVIO DI MONACO, Simona Berteramo, Nicola Delle Noci, Cristiana Iaculli; Prospective study to evaluate the safety of Dexamethasone Intravitreal Implant in Diabetic Macular Edema.. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3244.
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© ARVO (1962-2015); The Authors (2016-present)
Elevated intraocular pressure (IOP) is a well-known possible adverse event associated with steroid treatments, such as dexamethasone intravitreal implant (DEX-I). We performed a prospective study to evaluate the safety of DEX-I (0.7 mg, Ozurdex®, Allergan) in the treatment for persistant diabetic macular edema (DME).
We included a total of 32 eyes of 24 patients with persistant DME. Inclusion criteria: patients ≥18 years, with diagnosis of type 2 diabetes, DME resistant to previous treatments, BCVA (ETDRS) in the study eye between 34 and 79 letters, CRT (SD-OCT) ≥300 mm. Data were pooled for analysis in order to obtain median values and standard deviations. Exclusion criteria: uncontrolled diabetes (HbA1c >10%), blood pressure >160/100 mmHg, treatment with intravitreal anti-VEGF within 3 months of study entry, treatment with intravitreal triamcinolone within 6 months of study entry, current use or anticipated use of systemic steroids during the study, uncontrolled glaucoma with maximal topical treatment and ocular hypertension in the study eye characterized by IOP>23 mmHg without antiglaucoma medication. Patients with aphakia or an anterior chamber intraocular lens in the study eye, a history of intraocular laser or incisional surgery in the study eye within 90 days before study entry, or active iris or retinal neovascularization in the study eye were excluded. The outcome measures evaluated were IOP and cataract progression at baseline, 1 day, 1 week and monthly until 6 months after the administration of DEX-I.
Between the first and the third month, 3 eyes (9,4%) had an IOP rise ≥10 mmHg from baseline and only 2 eyes (6,2%) had an IOP≥25 mmHg. No patients showed IOP≥35 mmHg. The observed increase of IOP was managed by topical treatment. At 6 months, no ocular hypertension was observed. We didn’t register any increase in lens opacities at 6 months.
A slight, but statistically significant, increase in the mean IOP was observed from first through the third month perfectly manageable in our practice. The maximum increase was at the second month, with a mean of 15.84 mmHg for all the treated eyes, respect to the mean at the baseline, which was 13.44 mmHg (p=0.0015). No increase in lens opacities was registered during follow-up. The safety profile of DEX-I was acceptable as shown in previous studies.
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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