effect of dexamethasone on reduction of macular thickness in diabetic patients, a randomized clinical trial

Conditions: Diabetic Macular Edema

Summary: purpose: to determine the impact of short-term 4mg/ml dexamethasone solution treatment in diabetic macular edema (dme). design: phase ii, randomized, prospective, parallel, interventional study. participants: pseudophakic patients with central-involved dme. methods: twenty-seven patients with visual impairment caused by dme were randomized in a 1:1:1 ratio, in order to investigate treatment with 0.01 ml, 0.03 ml and 0.05 ml intravitreous dexamethasone solutions, and followed-up over 28 days outcome measures: the primary outcome was macular thickness at three days after intravitreous dexamethasone. the secondary outcomes were macular thickness at 28 days after intravitreous dexamethasone, best-corrected visual acuity (bcva) and intraocular pressure (iop) at three and 28 days after intravitreous dexamethasone

this is a prospective, phase ii, randomized, interventional, monocentric study. data of consecutive patients with dme who volunteered to participate in the research at the department of ophthalmology of state university of campinas (unicamp) - brazil between may 2016 and december 2017 were analysed. at the screening visit, all patients underwent complete ophthalmic evaluation, including best corrected visual acuity (bcva), slit-lamp biomicroscopy, applanation tonometry, fundus biomicroscopy, fluorescein angiography (visucam nm/ fa carl zeiss; carl zeiss meditec, california, usa), sd- oct (spectralis; heidelberg engineering, heidelberg, germany). central macular thickness was obtained through 7 horizontal lines ( 30° x 5° area), centered on the fovea, with 1536 a scans per line at 240 µm intervals. at the baseline study visit, patients were randomized with a 1:1:1 allocation to receive dexamethasone solution 4 mg/ml: 0,01 ml (40 µg) ; or 0,03 ml (120 µg); or 0,05 ml (200 µg). in follow up visits (1, 3, 7, 14, 21, 28 days after) were performed bcva, slit-lamp biomicroscopy, applanation tonometry, fundus biomicroscopy, sd- oct.

Eligibility criteria:
inclusion criteria: * age \> = 18 years; * diagnosis of dm type 2; * pseudophakic patients * presence of clinically significant dme according to etdrs guidelines; * best correct visual acuity (bcva) between 20/400 and 20/40; * central macular thickness (cmt) \>= 300 µm measured by spectral domain optical coherence tomography ( spectralis® heidelberg). if both eyes of the patient met the elegibility criteria, the eye with worse bcva at baseline was designated as the study eye. exclusion criteria: * any treatment of dme in the previous 4 months; * pan retinal photocoagulation (prp) in the previous 4 months or antecipated need of prp for the next 6 months; * any ophthalmologic surgery performed in the previous 4 months; * history of pars plana vitrectomy; * history of open-angle glaucoma or intraocular pressure elevation induced by corticosteroids that required anti-glaucomatous treatment or anti- hypertensive ocular treatment; * intraocular pressure \>= 21 mmhg; * patients with characteristics that meet the inclusion criteria, but refused to sign the written general consent.

Keywords: diabetic macular edema intravitreal dexamethasone solution short term treament