Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial

Phase 2

Completed

Interventions: Drug: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml
Drug: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml
Drug: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml

Brief 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

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
0,01ml dexamethasone solution	Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml	One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.
0,05 ml dexamethasone solution	Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml	One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.
0,03 ml dexamethasone solution	Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml	One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.

Primary Outcome Measures

Name	Time	Method
Macular Thickness at 3 Days After Intravitreous Dexamethasone	Three days after intravitreous dexamethasone	Measure macular thickness at 3 days after intravitreous dexamethasone with OCT - unit µm

Secondary Outcome Measures

Name	Time	Method
Macular Thickness at 28 Days After Intravitreous Dexamethasone	28 days after intravitreous dexamethasone	Measure macular thickness at 28 days after intravitreous dexamethasone with OCT - unit µm
Best Corrected Visual Acuity (BCVA) at 3 Days After Intravitreous Dexamethasone	Three days after intravitreous dexamethasone	Measure best corrected visual acuity (BCVA) at 3 days after intravitreous dexamethasone with ETDRS chart
Best Corrected Visual Acuity (BCVA) at 28 Days After Intravitreous Dexamethasone	28 days after intravitreous dexamethasone	Measure best corrected visual acuity (BCVA) at 28 days after intravitreous dexamethasone with ETDRS chart
Intraocular Pressure (IOP) at 3 Days After Intravitreous Dexamethasone	3 days after intravitreous dexamethasone	Measure intraocular pressure (IOP) 3 days after intravitreous dexamethasone - unit mmHg
Intraocular Pressure (IOP) at 28 Days After Intravitreous Dexamethasone	28 days after intravitreous dexamethasone	Measure intraocular pressure (IOP) 28 days intravitreous dexamethasone - unit mmHg