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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Macular Edema

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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 (Spectralis; Heidelberg Engineering, Heidelberg, Germany). The randomization schedule was computer generated and stored in a locked cabinet until the study ended. Both patients and the study personnel who collected BCVA, OCT data were masked to the patient study assignment.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0,01ml dexamethasone solution<br>One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml. | Drug: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml<br>* 0,01 ml intravitreous dexamethasone solution 4mg/ml injection.<br>* Other names: 0,01 ml intravitreous dexamethasone solution;|
| Experimental: 0,03 ml dexamethasone solution<br>One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml. | Drug: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml<br>* 0,03 ml intravitreous dexamethasone solution 4mg/ml injection.<br>* Other names: 0,03 ml intravitreous dexamethasone solution;|
| Experimental: 0,05 ml dexamethasone solution<br>One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml. | Drug: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml<br>* 0,05 ml intravitreous dexamethasone solution 4mg/ml injection.<br>* Other names: 0,05 ml intravitreous dexamethasone solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular Thickness at 3 Days After Intravitreous Dexamethasone | Measure macular thickness at 3 days after intravitreous dexamethasone with OCT - unit µm | Three days after intravitreous dexamethasone | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic macular edema, Intravitreal dexamethasone solution, Short term treament