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

Primary Purpose

Diabetic Macular Edema

Status

Completed

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml

Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml

Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic macular edema, Intravitreal dexamethasone solution, Short term treament

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

State University of Campinas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

0,01ml dexamethasone solution

0,03 ml dexamethasone solution

0,05 ml dexamethasone solution

Arm Description

One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.

One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.

One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.

Outcomes

Primary Outcome Measures

Macular Thickness at 3 Days After Intravitreous Dexamethasone

Measure macular thickness at 3 days after intravitreous dexamethasone with OCT - unit µm

Secondary Outcome Measures

Macular Thickness at 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

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

Measure best corrected visual acuity (BCVA) at 28 days after intravitreous dexamethasone with ETDRS chart

Intraocular Pressure (IOP) at 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

Measure intraocular pressure (IOP) 28 days intravitreous dexamethasone - unit mmHg

Full Information

NCT ID

NCT03608839

First Posted

July 12, 2018

Last Updated

October 5, 2019

Sponsor

Universidade Federal de Pernambuco

1. Study Identification

Unique Protocol Identification Number

NCT03608839

Brief Title

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

Acronym

EDRMT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

May 1, 2016 (Actual)

Primary Completion Date

December 20, 2017 (Actual)

Study Completion Date

October 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Federal de Pernambuco

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

Keywords

Diabetic macular edema, Intravitreal dexamethasone solution, Short term treament

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

All the patients were masked. They didn't have acess to the group they belonged. The care provider didn't know the quantity of the drug injected. The outcome assessor was masked as well.

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0,01ml dexamethasone solution

Arm Type

Experimental

Arm Description

One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.

Arm Title

0,03 ml dexamethasone solution

Arm Type

Experimental

Arm Description

One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.

Arm Title

0,05 ml dexamethasone solution

Arm Type

Experimental

Arm Description

One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.

Intervention Type

Drug

Intervention Name(s)

Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml

Other Intervention Name(s)

0,01 ml intravitreous dexamethasone solution

Intervention Description

0,01 ml intravitreous dexamethasone solution 4mg/ml injection.

Intervention Type

Drug

Intervention Name(s)

Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml

Other Intervention Name(s)

0,03 ml intravitreous dexamethasone solution

Intervention Description

0,03 ml intravitreous dexamethasone solution 4mg/ml injection.

Intervention Type

Drug

Intervention Name(s)

Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml

Other Intervention Name(s)

0,05 ml intravitreous dexamethasone solution

Intervention Description

0,05 ml intravitreous dexamethasone solution 4mg/ml injection.

Primary Outcome Measure Information:

Title

Macular Thickness at 3 Days After Intravitreous Dexamethasone

Description

Measure macular thickness at 3 days after intravitreous dexamethasone with OCT - unit µm

Time Frame

Three days after intravitreous dexamethasone

Secondary Outcome Measure Information:

Title

Macular Thickness at 28 Days After Intravitreous Dexamethasone

Description

Measure macular thickness at 28 days after intravitreous dexamethasone with OCT - unit µm

Time Frame

28 days after intravitreous dexamethasone

Title

Best Corrected Visual Acuity (BCVA) at 3 Days After Intravitreous Dexamethasone

Description

Measure best corrected visual acuity (BCVA) at 3 days after intravitreous dexamethasone with ETDRS chart

Time Frame

Three days after intravitreous dexamethasone

Title

Best Corrected Visual Acuity (BCVA) at 28 Days After Intravitreous Dexamethasone

Description

Measure best corrected visual acuity (BCVA) at 28 days after intravitreous dexamethasone with ETDRS chart

Time Frame

28 days after intravitreous dexamethasone

Title

Intraocular Pressure (IOP) at 3 Days After Intravitreous Dexamethasone

Description

Measure intraocular pressure (IOP) 3 days after intravitreous dexamethasone - unit mmHg

Time Frame

3 days after intravitreous dexamethasone

Title

Intraocular Pressure (IOP) at 28 Days After Intravitreous Dexamethasone

Description

Measure intraocular pressure (IOP) 28 days intravitreous dexamethasone - unit mmHg

Time Frame

28 days after intravitreous dexamethasone

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rodrigo PC Lira, MD

Organizational Affiliation

University of Campinas, Brazil

Official's Role

Study Chair

Facility Information:

Facility Name

State University of Campinas

City

Campinas

State/Province

Sao Paulo

ZIP/Postal Code

13083887

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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29127949

Citation

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Results Reference

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Results Reference

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

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