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

Universidade Federal de Pernambuco

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03608839

003

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 3 patient groups

0,01ml dexamethasone solution

Experimental group

Description:

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

Treatment:

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

0,03 ml dexamethasone solution

Experimental group

Description:

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

Treatment:

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

0,05 ml dexamethasone solution

Experimental group

Description:

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

Treatment:

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