Clinical trial NCT03608839
Conditions: Diabetic Macular Edema
Keywords: Diabetic macular edema Intravitreal dexamethasone solution Short term treament
Sponsor: Universidade Federal de Pernambuco
Start date: 2016-05-01; Completion date: 2018-10-05
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml. arm 2: One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml. arm 3: One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.
Interventions: intervention 1: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml intervention 2: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml intervention 3: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml
Intervention descriptions: intervention 1: 0,01 ml intravitreous dexamethasone solution 4mg/ml injection. intervention 2: 0,03 ml intravitreous dexamethasone solution 4mg/ml injection. intervention 3: 0,05 ml intravitreous dexamethasone solution 4mg/ml injection.

Protocol documents:
Prot_SAP_000.pdf: 
Official Title of the study: 
Effect of Dexamethasone on Reduction of Macular Thickness in 
Diabetic Patients, a Randomized Clinical Trial 
 
 
 
 
 
 
NCT number 
NCT03608839 
 
 
 
 
 
 
 
 
 
Date of the document 
October 2, 2019 
 
 
 


Study Protocol: 
Data from DME diagnosed volunteers was collected and analyzed at the Department of 
Ophthalmology, State University of Campinas (UNICAMP), Brazil between May 2016 
and December 2017. 
Inclusion criteria included: (1) aged 18 years or over; (2) diagnosis of Type 2 DM; (3) 
patients with pseudophakic eyes; (4) presence of clinically significant DME according to 
ETDRS guidelines; (5) best corrected visual acuity (BCVA) between 20/400 and 20/40; 
(5) central macular thickness (CMT) of >= 300 µm, measured by spectral domain optical 
coherence tomography (Spectralis® Heidelberg). If both eyes met eligibility criteria, the 
eye with worse BCVA at baseline was used as the study eye. 
Exclusion criteria were: (1) any treatment of DME in the previous 4 months; (2) pan 
retinal photocoagulation (PRP) in the last 4 months or likelihood of necessity to undergo 
PRP during the next 6 months; (3) any ophthalmologic surgery performed in the last 4 
months; (4) history of pars plana vitrectomy (PPV); (5) history of open-angle glaucoma or 
corticosteroid-induced elevated intraocular pressure that required antiglaucoma or anti-
hypertensive ocular treatments; (6) intraocular pressure of >= 21 mmHg; (7) patients that 
refused to sign the informed consent form. 
During the screening consultation, complete ophthalmic evaluation, including BCVA, slit-
lamp biomicroscopy, applanation tonometry, fundus biomicroscopy, fluorescein 
angiography (Visucam NM/ FA Carl Zeiss; Carl Zeiss Meditec, California, USA) and SD- 
OCT (Spectralis; Heidelberg Engineering, Heidelberg, Germany) was performed. CMT 
was obtained through seven horizontal lines (30° x 5° area), centered on the fovea, with 
1536 A scans per line at 240 µm intervals. 
Patients were randomized via a 1:1:1 sequential allocation to receive 0.01 ml (40µg), 
0.03 ml (120µg), or 0.05 ml (200µg) of the 4mg/ml dexamethasone solution during the 
primary study visit (baseline). In subsequent visits, at one, three, seven, 14, 21, and 28 
days, analysis via BCVA, slit-lamp biomicroscopy, applanation tonometry, fundus 
biomicroscopy, and SD-OCT (Spectralis; Heidelberg Engineering, Heidelberg, Germany) 
was performed. 
The current study used blocked randomization (3 groups with 9 
members each); data was computer generated, and stored in a locked 
cabinet until the end of the study period. Patients, study personnel 
responsible for intravitreal injections and those responsible for collecting 
BCVA, IOP, OCT data were blinded as to the patient study assignment. 
 
Statistical Analysis Plan: 
Calculations based on effect size at 0.5 standard deviations of macular thickness 
between pre injection (baseline) and the 3rdday post injection indicated that a sample 
size consisting 27 subjects would be sufficient for detecting a difference of this 
magnitude with a power of 0.8 and a significance level of 0.05 (one-tailed). 
In statistical analysis, continuous data were expressed as the mean ± standard deviation 
and range. Between-group differences of continuous variables were compared using 
Kruskal-Wallis 1-way ANOVA, Wilcoxon Signed Ranks Test or Mann–Whitney U test 
when appropriate, and categorical variables were compared using or Fisher – Freeman 
– Halton exact test. Analyses were performed using IBM SPSS Statistics version 20. 
Statistical significance was established when p≤0.05.