Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Macular Thickness at 3 Days After Intravitreous Dexamethasone
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
0,01ml dexamethasone solution
One intravitreous injection of 0,01 ml dexamethasone solution 4 mg/ml.
Intervention: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml (Drug)
0,03 ml dexamethasone solution
One intravitreous injection of 0,03 ml dexamethasone solution 4 mg/ml.
Intervention: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml (Drug)
0,05 ml dexamethasone solution
One intravitreous injection of 0,05 ml dexamethasone solution 4 mg/ml.
Intervention: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml (Drug)
Outcomes
Primary Outcomes
Macular Thickness at 3 Days After Intravitreous Dexamethasone
Time Frame: Three days after intravitreous dexamethasone
Measure macular thickness at 3 days after intravitreous dexamethasone with OCT - unit µm
Secondary Outcomes
- Macular Thickness at 28 Days After Intravitreous Dexamethasone(28 days after intravitreous dexamethasone)
- Best Corrected Visual Acuity (BCVA) at 3 Days After Intravitreous Dexamethasone(Three days after intravitreous dexamethasone)
- Best Corrected Visual Acuity (BCVA) at 28 Days After Intravitreous Dexamethasone(28 days after intravitreous dexamethasone)
- Intraocular Pressure (IOP) at 3 Days After Intravitreous Dexamethasone(3 days after intravitreous dexamethasone)
- Intraocular Pressure (IOP) at 28 Days After Intravitreous Dexamethasone(28 days after intravitreous dexamethasone)
Investigators
Rodrigo Pessoa Cavalcanti Lira
Principal Investigator
Universidade Federal de Pernambuco