Clinical trial NCT03608839: Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial
Official title: Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Keywords: Diabetic macular edema
Intravitreal dexamethasone solution
Short term treament
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Macular Thickness at 3 Days After Intravitreous Dexamethasone
timeFrame: Three days after intravitreous dexamethasone
Secondary outcomes:
measure: Macular Thickness at 28 Days After Intravitreous Dexamethasone
timeFrame: 28 days after intravitreous dexamethasone
measure: Best Corrected Visual Acuity (BCVA) at 3 Days After Intravitreous Dexamethasone
timeFrame: Three days after intravitreous dexamethasone
measure: Best Corrected Visual Acuity (BCVA) at 28 Days After Intravitreous Dexamethasone
timeFrame: 28 days after intravitreous dexamethasone
measure: Intraocular Pressure (IOP) at 3 Days After Intravitreous Dexamethasone
timeFrame: 3 days after intravitreous dexamethasone
measure: Intraocular Pressure (IOP) at 28 Days After Intravitreous Dexamethasone
timeFrame: 28 days after intravitreous dexamethasone
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: State University of Campinas
state: Sao Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Rodrigo PC Lira, MD
role: STUDY_CHAIR
References:
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