Phase 2 N=27 Randomized Quadruple-blind Treatment

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

Diabetic Macular Edema

Bottom Line

View on ClinicalTrials.gov: NCT03608839 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Macular Thickness at 3 Days After Intravitreous Dexamethasone — 438.44; 465.22; 368.22 µm

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml (Drug); Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml (Drug); Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Universidade Federal de Pernambuco
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Macular Thickness at 3 Days After Intravitreous Dexamethasone	438.44; 465.22; 368.22	—
SECONDARY Macular Thickness at 28 Days After Intravitreous Dexamethasone	554.66; 617.22; 451.44	—
SECONDARY Best Corrected Visual Acuity (BCVA) at 3 Days After Intravitreous Dexamethasone	54.22; 52.33; 60.22	—
SECONDARY Best Corrected Visual Acuity (BCVA) at 28 Days After Intravitreous Dexamethasone	58.33; 50.55; 64.11	—
SECONDARY Intraocular Pressure (IOP) at 3 Days After Intravitreous Dexamethasone	12.33; 13.11; 12.44	—
SECONDARY Intraocular Pressure (IOP) at 28 Days After Intravitreous Dexamethasone	12.33; 12.44; 11.88	—

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03608839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.