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

NCT03608839 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2019-10-08

Study results available
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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

Conditions

Interventions

DRUG

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

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

DRUG

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

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

DRUG

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

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

Sponsors & Collaborators

  • Universidade Federal de Pernambuco

    lead OTHER

Principal Investigators

  • Rodrigo PC Lira, MD · University of Campinas, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-01
Primary Completion
2017-12-20
Completion
2018-10-05

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03608839 on ClinicalTrials.gov