Suspended

IBEMEIntravitreal Bevacizumab Versus Intravitreal Triamcinolone Acetonide for Refractory Diabetic Macular Edema

What is being tested

Data Collection

Who is being recruted

Diabetes Mellitus+7

+ Endocrine System Diseases

+ Eye Diseases

Over 18 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: April 2006

See protocol details

Summary

Principal SponsorUniversity of Sao Paulo

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2006

Actual date on which the first participant was enrolled.

Intravitreal triamcinolone has been effective for central macular thickness reduction and concomitant visual acuity improvement in patients with diabetic macular edema (DME). VEGF is a very effective inducer of permeability, being 50.000 times more potent than histamine, and may exert its effect on retinal vascular permeability by altering tight-junctions proteins, such as occluding and VE-cadherin. Based on these principles, there is a rationale for anti-VEGF agents treatment of increased retinal capillary permeability conditions, such as diabetic macular edema. Therefore, we conducted a randomized, prospective study to compare the efficacy and safety of intravitreal triamcinolone acetonide and intravitreal bevacizumab injection for refractory diffuse DME.

Official TitleIntravitreal Bevacizumab Versus Intravitreal Triamcinolone Acetonide for Refractory Diabetic Macular Edema

NCT00468351

Principal SponsorUniversity of Sao Paulo

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesEye DiseasesMacular DegenerationMacular EdemaMetabolic DiseasesNutritional and Metabolic DiseasesRetinal DegenerationRetinal DiseasesGlucose Metabolism Disorders

Criteria

2 inclusion criteria required to participate

Refractory diffuse DME (defined herein as clinically significant DME [by biomicroscopic evaluation] unresponsive to focal laser photocoagulation [performed at least 3 months before evaluation] and generalized breakdown of the inner blood-retina barrier with diffuse fluorescein leakage involving the foveal center and most of the macular area on fluorescein angiography),

Snellen logarithm of minimum angle of resolution (LogMAR) BCVA equivalent of 20/40 or worse, and 3) central macular thickness (CMT) greater than 300µm on optical coherence tomography (OCT)

11 exclusion criteria prevent from participating

History of thromboembolic event (including myocardial infarction or cerebral vascular accident);

Major surgery within the prior 6 months or planned within the next 28 days;

Systemic corticoid therapy,.

Aphakic or pseudophakic eyes,

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, BrazilOpen Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto in Google Maps

SuspendedOne Study Center