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Intravitreal Triamcinolone Acetonide Versus Intravitreal Bevacizumab for Refractory Diabetic Macular Edema (IBEME Study)

NCT00468351 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2007-05-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Intravitreal Injection of 1,5 mg of bevacizumab

PROCEDURE

Intravitreal injection of 4 mg of Triamcinolone acetonide

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Rodrigo Jorge, MD, PhD · HCFMRP-USP

  • Rogério A Costa, MD, PhD · Retina Diagnostic and Treatment Division, Hospital de Olhos de Araraquara, Araraquara

  • Rodrigo Jorge, MD, PhD · HCFMRP-USP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Completion
2007-04-30

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 NCT00468351 on ClinicalTrials.gov