Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema (Tribeva-DME)

March 31, 2009 updated by: Universidade Federal de Goias

Phase 2 Study of Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema.

The purpose of this study is to compare a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab for the treatment of diabetic macular edema.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparison a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab regarding the ability of central macular thickness reduction. Secondary objectives are analysis of Visual Outcomes and variations on Intraocular Pressure. The patients data were statistically analyzed if there was a 24 week follow up completed.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetic macular edema with central foveal measurement over 300 micrometers

Exclusion Criteria:

  • Glaucoma
  • Vitreoretinal surgery
  • Cataract Surgery less than 3 months prior inclusion
  • Unilateral cataract surgery
  • Uncontrolled Glycosylated Hemoglobin
  • Previous Intraocular Injection
  • Systemic Corticosteroids less than 1 month prior inclusion
  • Macular ischemia at Fluorescein Angiography
  • Cataract precluding fundus examination
  • Active Proliferative Diabetic Retinopathy

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bevacizumab
Drug: Bevacizumab
1.25mg bevacizumab (0.05ml)
Other Names:
  • 1.Bevacizumab
  • 2.Avastin
Experimental: Triamcinolone
Drug: Triamcinolone acetonide
4.0 mg Triamcinolone acetonide injection
Other Names:
  • 1. Theracort
  • 2. Kenalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison between the efficacy of a single intravitreal injection of 4.0mg of triamcinolone acetonide or 1.25mg of bevacizumab in the treatment of diabetic macular edema
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare Visual Acuity between the same drug in Initial visit, 4, 12 ans 24 weeks and Visual Acuity between two group of eyes treated with different drugs.
Time Frame: 6 months
6 months
To compare Intraocular Pressure between the same drug in Initial visit, 4, 12 ans 24 weeks and Intraocular Pressure between two group of eyes treated with different drugs.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Goias

Investigators

  • Principal Investigator: David LC Isaac, MD, PhD, Universidade Federal de Goias

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

March 31, 2009

First Submitted That Met QC Criteria

March 31, 2009

First Posted (Estimate)

April 2, 2009

Study Record Updates

Last Update Posted (Estimate)

April 2, 2009

Last Update Submitted That Met QC Criteria

March 31, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cerof-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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