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

Primary Purpose

Diabetic Macular Edema

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Bevacizumab

Triamcinolone acetonide

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic macular edema, intravitreal injection, Pharmacological treatment

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

bevacizumab

Triamcinolone

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT00874744

First Posted

March 31, 2009

Last Updated

March 31, 2009

Sponsor

Universidade Federal de Goias

1. Study Identification

Unique Protocol Identification Number

NCT00874744

Brief Title

Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema

Acronym

Tribeva-DME

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Universidade Federal de Goias

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

Keywords

Diabetic macular edema, intravitreal injection, Pharmacological treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

bevacizumab

Arm Type

Experimental

Arm Title

Triamcinolone

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

1.Bevacizumab, 2.Avastin

Intervention Description

1.25mg bevacizumab (0.05ml)

Intervention Type

Drug

Intervention Name(s)

Triamcinolone acetonide

Other Intervention Name(s)

1. Theracort, 2. Kenalog

Intervention Description

4.0 mg Triamcinolone acetonide injection

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David LC Isaac, MD, PhD

Organizational Affiliation

Universidade Federal de Goias

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema

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