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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00874744

Acronym

Tribeva-DME

Enrollment

Registered

2009-04-02

Start date

2008-03-31

Completion date

2008-10-31

Last updated

2009-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Keywords

Diabetic macular edema, intravitreal injection, Pharmacological treatment

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.

Interventions

DRUGBevacizumab

1.25mg bevacizumab (0.05ml)

DRUGTriamcinolone acetonide

4.0 mg Triamcinolone acetonide injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

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

Design outcomes

Primary

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	6 months

Secondary

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.	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.	6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026