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

Universidade Federal de Goias

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: Bevacizumab; Drug: Triamcinolone acetonide

Study type: Interventional

Funder types: Other

Identifiers

NCT00874744

Cerof-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13 participants in 2 patient groups

bevacizumab

Experimental group

Treatment:

Drug: Bevacizumab

Triamcinolone

Experimental group

Treatment:

Drug: Triamcinolone acetonide