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

Diabetic Macular Edema Clinical Trial

— Tribeva-DME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874744
• Other study ID #: Cerof-001
• Status: Completed
• Phase: Phase 2
• First received: March 31, 2009
• Last updated: March 31, 2009
• Start date: March 2008
• Est. completion date: October 2008

Study information

• Verified date: March 2009
• Source: Universidade Federal de Goias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Bevacizumab
1.25mg bevacizumab (0.05ml)
• Triamcinolone acetonide
4.0 mg Triamcinolone acetonide injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Goias

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No