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

Information source: Universidade Federal de Goias
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Macular Edema

Intervention: Bevacizumab (Drug); Triamcinolone acetonide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Universidade Federal de Goias

Official(s) and/or principal investigator(s):
David LC Isaac, MD, PhD, Principal Investigator, Affiliation: Universidade Federal de Goias

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.

Clinical Details

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

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

Primary outcome: 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:

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.

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.

Eligibility

Minimum age: 40 Years. Maximum age: 90 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: March 2008
Last updated: March 31, 2009

Page last updated: August 23, 2015

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