Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema (Tribeva-DME)
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ClinicalTrials.gov Identifier: NCT00874744 |
Recruitment Status :
Completed
First Posted : April 2, 2009
Last Update Posted : April 2, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Macular Edema | Drug: Bevacizumab Drug: Triamcinolone acetonide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Phase 2 Study of Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema. |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | October 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: bevacizumab |
Drug: Bevacizumab
1.25mg bevacizumab (0.05ml)
Other Names:
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Experimental: Triamcinolone |
Drug: Triamcinolone acetonide
4.0 mg Triamcinolone acetonide injection
Other Names:
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- 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 ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | 40 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874744
Principal Investigator: | David LC Isaac, MD, PhD | Universidade Federal de Goias |
Responsible Party: | David Leonardo Cruvinel Isaac, MD, Federal University of Goiás |
ClinicalTrials.gov Identifier: | NCT00874744 |
Other Study ID Numbers: |
Cerof-001 |
First Posted: | April 2, 2009 Key Record Dates |
Last Update Posted: | April 2, 2009 |
Last Verified: | March 2009 |
Diabetic macular edema intravitreal injection Pharmacological treatment |
Macular Edema Edema Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Triamcinolone Triamcinolone Acetonide Triamcinolone hexacetonide Bevacizumab Triamcinolone diacetate Antineoplastic Agents, Immunological Antineoplastic Agents |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |