Intravitreal Triamcinolone Acetonide Versus Intravitreal Bevacizumab for Refractory Diabetic Macular Edema (IBEME Study) (IBEME)
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ClinicalTrials.gov Identifier: NCT00468351 |
Recruitment Status : Unknown
Verified April 2007 by University of Sao Paulo.
Recruitment status was: Active, not recruiting
First Posted : May 2, 2007
Last Update Posted : May 2, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Macular Edema | Procedure: Intravitreal Injection of 1,5 mg of bevacizumab Procedure: Intravitreal injection of 4 mg of Triamcinolone acetonide | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Primary Purpose: | Treatment |
Official Title: | Intravitreal Bevacizumab Versus Intravitreal Triamcinolone Acetonide for Refractory Diabetic Macular Edema |
Study Start Date : | April 2006 |
Study Completion Date : | April 2007 |

- Central Macular Thickness, Best Corrected Visual Acuity [ Time Frame: six months ]
- Intraocular pressure; lens status [ Time Frame: six months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Refractory diffuse DME (defined herein as clinically significant DME [by biomicroscopic evaluation] unresponsive to focal laser photocoagulation [performed at least 3 months before evaluation] and generalized breakdown of the inner blood-retina barrier with diffuse fluorescein leakage involving the foveal center and most of the macular area on fluorescein angiography),
- Snellen logarithm of minimum angle of resolution (LogMAR) BCVA equivalent of 20/40 or worse, and 3) central macular thickness (CMT) greater than 300µm on optical coherence tomography (OCT)
Exclusion Criteria:
- Aphakic or pseudophakic eyes,
- Glycosylated hemoglobin (Hb A1C) rate above 10%,
- History of glaucoma or ocular hypertension,
- Loss of vision as a result of other causes,
- Systemic corticoid therapy,.
- History of thromboembolic event (including myocardial infarction or cerebral vascular accident);
- Major surgery within the prior 6 months or planned within the next 28 days;
- Uncontrolled hypertension (according to guidelines of the seventh report of the joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure [JNC-7]);16
- Known coagulation abnormalities or current use of anticoagulative medication other than aspirin;
- Severe systemic disease; or
- Any condition affecting follow-up or documentation

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): NCT00468351
Brazil | |
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto | |
Ribeirão Preto, São Paulo, Brazil, 14049-900 |
Study Chair: | Rodrigo Jorge, MD, PhD | HCFMRP-USP | |
Study Director: | Rogério A Costa, MD, PhD | Retina Diagnostic and Treatment Division, Hospital de Olhos de Araraquara, Araraquara | |
Principal Investigator: | Rodrigo Jorge, MD, PhD | HCFMRP-USP |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00468351 |
Other Study ID Numbers: |
154342005 |
First Posted: | May 2, 2007 Key Record Dates |
Last Update Posted: | May 2, 2007 |
Last Verified: | April 2007 |
bevacizumab diabetes intravitreal |
macular edema triamcinolone VEGF |
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 |