Intravitreal Triamcinolone Acetonide Versus Intravitreal Bevacizumab for Refractory Diabetic Macular Edema (IBEME Study)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University of Sao Paulo.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Sao Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00468351
First received: May 1, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
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Purpose
Intravitreal triamcinolone has been effective for central macular thickness reduction and concomitant visual acuity improvement in patients with diabetic macular edema (DME). VEGF is a very effective inducer of permeability, being 50.000 times more potent than histamine, and may exert its effect on retinal vascular permeability by altering tight-junctions proteins, such as occluding and VE-cadherin. Based on these principles, there is a rationale for anti-VEGF agents treatment of increased retinal capillary permeability conditions, such as diabetic macular edema. Therefore, we conducted a randomized, prospective study to compare the efficacy and safety of intravitreal triamcinolone acetonide and intravitreal bevacizumab injection for refractory diffuse DME.
| Condition | Intervention | 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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Intravitreal Bevacizumab Versus Intravitreal Triamcinolone Acetonide for Refractory Diabetic Macular Edema |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Edema
Drug Information available for:
Triamcinolone diacetate
Triamcinolone acetonide
Triamcinolone
Triamcinolone hexacetonide
Bevacizumab
U.S. FDA Resources
Further study details as provided by University of Sao Paulo:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468351
Locations
| Brazil | |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto | |
| Ribeirão Preto, São Paulo, Brazil, 14049-900 | |
Sponsors and Collaborators
University of Sao Paulo
Investigators
| 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 |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00468351 History of Changes |
| Other Study ID Numbers: | 154342005 |
| Study First Received: | May 1, 2007 |
| Last Updated: | May 1, 2007 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Sao Paulo:
|
bevacizumab diabetes intravitreal |
macular edema triamcinolone VEGF |
Additional relevant MeSH terms:
|
Edema Macular Edema Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Bevacizumab Anti-Inflammatory Agents Therapeutic Uses |
Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013