Intravitreal Bevacizumab and Triamcinolone Associated to Laser Photocoagulation for Diabetic Macular Edema(IBeTA)
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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, the purpose of this study is to evaluate the effects of intravitreal bevacizumab and intravitreal triamcinolone associated to laser photocoagulation for diabetic macular edema.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Macular Edema |
Procedure: Laser photocoagulation Drug: Intravitreal triamcinolone Drug: Intravitreal bevacizumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intravitreal Bevacizumab and Intravitreal Triamcinolone Associated to Laser Photocoagulation for Diabetic Macular Edema(IBeTA) |
- Best Corrected Visual acuity [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
- Macular Mapping Test [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
- Multifocal Electroretinogram [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
- Central Macular Thickness [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
| Enrollment: | 12 |
| Study Start Date: | October 2009 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Laser Group
Focal / grid Laser photocoagulation in diabetic macular edema
|
Procedure: Laser photocoagulation
Focal / grid photocoagulation for diabetic macular edema according to ETDRS guidelines
|
|
Experimental: Triamcinolone group
Intravitreal triamcinolone associated to laser photocoagulation for diabetic macular edema
|
Drug: Intravitreal triamcinolone
Intravitreal preservative-free triamcinolone (4mg) associated to focal photocoagulation for diabetic macular edema on baseline; Re-treatment at weeks 20 and 40 if CMT>275um
Other Name: Triancinolona (Ophthalmos)
|
|
Experimental: Bevacizumab group
Intravitreal Bevacizumab associated to laser photocoagulation for diabetic macular edema
|
Drug: Intravitreal bevacizumab
Intravitreal bevacizumab (1.5mg) associated to focal photocoagulation for diabetic macular edema at baseline; Re-treatment at weeks 20 and 40 if CMT>275um
Other Name: Avastin
|
Detailed Description:
Macular edema is a leading cause of decreased visual acuity in patients with diabetic retinopathy1,2.
Laser photocoagulation is the standard of care treatment for diabetic macular edema, based on ETDRS and recent clinical trials findings3,4. However, because visual acuity improvement post-laser is observed infrequently, and because of the frequent recurrence or persistence of DME (refractory DME) after appropriate laser treatment, particularly in eyes presenting with angiographically diffuse macular edema5-9, there is a need for alternative treatments for the management of DME. In addition, for some patients with significant cataract, precise visualization of posterior pole structures may not be possible, so that pharmacological therapy with intravitreal agents may be preferable over laser treatment.
Recent studies have shown promising results of pharmacological therapies for Diabetic macular edema. Triamcinolone has shown similar results when compared to ranibizumab and deferred focal/grid LASER in pseudophakic eyes (DRCRnet, prompt versus deferred). Ranibizumab associated with deferred LASER or as monotherapy has also shown promising results (RISE and RIDE). However, there are several concerns regarding long-term intravitreal injections therapies that include economic feasibility for the public health system, risk of endophthalmitis and patient acceptability. For these reasons, the present study decided to check associations between LASER and drug therapy, in an attempt to improve focal/grid laser outcomes with reduced number of intravitreal injections.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinically significant DME - by biomicroscopic evaluation with 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 20/40 or worse
- Central macular thickness greater than 275 µm on optical coherence tomography (OCT)
Exclusion Criteria:
- Glycosylated hemoglobin rate above 10%
- History of glaucoma or ocular hypertension
- 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
- Severe systemic disease
- Any condition affecting documentation or follow-up
Contacts and Locations| Brazil | |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto | |
| Ribeirão Preto, São Paulo, Brazil | |
| Study Chair: | Maria L Paccola, MD | HC FMRP - USP |
| Study Chair: | André M V Messias, PhD | HCFMRP - USP |
| Study Director: | Bianka Y N Y Katayama, MD | HC FMRP - USP |
| Principal Investigator: | Rodrigo Jorge, PhD | HC FMRP - USP |
| Study Chair: | Rogério A Costa, PhD | HC FMRP - USP |
More Information
Publications:
| Responsible Party: | Rodrigo Jorge, Professor, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT00997191 History of Changes |
| Other Study ID Numbers: | 6826/2009 |
| Study First Received: | October 15, 2009 |
| Last Updated: | February 28, 2013 |
| 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 22, 2013