Trial | NCT00997191  Report issue

Title

Intravitreal Bevacizumab and Triamcinolone Associated to Laser Photocoagulation for Diabetic Macular Edema(IBeTA)
Intravitreal Bevacizumab and Intravitreal Triamcinolone Associated to Laser Photocoagulation for Diabetic Macular Edema(IBeTA)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    bevacizumab triamcinolone ...

  • Study Participants

    12
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.
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.
Study Started
Oct 31
2009
Primary Completion
Nov 30
2011
Study Completion
Nov 30
2011
Last Update
Mar 04
2013
Estimate

Procedure Laser photocoagulation

Focal / grid photocoagulation for diabetic macular edema according to ETDRS guidelines

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 names: Triancinolona (Ophthalmos)

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 names: Avastin

Laser Group Active Comparator

Focal / grid Laser photocoagulation in diabetic macular edema

Triamcinolone group Experimental

Intravitreal triamcinolone associated to laser photocoagulation for diabetic macular edema

Bevacizumab group Experimental

Intravitreal Bevacizumab associated to laser photocoagulation for diabetic macular edema

Criteria 

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
No Results Posted