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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Rodrigo Jorge, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00997191
First received: October 15, 2009
Last updated: February 28, 2013
Last verified: February 2013

October 15, 2009
February 28, 2013
October 2009
November 2011   (final data collection date for primary outcome measure)
Best Corrected Visual acuity [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00997191 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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)

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Macular Edema
  • 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 Name: 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 Name: Avastin
  • Active Comparator: Laser Group
    Focal / grid Laser photocoagulation in diabetic macular edema
    Intervention: Procedure: Laser photocoagulation
  • Experimental: Triamcinolone group
    Intravitreal triamcinolone associated to laser photocoagulation for diabetic macular edema
    Intervention: Drug: Intravitreal triamcinolone
  • Experimental: Bevacizumab group
    Intravitreal Bevacizumab associated to laser photocoagulation for diabetic macular edema
    Intervention: Drug: Intravitreal bevacizumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00997191
6826/2009
Yes
Rodrigo Jorge, University of Sao Paulo
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
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
University of Sao Paulo
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP