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Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study

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ClinicalTrials.gov Identifier: NCT00600301
Recruitment Status : Unknown
Verified January 2008 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
First Posted : January 24, 2008
Last Update Posted : January 24, 2008
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México

June 30, 2006
January 24, 2008
January 24, 2008
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No Changes Posted
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Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study
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Diabetic macular edema is the most common cause of visual loss among patients with diabetic retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of diabetic macular edema. Previous report showed a limited improvement in visual acuity and macular thickness posterior intraoperative triamcinolone acetonide. Bevacizumab intravitreal injection has been proven be effective in the treatment of diabetic macular edema, in recent publications. The purpose of this study is to evaluate whether vitrectomy with and without intravitreal triamcinolone acetonide and bevacizumab injection affects vision outcome and macular thickness in patients with diabetic macular edema.
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Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diffuse Diabetic Macular Edema
Drug: Triamcinolone Acetonide and Bevacizumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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Inclusion Criteria:

  • Diffuse diabetic macular edema
  • Non proliferative diabetic retinopathy
  • No VPP previa
  • No previous treament with laser, Triamcinolone acetonide, and Bevacizumab

Exclusion Criteria:

  • Proliferative diabetic retinopathy
  • Previous pars plana vitrectomy
  • Previous treatment with diabetic macular edema
  • Focal macular edema
  • Macular Ischemia
Sexes Eligible for Study: All
20 Years to 90 Years   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT00600301
APEC-OO13
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Asociación para Evitar la Ceguera en México
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Principal Investigator: Maximiliano Gordon, MD APEC
Asociación para Evitar la Ceguera en México
January 2008

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