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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2008 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
Information provided by:
Asociación para Evitar la Ceguera en México Identifier:
First received: June 30, 2006
Last updated: January 23, 2008
Last verified: January 2008
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.

Condition Intervention Phase
Diffuse Diabetic Macular Edema Drug: Triamcinolone Acetonide and Bevacizumab Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Asociación para Evitar la Ceguera en México:


Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00600301

Contact: Maximiliano Gordon, MD 10841400 ext 1171, 1172

Asociacion Para Evitar la Ceguera en Mexico Recruiting
Mexico D.F., D.f., Mexico, 04030
Contact: Maximiliano Gordon, MD    10841400 ext 1171, 1172   
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Principal Investigator: Maximiliano Gordon, MD APEC
  More Information Identifier: NCT00600301     History of Changes
Other Study ID Numbers: APEC-OO13
Study First Received: June 30, 2006
Last Updated: January 23, 2008

Keywords provided by Asociación para Evitar la Ceguera en México:

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone diacetate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017