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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
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diffuse Diabetic Macular Edema Drug: Triamcinolone Acetonide and Bevacizumab Phase 3

Study Design

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600301

Contact: Maximiliano Gordon, MD 10841400 ext 1171, 1172 retinamex@yahoo.com

Asociacion Para Evitar la Ceguera en Mexico Recruiting
Mexico D.F., D.f., Mexico, 04030
Contact: Maximiliano Gordon, MD    10841400 ext 1171, 1172    retinamex@yahoo.com   
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Principal Investigator: Maximiliano Gordon, MD APEC
More Information

ClinicalTrials.gov Identifier: NCT00600301     History of Changes
Other Study ID Numbers: APEC-OO13
First Posted: January 24, 2008    Key Record Dates
Last Update Posted: January 24, 2008
Last Verified: January 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