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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

This study is currently recruiting participants.
Verified by Asociación para Evitar la Ceguera en México, January 2008

Sponsored by: Asociación para Evitar la Ceguera en México
Information provided by: Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier: NCT00600301
  Purpose

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 III

Genetics Home Reference related topics:   X-linked juvenile retinoschisis   

MedlinePlus related topics:   Edema   

Drug Information available for:   Bevacizumab    Triamcinolone acetonide    Triamcinolone    Triamcinolone diacetate    Triamcinolone hexacetonide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
  Eligibility
Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600301

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

Locations
Mexico, D.F.
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

Investigators
Principal Investigator:     Maximiliano Gordon, MD     APEC    
  More Information


Study ID Numbers:   APEC-OO13
First Received:   June 30, 2006
Last Updated:   January 23, 2008
ClinicalTrials.gov Identifier:   NCT00600301
Health Authority:   Mexico: Secretaria de Salud

Keywords provided by Asociación para Evitar la Ceguera en México:
Macula  
Edema  

Study placed in the following topic categories:
Eye Diseases
Edema
Macular Degeneration
Retinal Degeneration
Triamcinolone diacetate
Bevacizumab
Triamcinolone hexacetonide
Macular Edema
Signs and Symptoms
Triamcinolone Acetonide
Triamcinolone
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Glucocorticoids
Hormones
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on October 28, 2008




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