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 because the information has not been verified recently.
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Genders Eligible for Study:   Both

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority: Mexico: Secretaria de Salud

Keywords provided by Asociación para Evitar la Ceguera en México:

Additional relevant MeSH terms:
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 26, 2016