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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Triamcinolone Acetonide and Bevacizumab

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 90 Years

Lead Sponsor: Asociación para Evitar la Ceguera en México

Overall Clinical Trial Officials and Contacts

Maximiliano Gordon, MD Principal Investigator APEC  

Overall Contact: Maximiliano Gordon, MD 10841400 retinamex@yahoo.com

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00600301

Study ID Number: APEC-OO13

ClinicalTrials.gov Identifier: NCT00600301

Health Authority: Mexico: Secretaria de Salud