Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema

Overview

To Evaluate combined effect of vitrectomy and bevacizumab to stabilize retinal thickness and visual acuity in patients with diffuse diabetic macular edema and their relation to renal disease.

Full Title of Study: “Pars Plana Vitrectomy and Bevacizumab for the Treatment of Diffuse Diabetic Macular Edema (A Pilot Study)”

Study Type

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

Interventions

  • Procedure: Bevacizumab + Pars plana vitrectomy
    • 2.5 mg / 0.1 ml bevacizumab after pars plana vitrectomy. Limitorexis would be optional.
  • Procedure: Bevacizumab + pars plana vitrectomy
    • 2.5 mg /0.1 ml of bevacizumab after pars plana vitrectomy

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Renal disease
  • Active Comparator: 2
    • Without renal disease

Clinical Trial Outcome Measures

Primary Measures

  • Retinal thickness
    • Time Frame: 3 months

Secondary Measures

  • Visual acuity
    • Time Frame: 3 months

Participating in This Clinical Trial

Inclusion Criteria

  • Older than 25 yo
  • Diffuse diabetic macular edema with or without previous treatment

Exclusion Criteria

  • Another retinal disease
  • Pregnancy

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Asociación para Evitar la Ceguera en México
  • Provider of Information About this Clinical Study
    • Veronica Kon-Jara MD, Asociacion para Evitar la Ceguera en Mexico I.A.P.
  • Overall Official(s)
    • Veronica Kon-Jara, MD, Principal Investigator, Asociación para Evitar la Ceguera en México
  • Overall Contact(s)
    • Veronica Kon-Jara, MD, 5215537291895, veronicakon@yahoo.com

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