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Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00571142
First received: December 7, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted

December 7, 2007
December 7, 2007
November 2007
Not Provided
Retinal thickness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Visual acuity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema
Pars Plana Vitrectomy and Bevacizumab for the Treatment of Diffuse Diabetic Macular Edema (A Pilot Study)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
* Diffuse Diabetic Macular Edema
  • 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
  • Active Comparator: 1
    Renal disease
    Intervention: Procedure: Bevacizumab + Pars plana vitrectomy
  • Active Comparator: 2
    Without renal disease
    Intervention: Procedure: Bevacizumab + pars plana vitrectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
February 2008
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • Another retinal disease
  • Pregnancy
Both
25 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00571142
APEC-ret
No
Not Provided
Not Provided
Veronica Kon-Jara MD, Asociacion para Evitar la Ceguera en Mexico I.A.P.
Asociación para Evitar la Ceguera en México
Not Provided
Principal Investigator: Veronica Kon-Jara, MD Asociación para Evitar la Ceguera en México
Asociación para Evitar la Ceguera en México
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP