Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema

Diffuse Diabetic Macular Edema Clinical Trial

Official title:

Pars Plana Vitrectomy and Bevacizumab for the Treatment of Diffuse Diabetic Macular Edema (A Pilot Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00571142
• Other study ID #: APEC-ret
• Status: Terminated
• Phase: Phase 3
• Start date: November 2007
• Est. completion date: February 2008

Study information

• Verified date: May 2024
• Source: Asociación para Evitar la Ceguera en México
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: February 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Another retinal disease
• Pregnancy

Related Conditions & MeSH terms

• Diffuse Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

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

Locations

Country	Name	City	State
Mexico	Asociacion para Evitar la Ceguera en Mexico I.A.P.	Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Asociación para Evitar la Ceguera en México

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal thickness		3 months
Secondary	Visual acuity		3 months