Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema

• Sponsor: Asociación para Evitar la Ceguera en México (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00571142
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
* Diffuse Diabetic Macular Edema	Procedure: Bevacizumab + Pars plana vitrectomy; Procedure: Bevacizumab + pars plana vitrectomy	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pars Plana Vitrectomy and Bevacizumab for the Treatment of Diffuse Diabetic Macular Edema (A Pilot Study)
• Study Start Date: Nov 1, 2007
• Anticipated Study Completion Date: Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Renal disease	Procedure: Bevacizumab + Pars plana vitrectomy; 2.5 mg / 0.1 ml bevacizumab after pars plana vitrectomy. Limitorexis would be optional.
Active Comparator: 2 Without renal disease	Procedure: Bevacizumab + pars plana vitrectomy; 2.5 mg /0.1 ml of bevacizumab after pars plana vitrectomy

Outcome Measures

Primary Outcome Measures

1. Retinal thickness [3 months]

Secondary Outcome Measures

1. Visual acuity [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Older than 25 yo

• Diffuse diabetic macular edema with or without previous treatment

Exclusion Criteria:

• Another retinal disease

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asociacion para Evitar la Ceguera en Mexico I.A.P.	Mexico		Mexico	04030

Sponsors and Collaborators

• Asociación para Evitar la Ceguera en México

Investigators

• Principal Investigator: Veronica Kon-Jara, MD, Asociación para Evitar la Ceguera en México

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00571142
• Other Study ID Numbers: APEC-ret
• First Posted: Dec 11, 2007
• Last Update Posted: Dec 11, 2007
• Last Verified: Dec 1, 2007

• Keywords provided by , ,: edema; retinal thickness; diabetic retinopathy
• Additional relevant MeSH terms: Macular Edema; Edema; Bevacizumab; Temazepam

Study Results

No Results Posted as of Dec 11, 2007