Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema

December 7, 2007 updated by: Asociación para Evitar la Ceguera en México

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Mexico, Mexico, 04030
        • Recruiting
        • Asociación para Evitar la Ceguera en México I.A.P.
        • Sub-Investigator:
          • Ma Ana Martinez-Castellanos, MD
        • Sub-Investigator:
          • Oscar Alvarez-Verduzco, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Another retinal disease
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retinal thickness
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociación para Evitar la Ceguera en México

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Study Completion (ANTICIPATED)

February 1, 2008

Study Registration Dates

First Submitted

December 7, 2007

First Submitted That Met QC Criteria

December 7, 2007

First Posted (ESTIMATE)

December 11, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2007

Last Update Submitted That Met QC Criteria

December 7, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APEC-ret

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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