POSTERIOR SUB-TENON'S Avastin

December 5, 2008 updated by: Asociación para Evitar la Ceguera en México

POSTERIOR SUB-TENON'S CAPSULE INJECTION OF BEVACIZUMAB FOR TREATMENT OF DIFFUSE DIABETIC MACULAR EDEMA

Posterior sub-tenon's injection of bevacizumab decreased diffuse diabetic macular edema

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

7

Phase

  • Phase 4

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 Locations

  • Mexico
    • DF
      • Mexico DF, DF, Mexico, 04030
        • Recruiting
        • Asociación Para Evitar la Ceguera en México
        • Contact:

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with diffuse diabetic macular edema non-proliferative diabetic retinopathy Maculat thickness ≥250 μ BCVA ≥ 20/400 Without any treatment

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
macular volume
Time Frame: baseline, 3,6 and 12 weeks
baseline, 3,6 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
macular thickness
Time Frame: baseline,3,6 and 12 weeks
baseline,3,6 and 12 weeks
best corrected visual acuity
Time Frame: baseline, 3,6 and 12 weeks
baseline, 3,6 and 12 weeks

Collaborators and Investigators

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

Sponsor

Asociación para Evitar la Ceguera en México

Investigators

  • Principal Investigator: Sandra Vera, MD, Asociación Para Evitar la Ceguera en México
  • Principal Investigator: Hugo Quiroz-Mercado, MD, Denver Health Medical Center
  • Principal Investigator: Adai Pérez-Montesinos, MD, 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

June 1, 2008

Primary Completion (Anticipated)

November 1, 2008

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

November 30, 2007

First Submitted That Met QC Criteria

December 3, 2007

First Posted (Estimate)

December 4, 2007

Study Record Updates

Last Update Posted (Estimate)

December 8, 2008

Last Update Submitted That Met QC Criteria

December 5, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00922

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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