Intravitreal Bevacizumab for Diabetic Retinopathy

January 23, 2008 updated by: Asociación para Evitar la Ceguera en México

Efficacy of Intravitreal Bevacizumab for Severe Nonproliferative and Proliferative Diabetic Retinopathy.

Background: to evaluate the 3-month efficacy of a single dose of intravitreal bevacizumab on the progression of severe non proliferative diabetic retinopathy, proliferative diabetic retinopathy and active photocoagulated diabetic proliferative by evaluation of ischemic areas and regression of retinal and disc neovasculrization.

Methods: 40 patients were enrolled in a prospective, interventional study. Patients were treated with intravitreal bevacizumab 0.1ml (0.25mg). We evaluated visual acuity, neovascularization leakage points, capillary closure ischemic areas and macular edema by clinical examination and fluorescein angiography. A clinical examination was performed at baseline and days 1,14 and 30. Active leakage points were measured by fluorescein angiography at 30 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • 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 Locations

  • Mexico
      • Mexico City, Mexico, 04030
        • Elizabeth Reyna Castelan

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Severe nonproliferative
  • Proliferative diabetic retinopathy
  • Active photocoagulated diabetic retinopathy

Exclusion Criteria:

  • Previous vascular occlusion
  • Glaucoma
  • Uncontrolled hypertension, thromboembolic event
  • Renal abnormalities
  • Recent or planned surgery
  • Coagulation abnormalities
  • Panretinal photocoagulation of less than one month before
  • Patients with known serious allergies

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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

  • Study Chair: Mariana Martinez-Castellanos, MD, Asociación Para Evitar la Ceguera en México
  • Principal Investigator: Elizabeth Reyna-Castelan, 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

December 1, 2005

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

June 29, 2006

First Submitted That Met QC Criteria

January 23, 2008

First Posted (Estimate)

January 24, 2008

Study Record Updates

Last Update Posted (Estimate)

January 24, 2008

Last Update Submitted That Met QC Criteria

January 23, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APEC-004

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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