Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

June 28, 2009 updated by: Asociación para Evitar la Ceguera en México
Purpose:Retinopathy of prematurity (ROP) continues tobe a major cause of blindness in children. Although ablation of the retina with laser or cryotherapy reduces the incidence of blindness by suppressing the neovascular phase of ROP the visual outcomes after treatment are often poor. Vascular endothelial growth factor(VEGF) has an important role in the pathogenesis of ROP and inhibition of VEGF expression in the neovascular phase might prevent destructive neovascularization in ROP. The aim of this study is to determine the safety and efficacy of intravitreal bevacizumab in the treatment of retinopathy of prematurity

Study Overview

Status

Unknown

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 Contact

Study Contact Backup

  • Name: Maria A Martinez-Castellanos, MD
  • Phone Number: 1171 525510841400
  • Email: retinamex@yahoo.com

Study Locations

  • Mexico
    • Mexico DF
      • Mexico City, Mexico DF, Mexico, 04030
        • Recruiting
        • Asociación para Evitar la Ceguera en México Hospital "Luis Sanchez Bulnes"
        • Sub-Investigator:
          • Jans Fromow-Guerra, MD
        • Contact:
        • Principal Investigator:
          • Maria Martinez-Castellanos, MD
        • Sub-Investigator:
          • Hugo A Quiroz-Mercado, MD
        • Sub-Investigator:
          • Myriam L Hernandez-Rojas, 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

1 month to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Retinopathy of prematurity stages III, IV and V in which we can not treat with laser o cryotherAPY

Exclusion Criteria:

  • PATIENTS THAT COULD BE TREATED WITH CRYOTHERAPY OR LASER

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical appearance

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: Maria Martínez-Castellanos, 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

July 1, 2006

Study Completion (Anticipated)

November 1, 2006

Study Registration Dates

First Submitted

June 29, 2006

First Submitted That Met QC Criteria

June 29, 2006

First Posted (Estimate)

June 30, 2006

Study Record Updates

Last Update Posted (Estimate)

June 30, 2009

Last Update Submitted That Met QC Criteria

June 28, 2009

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APEC-001

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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