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Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2006 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00346814
First Posted: June 30, 2006
Last Update Posted: June 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Asociación para Evitar la Ceguera en México
  Purpose
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

Condition Intervention Phase
Retinopathy of Prematurity Drug: intravitreal injection Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

Resource links provided by NLM:


Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:
  • Clinical appearance

Study Start Date: July 2006
Estimated Study Completion Date: November 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346814


Contacts
Contact: Hugo Quiroz-Mercado, MD 525510841400 ext 1171 retinamex@yahoo.com
Contact: Maria A Martínez-Castellanos, MD 525510841400 ext 1171 retinamex@yahoo.com

Locations
Mexico
Asociación para Evitar la Ceguera en México Hospital "Luis Sanchez Bulnes" Recruiting
Mexico City, Mexico DF, Mexico, 04030
Contact: Maria A Martinez-Castellanos, MD    525510841400 ext 1171    retinamex@yahoo.com   
Principal Investigator: Maria Martinez-Castellanos, MD         
Sub-Investigator: Hugo A Quiroz-Mercado, MD         
Sub-Investigator: Myriam L Hernandez-Rojas, MD         
Sub-Investigator: Jans Fromow-Guerra, MD         
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Maria Martínez-Castellanos, MD APEC
  More Information

ClinicalTrials.gov Identifier: NCT00346814     History of Changes
Other Study ID Numbers: APEC-001
First Submitted: June 29, 2006
First Posted: June 30, 2006
Last Update Posted: June 30, 2009
Last Verified: June 2006

Keywords provided by Asociación para Evitar la Ceguera en México:
Retinopathy of prematurity
antiangiogenic therapy

Additional relevant MeSH terms:
Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents


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