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Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Asociación para Evitar la Ceguera en México.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00346814
First received: June 29, 2006
Last updated: June 28, 2009
Last verified: June 2006
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

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

Ages Eligible for Study:   1 Month to 12 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00346814     History of Changes
Other Study ID Numbers: APEC-001
Study First Received: June 29, 2006
Last Updated: June 28, 2009
Health Authority: Mexico: Ministry of Health

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

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Angiogenesis Inhibitors
Bevacizumab
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013