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VEGF Levels in Aqueous, Vitreous and Subretinal Fluid in ROP Stage IV and V

This study has been completed.
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00563121
First received: November 21, 2007
Last updated: November 23, 2007
Last verified: November 2007
  Purpose

To determine the degree of VEGF in Aqueous, vitreous and SRF in patients with ROP in stage V. Verifying that it is greater to that found in healthy newborn patients with different ocular pathology.


Condition Intervention Phase
Retinopathy of Prematurity
Procedure: Vitrectomy
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Vascular Endothelial Growth Factor Levels in Aqueous, Vitreous and Subretinal Fluid in Patients With Retinopathy of Prematurity Stage IV and V

Resource links provided by NLM:


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

Primary Outcome Measures:
  • VEGF Levels [ Time Frame: one day ]

Enrollment: 16
Study Start Date: March 2007
Study Completion Date: June 2007
Intervention Details:
    Procedure: Vitrectomy
    Open-Sky vitrectomy, with resection of the tunica vasculosa lentis, and retinal reattachment
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Month to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premature newborns with less than 32 weeks of gestation.
  • Low birth weight (less than 1500gr)
  • Stage V ROP.
  • The parents has signed the informed consent.

Exclusion Criteria:

  • Previous treatment of ROP.
  • Surgery or another ocular pathology of any type.
  • Systemic diseases, including diabetes mellitus, congestive heart failure acute renal insufficiency, Chronic renal insufficiency, high blood pressure.
  • Lack of Informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563121

Locations
Mexico
Asociación para Evitar la Ceguera en Mexico
Mexico, DF, Mexico, 04030
Asociacion Para Evitar la Ceguera en Mexico. Hospital Luis Sanchez Bulnes
Mexico City, Mexico D. F., Mexico, 04030
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Raul Velez-Montoya, MD Asociación para Evitar la Ceguera en Mexico
Principal Investigator: Hugo Quiroz-Mercado, MD Asociación para Evitar la Ceguera en Mexico
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00563121     History of Changes
Other Study ID Numbers: ROP001
Study First Received: November 21, 2007
Last Updated: November 23, 2007
Health Authority: Mexico: Ministry of Health

Keywords provided by Asociación para Evitar la Ceguera en México:
Retinopathy of Prematurity
ROP
Vascular Endothelial Growth Factor
VEGF
Vitreous
Subretinal Fluid
ELISA
VEGF levels in Aqueous, Vitreous and subretinal Fluid

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases
Endothelial Growth Factors
Mitogens
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014