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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00563121
First Posted: November 26, 2007
Last Update Posted: November 26, 2007
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
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: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 10 Years   (Child)
Sexes Eligible for Study:   All
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
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): 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
First Submitted: November 21, 2007
First Posted: November 26, 2007
Last Update Posted: November 26, 2007
Last Verified: November 2007

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
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs