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Vascular Endothelial Growth Factor in Stage V ROP

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00500396
First Posted: July 12, 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
Vascular Endothelial Growth Factor (VEGF) is a dimeric glycoprotein, naturally expressed in epithelial and tumor cells (1). Normal Retinal vascularization has two phases: In the first fase, cells of mesenquimatous origin form the first superficial plexus (14-21 weeks of gestation). In the second phase, denominated "angiogenesis phase", the superficial and deep capillary plexus are formed (15,20). The Retinopathy of Prematurity (ROP) was described for the first time in 1942 (4), at the present moment it is a public health problem in the developing countries. The International Classification of ROP classifies it in 5 stages, dividing it in 3 anatomical zones. It is a public health problem that continuous without having an effective prophylaxis. The early diagnosis and treatment in thresholds stages have changed the prognosis of this disease (11,12).

Condition Intervention Phase
Retinopathy of Prematurity Procedure: Open-Sky 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 V.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • To establish a relation between the low and very low birth weight with the VEGF levels. [ Time Frame: 4 months ]
  • To prove that the VEGF level found in ROP patients is greater than in other pathologies that normally produce neovessels (like in DM). [ Time Frame: 4 months ]

Estimated Enrollment: 15
Study Start Date: March 2007
Study Completion Date: June 2007
Intervention Details:
    Procedure: Open-Sky Vitrectomy
    Open-Sky vitrectomy with removal of the Tunica vasculosa lentis and retinal reattachment
    Other Name: Vitrectomy
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months 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): NCT00500396


Locations
Mexico
Asociación para Evitar la Ceguera en Mexico
Mexico, DF, Mexico, 04030
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Hugo Quiroz-Mercado, MD Asociación para Evitar la Ceguera en México
Principal Investigator: Raul Velez-Montoya, MD Asociación para Evitar la Ceguera en Mexico
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00500396     History of Changes
Other Study ID Numbers: VEGFROP
First Submitted: July 10, 2007
First Posted: July 12, 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.

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
Mitogens
Endothelial Growth Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs