VEGF Levels in Aqueous, Vitreous and Subretinal Fluid in ROP Stage IV and V - Full Text View

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:

MedlinePlus related topics: Premature Babies Retinal Disorders

U.S. FDA Resources

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:

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

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:

Lashkari K, Hirose T, Yazdany J, McMeel JW, Kazlauskas A, Rahimi N. Vascular endothelial growth factor and hepatocyte growth factor levels are differentially elevated in patients with advanced retinopathy of prematurity. Am J Pathol. 2000 Apr;156(4):1337-44.

Pierce EA, Foley ED, Smith LE. Regulation of vascular endothelial growth factor by oxygen in a model of retinopathy of prematurity. Arch Ophthalmol. 1996 Oct;114(10):1219-28. Erratum in: Arch Ophthalmol 1997 Mar;115(3):427.

Gaynon MW. Rethinking STOP-ROP: is it worthwhile trying to modulate excessive VEGF levels in prethreshold ROP eyes by systemic intervention? A review of the role of oxygen, light adaptation state, and anemia in prethreshold ROP. Retina. 2006 Sep;26(7 Suppl):S18-23. Review.

Hellstrom A, Perruzzi C, Ju M, Engstrom E, Hard AL, Liu JL, Albertsson-Wikland K, Carlsson B, Niklasson A, Sjodell L, LeRoith D, Senger DR, Smith LE. Low IGF-I suppresses VEGF-survival signaling in retinal endothelial cells: direct correlation with clinical retinopathy of prematurity. Proc Natl Acad Sci U S A. 2001 May 8;98(10):5804-8. Epub 2001 May 1.

Modanlou HD, Gharraee Z, Hasan J, Waltzman J, Nageotte S, Beharry KD. Ontogeny of VEGF, IGF-I, and GH in neonatal rat serum, vitreous fluid, and retina from birth to weaning. Invest Ophthalmol Vis Sci. 2006 Feb;47(2):738-44.

Cooke RW, Drury JA, Mountford R, Clark D. Genetic polymorphisms and retinopathy of prematurity. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1712-5.

Maier R, Weger M, Haller-Schober EM, El-Shabrawi Y, Theisl A, Barth A, Aigner R, Haas A. Application of multiplex cytometric bead array technology for the measurement of angiogenic factors in the vitreous. Mol Vis. 2006 Oct 2;12:1143-7.

Phelps DL; ETROP Cooperative Group. The Early Treatment for Retinopathy of Prematurity study: better outcomes, changing strategy. Pediatrics. 2004 Aug;114(2):490-1. No abstract available.

Yoo MH, Hyun HJ, Koh JY, Yoon YH. Riluzole inhibits VEGF-induced endothelial cell proliferation in vitro and hyperoxia-induced abnormal vessel formation in vivo. Invest Ophthalmol Vis Sci. 2005 Dec;46(12):4780-7.

[No authors listed] Multicenter trial of cryotherapy for retinopathy of prematurity. Preliminary results. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1988 Apr;106(4):471-9.

Itakura H, Kishi S, Kotajima N, Murakami M. Persistent secretion of vascular endothelial growth factor into the vitreous cavity in proliferative diabetic retinopathy after vitrectomy. Ophthalmology. 2004 Oct;111(10):1880-4.

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, Premature, Diseases
Infant, Newborn, Diseases
Mitogens

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

ClinicalTrials.gov processed this record on May 19, 2013