Vascular Endothelial Growth Factor in Stage V ROP - Full Text View

Sponsored by:	Asociación para Evitar la Ceguera en México
Information provided by:	Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:	NCT00500396

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 IV

MedlinePlus related topics: Retinal Disorders

U.S. FDA Resources

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

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:

Open-Sky vitrectomy with removal of the Tunica vasculosa lentis and retinal reattachment

Show Detailed Description

Eligibility

Ages Eligible for Study:	2 Months 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: NCT00500396

Locations

Mexico, DF
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:

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.

Hurley BR. McNamara A. Fineman MS. Ho. AC. Tasman W. Kaiser RS. Vander JF. Regillo CD. Brown GC. Laser Treatment for Retinopathy of Prematurity. RETINA 26:S16-S17,2006.

[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.

Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter Trial of Cryotherapy for Retinopathy of Prematurity: ophthalmological outcomes at 10 years. Arch Ophthalmol. 2001 Aug;119(8):1110-8.

Kychenthal A, Dorta P, Katz X. Zone I retinopathy of prematurity: clinical characteristics and treatment outcomes. Retina. 2006 Sep;26(7 Suppl):S11-5.

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.

Flynn JT, Chan-Ling T. Retinopathy of prematurity: two distinct mechanisms that underlie zone 1 and zone 2 disease. Am J Ophthalmol. 2006 Jul;142(1):46-59.

Quinn GE, Schaffer DB, Johnson L. A revised classification of retinopathy of prematurity. Am J Ophthalmol. 1982 Dec;94(6):744-9.

Lermann VL, Fortes Filho JB, Procianoy RS. The prevalence of retinopathy of prematurity in very low birth weight newborn infants. J Pediatr (Rio J). 2006 Jan-Feb;82(1):27-32.

Blumenfeld LC, Siatkowski RM, Johnson RA, Feuer WJ, Flynn JT. Retinopathy of prematurity in multiple-gestation pregnancies. Am J Ophthalmol. 1998 Feb;125(2):197-203.

Early Treatment For Retinopathy Of Prematurity Cooperative Group. Revised indications for the treatment of retinopathy of prematurity: results of the early treatment for retinopathy of prematurity randomized trial. Arch Ophthalmol. 2003 Dec;121(12):1684-94.

Kieselbach GF, Ramharter A, Baldissera I, Kralinger MT. Laser photocoagulation for retinopathy of prematurity: structural and functional outcome. Acta Ophthalmol Scand. 2006 Feb;84(1):21-6.

Chowers I, Banin E, Hemo Y, Porat R, Falk H, Keshet E, Pe'er J, Panet A. Gene transfer by viral vectors into blood vessels in a rat model of retinopathy of prematurity. Br J Ophthalmol. 2001 Aug;85(8):991-5.

Study ID Numbers:	VEGFROP
Study First Received:	July 10, 2007
Last Updated:	November 21, 2007
ClinicalTrials.gov Identifier:	NCT00500396
Health Authority:	Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Asociación para Evitar la Ceguera en México:

Retinopathy of Prematurity.
ROP.
Vascular Endothelial Growth Factor.
VEGF.

Vitreous.
Subretinal Fluid.
ELISA.

Study placed in the following topic categories:

Eye Diseases
Retinopathy of prematurity
Infant, Newborn, Diseases
Infant, Premature, Diseases

Retinopathy of Prematurity
Endothelial Growth Factors
Retinal Diseases

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009