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

NCT00563121 | Withdrawn Phase 4 DMC

• 1 other identifier: ROP001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Retinopathy of Prematurity

Keywords

Retinopathy of Prematurity; ROP; Vascular Endothelial Growth Factor; VEGF; Vitreous; Subretinal Fluid; ELISA; VEGF levels in Aqueous, Vitreous and subretinal Fluid

Outcome Measures

Primary Outcomes (1)

• VEGF Levels

  one day

Interventions

Vitrectomy PROCEDURE

Open-Sky vitrectomy, with resection of the tunica vasculosa lentis, and retinal reattachment

Eligibility Criteria

• Age: 1 Month - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead

Study Sites (2)

Asociación para Evitar la Ceguera en Mexico

Mexico City, Mexico City, 04030, Mexico

Location

Asociacion Para Evitar la Ceguera en Mexico. Hospital Luis Sanchez Bulnes

Mexico City, Mexico D. F., 04030, Mexico

Location

Related Publications (11)

• 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. doi: 10.1016/S0002-9440(10)65004-3.

  PMID: 10751359 BACKGROUND

• 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. doi: 10.1001/archopht.1996.01100140419009.

  PMID: 8859081 BACKGROUND

• 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. doi: 10.1097/01.iae.0000244292.86627.1e.

  PMID: 16946672 BACKGROUND

• 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. doi: 10.1073/pnas.101113998. Epub 2001 May 1.

  PMID: 11331770 BACKGROUND

• 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. doi: 10.1167/iovs.05-1046.

  PMID: 16431975 BACKGROUND

• Cooke RW, Drury JA, Mountford R, Clark D. Genetic polymorphisms and retinopathy of prematurity. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1712-5. doi: 10.1167/iovs.03-1303.

  PMID: 15161830 BACKGROUND

• 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.

  PMID: 17093399 BACKGROUND

• Phelps DL; ETROP Cooperative Group. The Early Treatment for Retinopathy of Prematurity study: better outcomes, changing strategy. Pediatrics. 2004 Aug;114(2):490-1. doi: 10.1542/peds.114.2.490. No abstract available.

  PMID: 15286235 BACKGROUND

• 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. doi: 10.1167/iovs.05-0376.

  PMID: 16303979 BACKGROUND

• 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. doi: 10.1001/archopht.1988.01060130517027.

  PMID: 2895630 BACKGROUND

• 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. doi: 10.1016/j.ophtha.2004.03.035.

  PMID: 15465550 BACKGROUND

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Raul Velez-Montoya, MD

  Asociación para Evitar la Ceguera en Mexico

  PRINCIPAL INVESTIGATOR

• Hugo Quiroz-Mercado, MD

  Asociación para Evitar la Ceguera en Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 26, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2007
• Study Completion: June 1, 2007
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

ME (2)