Aqueous Vascular Endothelial Growth Factor (VEGF) Levels in Type 3 Neovascularization - Full Text View

Purpose

This is a pilot, prospective, interventional, case-control study investigating aqueous levels of vascular endothelial growth factor (VEGF) in eyes with AMD-related neovascularization treated with intravitreal bevacizumab at the Medical Retina Department, University of Molise, Campobasso.

Condition	Intervention
Age-related Macular Degeneration	Procedure: Aqueous sample

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Aqueous Humor Levels of Vascular Endothelial Growth Factor Before and After Intravitreal Bevacizumab in Type 3 Versus Type 1 and 2 Neovascularization. A Prospective, Case-control Study.

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by University of Molise:

Primary Outcome Measures:

Aqueous VEGF concentration [ Time Frame: Change from baseline of VEGF concentration at month 1 ] [ Designated as safety issue: No ]
To establish if different types of wet-AMD were associated to different concentrations of VEGF at baseline

Secondary Outcome Measures:

Macular thickness assessment [ Time Frame: Change from baseline of macular thickness at month 1 ] [ Designated as safety issue: No ]
to compare central macular thickness before and after treatment respectively.

Enrollment:	33
Study Start Date:	May 2009
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Type 3 NV Wet-AMD related type 3 neovascularization	Procedure: Aqueous sample Aqueous sample (0.1ml of aqueous)+ intravitreal injection of bevacizumab (1.25mg/0.05ml) Other Name: Avastin
Active Comparator: Type 2 NV Wet-AMD related type 2 neovascularization	Procedure: Aqueous sample Aqueous sample (0.1ml)+intravitreal injection of bevacizumab (1.25mg/0.05ml) Other Name: Avastin
Active Comparator: Type 1 NV Wet-AMD related type 1 neovascularization	Procedure: Aqueous sample Aqueous sample (0.1ml)+ intravitreal injection of bevacizumab (1.25mg/0.05ml) Other Name: Avastin
Controls Aqueous sample (0.1ml) in patients undergoing cataract extraction	Procedure: Aqueous sample Aqueous sample (0.1ml) Other Name: Avastin

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Eligibility

Ages Eligible for Study:	55 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

wet age-related macular degeneration type 1, 2 or 3

Exclusion Criteria:

BCVA at baseline less than 1.0 logMAR
any previous treatment of the neovascular lesion
previous vitrectomy
laser coagulation within the last 3 months
previous participation in any studies using investigational drugs within 3months preceding day 0
intraocular surgery (including cataract surgery) in the study eye within 3 months preceding day 0
glaucoma in the study eye; diabetes mellitus
use of immunosuppressive drugs
malignant tumors of any location

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350323

Locations

Italy
University of Molise
Campobasso, Italy, 86100

Sponsors and Collaborators

University of Molise

Investigators

Principal Investigator:	Roberto dell'Omo, MD	University of Molise
Study Director:	Ciro Costagliola, Professor	University of Molise

More Information

Publications:

Yannuzzi LA, Negrão S, Iida T, Carvalho C, Rodriguez-Coleman H, Slakter J, Freund KB, Sorenson J, Orlock D, Borodoker N. Retinal angiomatous proliferation in age-related macular degeneration. Retina. 2001;21(5):416-34.

Bottoni F, Massacesi A, Cigada M, Viola F, Musicco I, Staurenghi G. Treatment of retinal angiomatous proliferation in age-related macular degeneration: a series of 104 cases of retinal angiomatous proliferation. Arch Ophthalmol. 2005 Dec;123(12):1644-50.

Wells JA, Murthy R, Chibber R, Nunn A, Molinatti PA, Kohner EM, Gregor ZJ. Levels of vascular endothelial growth factor are elevated in the vitreous of patients with subretinal neovascularisation. Br J Ophthalmol. 1996 Apr;80(4):363-6.

Responsible Party:	Roberto dell'Omo, University of Molise
ClinicalTrials.gov Identifier:	NCT01350323 History of Changes
Other Study ID Numbers:	UM-O-1
Study First Received:	May 2, 2011
Last Updated:	May 6, 2011
Health Authority:	Italy: Ethics Committee

Additional relevant MeSH terms:

Macular Degeneration
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Mitogens
Endothelial Growth Factors
Bevacizumab

Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013