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Aqueous Vascular Endothelial Growth Factor (VEGF) Levels in Type 3 Neovascularization

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ClinicalTrials.gov Identifier: NCT01350323
Recruitment Status : Completed
First Posted : May 9, 2011
Last Update Posted : May 9, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Age-related Macular Degeneration Procedure: Aqueous sample

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : May 2009
Primary Completion Date : September 2010
Study Completion Date : September 2010

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Aqueous VEGF concentration [ Time Frame: Change from baseline of VEGF concentration at month 1 ]
    To establish if different types of wet-AMD were associated to different concentrations of VEGF at baseline


Secondary Outcome Measures :
  1. Macular thickness assessment [ Time Frame: Change from baseline of macular thickness at month 1 ]
    to compare central macular thickness before and after treatment respectively.


Eligibility Criteria

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Ages Eligible for Study:   55 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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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): 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:
Responsible Party: Roberto dell'Omo, University of Molise
ClinicalTrials.gov Identifier: NCT01350323     History of Changes
Other Study ID Numbers: UM-O-1
First Posted: May 9, 2011    Key Record Dates
Last Update Posted: May 9, 2011
Last Verified: March 2009

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Bevacizumab
Endothelial Growth Factors
Mitogens
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action