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

This study has been completed.
Sponsor:
Information provided by:
University of Molise
ClinicalTrials.gov Identifier:
NCT01350323
First received: May 2, 2011
Last updated: May 6, 2011
Last verified: March 2009
  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:


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

  Show Detailed Description

  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
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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:
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 July 24, 2014