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Macular Function During Anti-VEGF Treatment (MAFAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01023971
Recruitment Status : Unknown
Verified December 2009 by Royal Liverpool University Hospital.
Recruitment status was:  Recruiting
First Posted : December 2, 2009
Last Update Posted : December 2, 2009
Sponsor:
Information provided by:
Royal Liverpool University Hospital

Brief Summary:
The purpose of this study is to determine the changes in macular function during anti-VEGF treatment for neovascular age-related macular degeneration.

Condition or disease
Age Related Macular Degeneration

Detailed Description:
Macular function will be investigated using visual acuity, contrast sensitivity, mfERG and microperimetry.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Macular Function During Anti-VEGF Treatment
Study Start Date : January 2009

Resource links provided by the National Library of Medicine


Group/Cohort
Group A
Patients investigated with mfERG and MP-1
Group B
Patients investigated by Laser Doppler Flowmetry



Primary Outcome Measures :
  1. mfERG central ring amplitude density [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Mean retinal sensitivity (dB) in three concentric rings (4°, 8° & 12°) [ Time Frame: 12 months ]
  2. Choroidal blood flow (ChBFlow) at fovea and at optic nerve head [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
AMD clinic
Criteria

Inclusion Criteria:

  • Neovascular AMD in first or second eyes
  • angiographic signs of active subfoveal or juxtafoveal choroidal neovascularization (CNV)
  • BCVA ≥35 ETDRS letters

Exclusion Criteria:

  • Spherical equivalent ≥ ± 6 D
  • Previous treatments for CNV in the studied eye

Information from the National Library of Medicine

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): NCT01023971


Contacts
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Contact: Simon P Harding, FRCOphth, MD +44 0151 706 ext 3966 S.P.Harding@liverpool.ac.uk
Contact: Claudio S Campa, MD, PhD +44 0151 706 ext 3939 Claudio.Campa@rlbuht.nhs.uk

Locations
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United Kingdom
Clinical Eye Research Centre Recruiting
Liverpool, United Kingdom, L7 8XP
Contact: Simon P HARDING, FRCOphth, MD       S.P.Harding@liverpool.ac.uk   
Principal Investigator: SIMON P HARDING, FRCOphth, MD         
Sub-Investigator: CLAUDIO S CAMPA, MD,PhD         
Sponsors and Collaborators
Royal Liverpool University Hospital
Investigators
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Principal Investigator: Simon P HARDING, FRCOphth, MD University of Liverpool

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Simon P Harding, Royal Liverpool University Hospital
ClinicalTrials.gov Identifier: NCT01023971     History of Changes
Other Study ID Numbers: Trust R&D_3704
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors