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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

Tracking Information
First Submitted Date December 1, 2009
First Posted Date December 2, 2009
Last Update Posted Date December 2, 2009
Study Start Date January 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: December 1, 2009)
mfERG central ring amplitude density [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 1, 2009)
  • Mean retinal sensitivity (dB) in three concentric rings (4°, 8° & 12°) [ Time Frame: 12 months ]
  • Choroidal blood flow (ChBFlow) at fovea and at optic nerve head [ Time Frame: 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Macular Function During Anti-VEGF Treatment
Official Title Study of Macular Function During Anti-VEGF Treatment
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.
Detailed Description Macular function will be investigated using visual acuity, contrast sensitivity, mfERG and microperimetry.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population AMD clinic
Condition Age Related Macular Degeneration
Intervention Not Provided
Study Groups/Cohorts
  • Group A
    Patients investigated with mfERG and MP-1
  • Group B
    Patients investigated by Laser Doppler Flowmetry
Publications * Campa C, Hagan R, Sahni JN, Brown MC, Beare NA, Heimann H, Harding SP. Early multifocal electroretinogram findings during intravitreal ranibizumab treatment for neovascular age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Jun 1;52(6):3446-51. doi: 10.1167/iovs.10-6588.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 1, 2009)
40
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01023971
Other Study ID Numbers Trust R&D_3704
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Simon P Harding, Royal Liverpool University Hospital
Study Sponsor Royal Liverpool University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Simon P HARDING, FRCOphth, MD University of Liverpool
PRS Account Royal Liverpool University Hospital
Verification Date December 2009