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Association of Macular Pigment Optical Density (MPOD) and Genetic Variants in Complement Factor H in Subjects With Choroidal Neovascular (CNV)

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ClinicalTrials.gov Identifier: NCT01682382
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : January 20, 2014
Sponsor:
Information provided by (Responsible Party):
Sequenom, Inc.

Study Description
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Brief Summary:
Subjects with wet AMD, dry AMD, and age-matched controls will undergo routine occular measurements, will provide a blood and cheek cell sample, and will have macular pigment optical density (MPOD) measured to determine if there is an association between genetics, MPOD and the risk of progression to wet AMD.

Condition or disease
Age-related Macular Degeneration Choroidal Neovascular Age-related Macular Degeneration

Study Design
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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection of Whole Blood Specimens and Buccal Swabs From Subjects Diagnosed With CNV AMD, Dry AMD, and Age-Matched Controls to Assess the Association of Genetic Variants in Complement Factor H With Risk of Progression to CNV.
Study Start Date : August 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : October 2013

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Groups and Cohorts
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Group/Cohort
choroidal neovascular (CNV) AMD subjects
Subjects diagnosed with CNV (AREDS Grade 4b)
dry AMD subjects
Subjects diagnosed with dry AMD (AREDS Grade 3)
age-matched controls
Subjects without AMD (AREDS Grade 1)


Outcome Measures
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Primary Outcome Measures :
  1. Association between a genetic variant in the CFH gene and risk of progression to CNV [ Time Frame: Baseline ]
    DNA extracted from blood and buccal cells collected from subjects with either CNV, dry AMD, and age-matched controls will be analyzed to investigate a genetic variant in the CFH gene and its association with risk of progression to CNV


Secondary Outcome Measures :
  1. Genetic correlation between MPOD and risk of progression to CNV [ Time Frame: baseline ]
    DNA extracted from blood and buccal cells collected from subjects with either CNV, dry AMD, and age-matched controls will be analyzed to investigate the correlation between genetics, MPOD, and risk of progression to CNV


Biospecimen Retention:   Samples With DNA
DNA extracted from whole blood and buccal cells will be analyzed. Remnant samples will be stored for future research in AMD.

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Non-Hispanic Caucasian subjects 60 years of age and older diagnosed with either CNV or dry AMD and a cohort of age-matched controls
Criteria

Inclusion Criteria:

  • subject is diagnosed with either CNV, dry AMD or is an age-matched control
  • self reported as non-Hispanic Caucasian
  • 60 years of age or older
  • provides signed and dated informed consent
  • agrees to provide 10 mL of whole blood and two buccal swabs

Exclusion Criteria:

  • previous donation under this protocol
Contacts and Locations
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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): NCT01682382


Locations
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United States, California
Morris Eye Group
Encinitas, California, United States, 92024
Sponsors and Collaborators
Sequenom, Inc.
More Information
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Responsible Party: Sequenom, Inc.
ClinicalTrials.gov Identifier: NCT01682382     History of Changes
Other Study ID Numbers: SQNM-AMD-103
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: January 20, 2014
Last Verified: January 2014

Keywords provided by Sequenom, Inc.:
age-related macular degeneration
choroidal neovascular age-related macular degeneration
genetics
macular pigment optical density (MPOD)

Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Complement System Proteins
 Complement Factor H
Immunologic Factors
Physiological Effects of Drugs
Complement Inactivating Agents
Immunosuppressive Agents