Association of Macular Pigment Optical Density (MPOD) and Genetic Variants in Complement Factor H in Subjects With Choroidal Neovascular (CNV)
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.
1 other identifier
observational
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 6, 2012
CompletedFirst Posted
Study publicly available on registry
September 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedJanuary 20, 2014
January 1, 2014
1 year
September 6, 2012
January 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Association between a genetic variant in the CFH gene and risk of progression to CNV
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
Baseline
Secondary Outcomes (1)
Genetic correlation between MPOD and risk of progression to CNV
baseline
Study Arms (3)
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)
Eligibility Criteria
Non-Hispanic Caucasian subjects 60 years of age and older diagnosed with either CNV or dry AMD and a cohort of age-matched controls
You may qualify if:
- subject is diagnosed with either CNV, dry AMD or is an age-matched control
- self reported as non-Hispanic Caucasian
- years of age or older
- provides signed and dated informed consent
- agrees to provide 10 mL of whole blood and two buccal swabs
You may not qualify if:
- previous donation under this protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sequenom, Inc.lead
Study Sites (1)
Morris Eye Group
Encinitas, California, 92024, United States
Biospecimen
DNA extracted from whole blood and buccal cells will be analyzed. Remnant samples will be stored for future research in AMD.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2012
First Posted
September 10, 2012
Study Start
August 1, 2012
Primary Completion
August 1, 2013
Study Completion
October 1, 2013
Last Updated
January 20, 2014
Record last verified: 2014-01