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

Age-related Macular Degeneration Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682382
• Other study ID #: SQNM-AMD-103
• Status: Completed
• Phase: N/A
• First received: September 6, 2012
• Last updated: January 16, 2014
• Start date: August 2012
• Est. completion date: October 2013

Study information

• Verified date: January 2014
• Source: Sequenom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: IRB approved
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Choroidal Neovascular Age-related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Locations

Country	Name	City	State
United States	Morris Eye Group	Encinitas	California

Sponsors (1)

Lead Sponsor	Collaborator
Sequenom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Genetic correlation between MPOD 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 the correlation between genetics, MPOD, and risk of progression to CNV	baseline	No