Age-related Macular DegenerationNCT01682382
Association of Macular Pigment Optical Density (MPOD) and Genetic Variants in Complement Factor H in Subjects With Choroidal Neovascular (CNV)
An observational study of Age-related Macular Degeneration and Choroidal Neovascular Age-related Macular Degeneration, run by Sequenom, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-related Macular Degeneration, Choroidal Neovascular Age-related Macular Degeneration
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Oct 2013
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- previous donation under this protocol
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Keywords
- age-related macular degeneration, choroidal neovascular age-related macular degeneration, genetics, macular pigment optical density (MPOD)
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (1)
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequenom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682382
- Sponsor's protocol ID
- SQNM-AMD-103
- Status last verified
- Jan 2014
- First submitted
- 6 Sep 2012
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- No