Genetic Load and Phenotype in Aggressive AMD
RPED Genetics
Evaluation of Genetic Variants in Patients Under Treatment for Choroidal Neovascular (CNV) Age-related Macular Degeneration (AMD), Receiving Intravitreal antiVEGF Injections to Evaluate the Association Between Genetic Load and Phenotypes Associated With More Aggressive Forms of Disease.
1 other identifier
observational
100
1 country
3
Brief Summary
Patients with AMD will provide cheek cell samples to determine if their is a correlation between genotype (DNA markers) and phenotype (the type of AMD the patient has).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2012
3 active sites
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
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 24, 2012
CompletedFirst Posted
Study publicly available on registry
July 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 20, 2014
January 1, 2014
1.4 years
July 24, 2012
January 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The identification of individual genetic markers or a quantitative measure of total genetic burden found to be significantly associated (p value <0.05) with group classification (CNV only versus CNV with GA and/or RPED).
1 day
Study Arms (2)
AMD subjects with GA and/or RPED
All subjects will have AMD and GA and/or RPED.
AMD subjects with CNV alone
All subjects will have the CNV form of AMD only.
Interventions
Eligibility Criteria
Patients with AMD who are or have been treated with anti-VEGF therapy
You may qualify if:
- Subject is male or female 50 years of age and older
- Subject provides a signed and dated informed consent
- Subject agrees to provide two buccal swabs in accordance with this protocol
- Diagnosis of CNV secondary to AMD in at least one eye
You may not qualify if:
- Previous sample donation under this protocol
- Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss such as high myopia, retinal dystrophies, central serous retinopathy, vein occlusion, diabetic retinopathy and uveitis or similar outer retinal diseases which have been present prior to the age of 50.
- Opacities of the ocular media, limitations of pupillary dilation or other problems sufficient to preclude adequate imaging of the posterior segment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sequenom, Inc.lead
Study Sites (3)
Pacific Eye Associates
San Francisco, California, 94115, United States
Retina Associates of Kentucky
Lexington, Kentucky, 40509, United States
Tennessee Retina
Nashville, Tennessee, 37203, United States
Biospecimen
DNA samples and remnants will be destroyed after analysis.
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
July 24, 2012
First Posted
July 26, 2012
Study Start
July 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 20, 2014
Record last verified: 2014-01