AMD Phenotype and Genotype Study
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Purpose
Background:
- Age-related macular degeneration (AMD) is a disease that blurs the sharp vision needed for activities such as reading, sewing, and driving. It affects the macula, the center of the retina at the back of the eye, which allows a person to see fine detail. Researchers want to collect medical histories, eye exam data, and genetic information that may be associated with AMD. They want to compare this information with information collected from people without AMD.
Objectives:
- To collect medical information and gene samples for researchers studying AMD.
Eligibility:
- Individuals between and 60 and 90 years of age who have AMD in at least one eye.
- Individuals between and 60 and 90 years of age who have no AMD in either eye.
Design:
- This study will involve one study visit. This study visit will last 6 to 8 hours.
- Participants will have the following tests and exams as part of their study visit:
- Full physical exam and medical history
- Full eye examination
- Laser scan of the eye
- Retina function test
- Vision sensitivity test
- Optional blood sample (for genetic study)
- No treatment will be provided as part of this study.
| Condition |
|---|
|
Age-Related Macular Degeneration AMD |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | AMD Phenotype and Genotype Study (APGS) |
- Allow users to assess phenotypes of AMD [ Time Frame: 5 years ]
- Develop and evaluate potential markers and risk [ Time Frame: 5 years ]
- Develop and evaluate an AMD classification scheme(s) [ Time Frame: 5 years ]
- Assess the progression of the disease and investigate that shape it. [ Time Frame: 5 years ]
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
Objective: Late age-related macular degeneration (AMD) is the leading cause of blindness among elderly in the United States.1 At present the current classification systems do not take into consideration advances in imaging technology and genotyping phenotyping. Clinical centers in the US and around the world will conduct a cohort study that will bring together resources and commitment to develop a new classification scheme for AMD using imaging, genetic and visual function biomarkers. These data will also provide resources for understanding the development and progression of AMD. A database of men and women with and without AMD will be established and maintained. The project will recruit participants who have various stages of AMD and controls. All data, images and biospecimens will be available to researchers worldwide to help in the development of biomarker identification and classification development. The initiative should provide an unparalleled state-of-the-art standardized phenotype/genotype including AMD status with information on imaging, visual function, and biospecimen biomarkers. This study is the first phase of this initiative to test the feasibility and logistics of defining a standard database including enhanced phenotype and genotype data.
Study Population: This cohort study will recruit approximately 100 - 200 participants with various stages of AMD, including controls and obtain the appropriate images, measures of visual function and biospecimens needed for the investigation and validation of an AMD phenotype.
Design: This cohort study is a multi-national, multi-center, observational study focused on AMD. The study is a pilot to test the ability to create an archive of data, biological samples, measures of visual function and ophthalmic images collected over time from a very well clinically characterized population of participants with a diagnosis of AMD. The database will also include a control group consisting of participants without a diagnosis of AMD.
Outcome Measures: The design of this cohort study and the data being collected will allow users to assess phenotypes of AMD, develop and evaluate potential markers and risk factors, develop and evaluate an AMD classification scheme(s), and assess the progression of the disease and investigate factors that shape it. It is not practical to anticipate all of the potential uses of the data, or all the types of analyses that will be performed to address user-defined questions.
Eligibility| Ages Eligible for Study: | 60 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA:
- Male or female participants with AMD in at least one eye (case) or no AMD in either eye (control).
- Ages 60 to 90
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Retinal photographs of sufficient quality to allow assessment of the macular area for AMD lesions including drusen
EXCLUSION CRITERIA:
- Presence of lens or vitreous opacity in eye(s) with AMD to preclude adequate ophthalmic imaging
- Presence of ocular conditions that may now or in the future complicate the evaluation of AMD; e.g., vascular occlusion, diabetic retinopathy (less than 4 microaneurysms), etc., in the eye(s) with AMD.
- High myopia -6 Diopters or more severe
- Diagnosis of nystagmus
Contacts and Locations| Contact: Katherine H Shimel, R.N. | (301) 402-2863 | shimelk@nei.nih.gov |
| Contact: Wai T Wong, M.D. | (301) 496-7821 | wongw@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | Wai T Wong, M.D. | National Eye Institute (NEI) |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ) |
| ClinicalTrials.gov Identifier: | NCT01778491 History of Changes |
| Other Study ID Numbers: | 130027, 13-EI-0027 |
| Study First Received: | January 26, 2013 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Phenotype-Genotype correlation Phenotype Phenotypes Age Related Macular Degeneration |
Additional relevant MeSH terms:
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013