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Home > "G" Clinical Trials Conditions > Genetic Factors in Age-Related Macular Degeneration  Genetic Factors in Age-Related Macular Degeneration
Genetic Factors in Age-Related Macular Degeneration
For Condition: Macular Degeneration
Status: Recruiting
Sponsor(s): National Eye Institute (NEI) ,
Synopsis: This study will examine whether certain polymorphisms (small gene variances) predispose people to develop age-related macular degeneration (AMD). This eye condition affects people over 50 years of age and can cause permanent loss of central vision. The study will examine and compare the frequency of polymorphisms in patients with AMD to that of individuals without AMD. This information will help identify genetic risk factors for the AMD and may lead to the development of more effective treatments. Patients 50 years of age and older with advanced AMD and healthy normal volunteers may be eligible for this study. All participants will provide an eye health history and will have 10 milliliters (2 teaspoons) of blood drawn from an arm vein. The DNA in the blood will be isolated and tested for certain genes that other research indicates are important in aging and age-related diseases. The normal and polymorphic gene sequences will be identified and compared in patients with AMD and control subjects to determine if any of the polymorphisms are related to development of AMD. In addition, control subjects will have a routine eye examination, including dilation of the pupils for examination of the back of the eye.
Details: Age-related macular degeneration (AMD) is the leading cause of irreversible severe central visual loss in Caucasians older than 50 in the U.S. The incidence and progression of all the features of AMD are known to increase significantly with age. Approximately 10% of people 66 to 74 years of age will have findings of AMD, and the prevalence increases to approximately 30% in people 75 to 85 years of age. Recently in a large study with three racially similar populations of 14,752 participants from North America, Europe, and Australia, the prevalence of AMD is present in 0.2% of the combined population aged 55 to 64 years, rising to 13% of the population older than 85 years. Epidemiological studies of candidate gene association and linkage disequilibrium suggest that AMD has a significant genetic component. Current evidence supports the hypothesis that variance of genes involved in DNA repair, oxidative stress, and inflammation play a role in aging and age-related diseases. Recently a few studies have documented the association between polymorphisms in oxidative stress, apolipoprotein E (ApoE), and angiotensin converting enzyme (ACE) genes and AMD. Single nucleotide polymorphism (SNP) in ApoE and ACE may protect AMD. On the other hand, SNP in manganese superoxide dismutate (oxidative stress) gene may be related to exudative AMD. In this study, we would like to test whether the variations of biologically plausible genes (or the modifying genes) listed above are differentially distributed in AMD patients and normal populations. To this end, we choose genes that are believed to play a crucial role in aging process and will analyze the frequency of SNPs specifically within the coding frames of biologically plausible genes responsible for aging and age-related disease. Our aim will be to compare the allelic frequencies of candidate genes listed above in cohorts with AMD to the frequency in normal control subjects without AMD. With this study we hope to identify genetic risk factors that could have functional implications for understanding and treating AMD.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Samples from volunteers meeting the following eligibility criteria will be included in the study. AMD Patients (cases): Diagnosis of advanced AMD defined by geographic atrophy and/or choroidal neovascularization with drusen of any size in at least one eye. (AMD cases only) Age 50 years or older. If sample previously donated in a different study, the patient has given their permission to use their sample (i.e. marked appropriate selection in the informed consent). Control Patients (controls): Absence of drusen or no more than 5 drusen less than 63 microns, absence of other of diagnostic criteria for AMD. Agrees to undergo study examinations. EXCLUSION CITERIA: Samples from volunteers meeting any of the following exclusion criteria will not be included. 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 that have been present prior to the age of 50. Opacities of the ocular media, limitations of papillary dilation or other problems sufficient to preclude adequate stereo fundus photography. These conditions include occluded pupils due to synechiae, cataracts, vitreous haze and opacities due to ocular diseases.
Total Enrollment: 350
Location and Contact Information:
National Eye Institute (NEI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030155; 03-EI-0155
Study Start Date: April 4, 2003
Record last reviewed: March 8, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058695
Other Macular Degeneration Studies:
1. Fluocinolone Implant to Treat Macular Degeneration
2. Macular Photocoagulation Study (MPS)
3. Randomized Trial of Beta-Carotene and Macular Degeneration
4. Preventing Depression in Patients with Macular Degeneration
5. Diabetic Retinopathy and Visual Function Study
Related Studies:
Other Macular Degeneration Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Genetic Factors in Age-Related Macular Degeneration
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