Age-Related Macular Degeneration Clinical Trial
Official title:
AMD Phenotype and Genotype Study (APGS)
Verified date | September 29, 2015 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 344 |
Est. completion date | September 29, 2015 |
Est. primary completion date | September 29, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 90 Years |
Eligibility |
- INCLUSION CRITERIA: To be eligible, the following inclusion criteria must be met, where applicable. -Male or female participants must fall into any of the following categories: - No drusen or any AMD-associated pigment abnormalities (no apparent aging changes) - Small drusen (less than or equal to 63 micro millimeters in diameter) and the absence of AMD-associated pigment abnormalities in either eye (normal aging changes) - Medium (>63 (Micro)m and less than or equal to 125 micro millimeters in diameter) drusen in either eye (Early AMD) - Large (>125 (Micro)m in diameter) drusen with or without pigmentary abnormalities in either eye (Intermediate AMD) - Neovascular AMD in only one eye or the presence of geographic atrophy in either eye but with vision >20/60 in the better-seeing eye (Late AMD) - Presence of reticular Drusen in either eye AMD classification will be based on clinical evaluation. - 60 years of age or older - 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: A participant is not eligible if any of the following exclusion criteria are present: - 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 (>4 microaneurysms), etc.] in the eye(s) with AMD - High myopia -6 Diopters or more severe - Diagnosis of nystagmus - Glaucoma with definite visual field defects. Participants with a history of the diagnosis of glaucoma, past or present use of medications to control intraocular pressure, or disc/nerve fiber layer defects suggestive of glaucoma can be eligible for the study if they have a documented normal Goldmann, Humphrey, or Octopus perimetry test within 6 months prior to qualification. |
Country | Name | City | State |
---|---|---|---|
Germany | University of Bonn | Bonn | |
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Eye Institute (NEI) |
United States, Germany,
Kini MM, Leibowitz HM, Colton T, Nickerson RJ, Ganley J, Dawber TR. Prevalence of senile cataract, diabetic retinopathy, senile macular degeneration, and open-angle glaucoma in the Framingham eye study. Am J Ophthalmol. 1978 Jan;85(1):28-34. — View Citation
Smiddy WE, Fine SL. Prognosis of patients with bilateral macular drusen. Ophthalmology. 1984 Mar;91(3):271-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Allow users to assess phenotypes of AMD | 5 years | ||
Primary | Develop and evaluate potential markers and risk | 5 years | ||
Primary | Develop and evaluate an AMD classification scheme(s) | 5 years | ||
Primary | Assess the progression of the disease and investigate that shape it. | 5 years |
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