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Protocol Details

AMD Phenotype and Genotype Study (APGS)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-EI-0027

Sponsoring Institute

National Eye Institute (NEI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 60
Max Age: 90

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Phenotype-Genotype correlation;
Phenotype;
Phenotypes;
Age Related Macular Degeneration

Recruitment Keyword(s)

None

Condition(s)

Age-Related Macular Degeneration;
AMD

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Eye Institute

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.

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Eligibility

INCLUSION CRITERIA:

1. Male or female participants with AMD in at least one eye (case) or no AMD in either eye (control).

2. Ages 60 to 90

3. Ability to provide written informed consent and comply with study assessments for the full duration of the study

4. Retinal photographs of sufficient quality to allow assessment of the macular area for AMD lesions including drusen

EXCLUSION CRITERIA:

1. Presence of lens or vitreous opacity in eye(s) with AMD to preclude adequate ophthalmic imaging

2. 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.

3. High myopia -6 Diopters or more severe

4. Diagnosis of nystagmus


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Citations:

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.

Smiddy WE, Fine SL. Prognosis of patients with bilateral macular drusen. Ophthalmology. 1984 Mar;91(3):271-7.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Wai T. Wong, M.D.
National Eye Institute (NEI)
National Institutes of Health
Building 7
Room 238
7 Center Drive
Bethesda, Maryland 20892
(301) 496-7821
wongw@mail.nih.gov

Katherine H. Shimel, R.N.
National Eye Institute (NEI)
National Institutes of Health
Building 10
Room 10S215
10 Center Drive
Bethesda, Maryland 20892
(301) 402-2863
shimelk@nei.nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01778491

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