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Age-Related Macular DegenerationNCT01778491

AMD Phenotype and Genotype Study

An observational study of Age-Related Macular Degeneration and AMD, run by National Eye Institute (NEI) at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 to 90 years
Conditions the study is for
Age-Related Macular Degeneration, AMD
How many people
344 participants
Where
2 sitesin 2 countries
Study dates
5 Nov 2012to 29 Sep 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

Germany1 site

  • University of Bonn

    Bonn

Other trials in Germany

About this study

Official title: AMD Phenotype and Genotype Study (APGS)

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.
Read more

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.
Read the detailed description

Objective: Late age-related macular degeneration (AMD) is the leading cause of blindness among elderly in the United States. At present the current classification systems do not take into consideration advances in imaging technology and genotyping and phenotyping.

Clinical centers in the US and around the world will conduct a pilot cohort study that will bring together resources and commitment to test the feasibility of developing a new classification scheme for AMD using imaging and visual function biomarkers, with the potential of correlating genetic information obtained in the future. These data could eventually help develop an understanding of the mechanisms involved in 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. The pilot study will identify the feasibility of obtaining imaging and visual function data and help identify which of these modalities should be included in a full scale longitudinal study, as well as how frequently and at which sites they should be obtained. All data, images and any potential biospecimens from the full scale longitudinal study 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 a minimum of 200 total participants with various stages of AMD, including controls and obtain the appropriate images and measures of visual function 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 (collected at other study sites), 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.

Keywords
Phenotype-Genotype correlation, Phenotype, Phenotypes, Age Related Macular Degeneration
Medical subject headings
Macular Degeneration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Allow users to assess phenotypes of AMD

    Measured: 5 years

  2. Develop and evaluate potential markers and risk

    Measured: 5 years

  3. Develop and evaluate an AMD classification scheme(s)

    Measured: 5 years

  4. Assess the progression of the disease and investigate that shape it.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2013 (estimated)
  2. Study start5 Nov 2012
  3. Primary completion29 Sep 2015
  4. Study completion29 Sep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01778491
Sponsor's protocol ID
130027
Other IDs
13-EI-0027
Status last verified
29 Sep 2015
First submitted
26 Jan 2013
Last updated
5 Apr 2018
Results posted
No

Publications

  • 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. doi: 10.1016/s0002-9394(14)76661-9.

    PubMed 619683

  • Smiddy WE, Fine SL. Prognosis of patients with bilateral macular drusen. Ophthalmology. 1984 Mar;91(3):271-7. doi: 10.1016/s0161-6420(84)34309-3.

    PubMed 6201789

Questions about this trial

What is this clinical trial studying?

An observational study of Age-Related Macular Degeneration and AMD, run by National Eye Institute (NEI) at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Allow users to assess phenotypes of AMD (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01778491, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.

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