AMDNCT01915238
Study of the Effects of Supplements on Eye Disease in Participants From the Age-Related Eye Disease Study
An observational study of AMD and Age- Related Macular Degeneration, run by National Eye Institute (NEI) at 2 sites in United States.
Trial summary
Background: The Age-Related Eye Disease 2 Study (AREDS2) looked at two eye diseases. These were age-related macular degeneration (AMD) and cataracts. Participants in that study took supplement pills and some participants had additional pictures taken of their eyes. That study is now over. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- AMD, Age- Related Macular Degeneration
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jul 2013to 20 Jun 2014
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be eligible if they:
- Were enrolled in the AREDS2 protocol and successfully completed the final AREDS2 follow-up visit.
- Can understand and provide informed consent.
Who cannot join
- Participants will not be eligible if they:
- 1. Are not able to return to NIH for examination for follow up visits.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Duke Univiversity Eye Center
Durham, North Carolina
About this study
Official title: Age-Related Eye Disease Study 2 (AREDS2) Ancillary Spectral Domain Optical Coherence Tomography (A2A_SDOCT) Extension Study
Background:
- The Age-Related Eye Disease 2 Study (AREDS2) looked at two eye diseases. These were age-related macular degeneration (AMD) and cataracts. Participants in that study took supplement pills and some participants had additional pictures taken of their eyes. That study is now over. Researchers want to do a follow-up study after participants finish taking the pills, to see if they cause long-term effects on AMD. This study will be combined with follow-up visits of the AREDS2 study if possible.
Read more
Objectives:
- To learn more about the effect of oral supplements on AMD.
Eligibility:
- People who completed the AREDS2 study.
Design:
- Participants will have up to 2 study visits over 6 18 months.
- Each visit will last up to 5 hours. The visits will be combined with annual follow-up visits in the AREDS2 study if possible.
- At each visit, participants will undergo an eye exam and photography.
- The eye exam includes testing sight, measuring eye pressure, and checking eye movements. To examine the inside of the eye, the pupil will be dilated with eye drops.
- Photographs of the inside of the eye may be taken during the eye exam and while the eyes are dilated.
- A contact lens may be placed on the eye briefly to look at the retina at the back of the eye.
Read the detailed description
The Age Related Eye Disease Study 2 (AREDS2) was a multicenter Phase III randomized clinical trial designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and/or omega-3 LCPUFAs as a treatment for age-related macular degeneration (AMD), cataract and moderate vision loss. In addition to this objective, the study provided information on the clinical course, prognosis, and risk factors for development and progression of both AMD and cataract. Other study goals included the evaluation of eliminating beta-carotene and/or reducing zinc in the original AREDS formulation on the progression and development of AMD. AREDS2 also sought to validate the fundus photographic AMD scale developed from AREDS.
Inclusion criteria in AREDS2 resulted in the enrollment of participants with intermediate AMD, defined by the presence of large drusen, with and without additional pigmentary changes. Owing to the longitudinal nature of AREDS2 study, anatomical features of AMD in study participants can be monitored and characterized as a function of time to further understand the steps in AMD progression. Spectral domain OCT (SDOCT) is a non-invasive imaging technology that has the speed and resolution to image fine structures such as drusen and the photoreceptor layers. With annotation and processing of three-dimensional SDOCT scans, focal AMD pathology such as drusen can be mapped and monitored over time. The AREDS2 Ancillary SDOCT Study (A2A SDOCT) added the use of novel higher resolution three-dimensional OCT retinal imaging at four AREDS2 study centers to examine 400 of the participants in the AREDS2 clinical trial.
The purpose of this ancillary AREDS2 study (study acronym: A2A_SDOCT) is to identify whether measurable AMD pathology (drusen, photoreceptor layer thickness, early findings of geographic atrophy (GA) or neovascularization) imaged by spectral domain optical coherence tomography (SDOCT) can predict progression of AMD and vision loss. The A2A_SDOCT study began as an ancillary AREDS2 study; however AREDS2 had stopped gathering participant data on October 31, 2012 and will be terminated soon. This extension study is needed to complete the AREDS2 dataset by collecting images at one or two additional time points, as the study started over a year behind the AREDS2 study. The data collection period for the extension will end April 30, 2014. Data analysis will conclude by October 31, 2014. All AREDS2 study procedure guidelines for data collection will be followed, as described below, even though this visit falls outside the AREDS2 study timeline.
- Conditions
- AMD, Age- Related Macular Degeneration
- Keywords
- Age-Related Macular Degeneration (AMD), AMD
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision loss outcome measure is mean change in visual acuity by Early Treatment Diabetic Retinopathy (ETDRS) score.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study start16 Jul 2013
- Primary completion20 Jun 2014
- Study completion20 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Wai T Wong, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915238
- Sponsor's protocol ID
- 130179
- Other IDs
- 13-EI-0179
- Status last verified
- 20 Jun 2014
- First submitted
- 31 Jul 2013
- Last updated
- 30 Aug 2017
- Results posted
- No
Publications
AREDS2 Research Group; Chew EY, Clemons T, SanGiovanni JP, Danis R, Domalpally A, McBee W, Sperduto R, Ferris FL. The Age-Related Eye Disease Study 2 (AREDS2): study design and baseline characteristics (AREDS2 report number 1). Ophthalmology. 2012 Nov;119(11):2282-9. doi: 10.1016/j.ophtha.2012.05.027. Epub 2012 Jul 26.
PubMed 22840421Age-Related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. JAMA. 2013 May 15;309(19):2005-15. doi: 10.1001/jama.2013.4997.
PubMed 23644932
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Related Eye Disease Study 2 (AREDS2) Ancillary Spectral Domain Optical Coherence Tomography (A2A_SDOCT) Extension Study
- ClinicalTrials.gov ID
- NCT01915238
- Acronym / sponsor ID
- 130179
- Conditions
- AMD, Age- Related Macular Degeneration
- Keywords
- Age-Related Macular Degeneration (AMD), AMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 16 Jul 2013
- Primary completion
- 20 Jun 2014 (actual)
- Study completion
- 20 Jun 2014 (actual)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- The Age-Related Eye Disease 2 Study (AREDS2) looked at two eye diseases. These were age-related macular degeneration (AMD) and cataracts. Participants in that study took supplement pills and some participants had additional pictures taken of their eyes. That study is now over. Researchers want to do a follow-up study after participants finish taking the pills, to see if they cause long-term effects on AMD. This study will be combined with follow-up visits of the AREDS2 study if possible.
Objectives:
- To learn more about the effect of oral supplements on AMD.
Eligibility:
- People who completed the AREDS2 study.
Design:
- Participants will have up to 2 study visits over 6 18 months.
- Each visit will last up to 5 hours. The visits will be combined with annual follow-up visits in the AREDS2 study if possible.
- At each visit, participants will undergo an eye exam and photography.
- The eye exam includes testing sight, measuring eye pressure, and checking eye movements. To examine the inside of the eye, the pupil will be dilated with eye drops.
- Photographs of the inside of the eye may be taken during the eye exam and while the eyes are dilated.
- A contact lens may be placed on the eye briefly to look at the retina at the back of the eye.
Detailed description
The Age Related Eye Disease Study 2 (AREDS2) was a multicenter Phase III randomized clinical trial designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and/or omega-3 LCPUFAs as a treatment for age-related macular degeneration (AMD), cataract and moderate vision loss. In addition to this objective, the study provided information on the clinical course, prognosis, and risk factors for development and progression of both AMD and cataract. Other study goals included the evaluation of eliminating beta-carotene and/or reducing zinc in the original AREDS formulation on the progression and development of AMD. AREDS2 also sought to validate the fundus photographic AMD scale developed from AREDS.
Inclusion criteria in AREDS2 resulted in the enrollment of participants with intermediate AMD, defined by the presence of large drusen, with and without additional pigmentary changes. Owing to the longitudinal nature of AREDS2 study, anatomical features of AMD in study participants can be monitored and characterized as a function of time to further understand the steps in AMD progression. Spectral domain OCT (SDOCT) is a non-invasive imaging technology that has the speed and resolution to image fine structures such as drusen and the photoreceptor layers. With annotation and processing of three-dimensional SDOCT scans, focal AMD pathology such as drusen can be mapped and monitored over time. The AREDS2 Ancillary SDOCT Study (A2A SDOCT) added the use of novel higher resolution three-dimensional OCT retinal imaging at four AREDS2 study centers to examine 400 of the participants in the AREDS2 clinical trial.
The purpose of this ancillary AREDS2 study (study acronym: A2A_SDOCT) is to identify whether measurable AMD pathology (drusen, photoreceptor layer thickness, early findings of geographic atrophy (GA) or neovascularization) imaged by spectral domain optical coherence tomography (SDOCT) can predict progression of AMD and vision loss. The A2A_SDOCT study began as an ancillary AREDS2 study; however AREDS2 had stopped gathering participant data on October 31, 2012 and will be terminated soon. This extension study is needed to complete the AREDS2 dataset by collecting images at one or two additional time points, as the study started over a year behind the AREDS2 study. The data collection period for the extension will end April 30, 2014. Data analysis will conclude by October 31, 2014. All AREDS2 study procedure guidelines for data collection will be followed, as described below, even though this visit falls outside the AREDS2 study timeline.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Were enrolled in the AREDS2 protocol and successfully completed the final AREDS2 follow-up visit.
- Can understand and provide informed consent.
Key exclusion criteria (2 listed)
- 1. Are not able to return to NIH for examination for follow up visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vision loss outcome measure is mean change in visual acuity by Early Treatment Diabetic Retinopathy (ETDRS) score.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Background: PubMed 22840421AREDS2 Research Group; Chew EY, Clemons T, SanGiovanni JP, Danis R, Domalpally A, McBee W, Sperduto R, Ferris FL. The Age-Related Eye Disease Study 2 (AREDS2): study design and baseline characteristics (AREDS2 report number 1). Ophthalmology. 2012 Nov;119(11):2282-9. doi: 10.1016/j.ophtha.2012.05.027. Epub 2012 Jul 26.
- Background: PubMed 23644932Age-Related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. JAMA. 2013 May 15;309(19):2005-15. doi: 10.1001/jama.2013.4997.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai T Wong, M.D. principal investigator
National Eye Institute (NEI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AMD and Age- Related Macular Degeneration, run by National Eye Institute (NEI) at 2 sites in United States.
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 3 inclusion and 2 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 30 Aug 2017. 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. 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?
Vision loss outcome measure is mean change in visual acuity by Early Treatment Diabetic Retinopathy (ETDRS) score. (time frame: 1 year). 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 NCT01915238, 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 30 Aug 2017.