Age-Related Macular DegenerationNCT02941263
Natural History of Geographic Atrophy Associated With Age-Related Macular Degeneration
An observational study of Age-Related Macular Degeneration, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
Background: Age-related macular degeneration (AMD) affects the macula in the eye. This is the central part of the retina. It is needed for sharp, clear vision and activities like reading and driving. AMD is the leading cause of vision loss in Americans 60 years of age and older. Read more about this study
- Who is it for?
- Ages 55 to 120 years
- Conditions the study is for
- Age-Related Macular Degeneration
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2017to 22 May 2024
- 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 55 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Twenty-five (25) participants, age 55 years and older, with unilateral or bilateral GA associated with atrophic AMD will be accrued.
Who may be able to join
- To be eligible, the following inclusion criteria must be met, where applicable.
- Participant must be 55 years of age or older.
- Participant must understand and sign the protocol s informed consent document.
- Participant must have evidence of early or intermediate AMD as defined by characteristic presence of drusen and/or pigmentary changes.
- Participant is enrolled in one of the following screening protocols: 08-EI-0102, 08-EI-0169 (closed), 08-EI-0043, 12-EI-0042, 11-EI-0147, or 16-EI-0134.
Who cannot join
- A participant is not eligible if any of the following exclusion criteria are present.
- Participant is actively receiving study therapy in another investigational study.
- Participant is unable to comply with study procedures or follow-up visits.
- Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve (e.g., ethambutol, chloroquine, or hydroxychloroquine).
- STUDY EYE ELIGIBILITY CRITERIA:
- The participant must have at least one eye meeting all inclusion criteria and none of the exclusion criteria listed below.
Show all 22Show fewer
- STUDY EYE INCLUSION CRITERIA:
- The study eye(s) must have GA compatible with dry AMD. GA is defined as one or more well-defined and often circular patches of partial or complete depigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round patch of RPE partial depigmentation may be classified as early GA. The GA in the study eye must be able to be photographed in their entirety and it must not be contiguous with any areas of peripapillary atrophy, which can complicate area measurements.
- The study eye(s) must have clarity of ocular media and degree of pupil dilation sufficient to permit adequate fundus photographs.
- STUDY EYE EXCLUSION CRITERIA:
- Current evidence of neovascularization as determined by the treating physician or a history of treatments for neovascularization.
- Evidence of retinal atrophy due to causes other than atrophic AMD.
- Current evidence or history of ocular disorders in the study eye that might confound study outcome measures, including (but not limited to):
- non-proliferative diabetic retinopathy involving 10 or more hemorrhages or microaneurysms, or active proliferative diabetic retinopathy
- Branch or central retinal vein or artery occlusion
- Macular hole
- Pathologic myopia
- Uveitis
- Pseudovitelliform maculopathy
- History of vitreoretinal surgery.
- Need for ocular surgery during the course of the study.
- Recent history of lens removal (< 3 months prior to enrollment) or Yttrium Aluminum Garnet (YAG) laser capsulotomy (< 1 month prior to enrollment).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: The Natural History of Geographic Atrophy Associated With Age-Related Macular Degeneration
Background:
Age-related macular degeneration (AMD) affects the macula in the eye. This is the central part of the retina. It is needed for sharp, clear vision and activities like reading and driving. AMD is the leading cause of vision loss in Americans 60 years of age and older. An advanced form of AMD is called geographic atrophy or GA. It happens when light-sensitive cells in the macula die so much that central vision decreases.
Read more
Objective:
To learn more about geographic atrophy associated with age-related macular degeneration.
Eligibility:
Adults at least 55 years old with a certain kind of GA. They must be enrolled in study 08-EI-0102, 08-EI-0169, 08-EI-0043, 12-EI-0042, or 11-EI-0147 but no other studies.
Design:
Participants will be screened with medical history, physical exam, and an eye exam.
Participants will have study visits every 3 months for 15 months, then every 6 months. They will be in the study almost 4 years.
Visits will last about 8 hours. At each visit, participants may have:
- Medical and eye history. Participants will answer questions about their general health and eye health. They may answer written questions about how their eye problems affect their life.
- Eye exam and photographs. Eye pressure will be measured and eye movements will be checked. Pupils will be dilated with drops. The thickness of the retina will be measured and photos of the eye may be taken.
Read the detailed description
Objective: Age-related macular degeneration (AMD), the leading cause of blindness in people over age 65 in the United States, is a heterogeneous clinical entity in which retinal degeneration occurs predominantly in the macula in the context of aging and leads to impairment of central visual acuity (VA). AMD occurs in two general forms, one of which involves choroidal neovascularization (CNV) with subsequent formation of a disciform scar. This is often referred to as the neovascular or wet form. A second form, the subject of this study, is termed dry atrophic macular degeneration or otherwise geographic atrophy (GA) and involves a slow progressive atrophy of retinal pigment epithelial (RPE) cells and photoreceptors in the macula, also resulting in central vision loss. GA is estimated to affect up to one million people in the U.S. and there is no current treatment that can prevent its onset. While the etiology of GA is not completely understood, inflammatory processes involving the activation of resident immune cells of the retina called microglia are likely to contribute. The objective of this study is to study the progression of GA so as to be able to characterize in quantitative terms the natural progression of GA in patients, whether or not they are receiving any directed treatment.
Study Population: Twenty-five (25) participants with unilateral or bilateral GA associated with AMD will be enrolled.
Design: This prospective, natural history study will follow participants with GA associated with AMD.
Outcome Measures:
The primary outcome is the rate of change in area of GA based on grading by an external Reading Center of fundus autofluorescence (FAF) images in the assigned study eye. The primary outcome will be calculated for 45 months as compared to baseline.
Secondary outcomes will include changes in best-corrected visual acuity (BCVA), rate of change in area of GA based on fundus photography and development of exudative AMD ascertained using optical coherence tomography (OCT) and changes in macular sensitivity.
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Eye Disease, Natural History
- Medical subject headings
- Macular Degeneration, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Affected Participants | Participants with unilateral or bilateral GA associated with atrophic AMD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the difference in the mean rate of change in area of GA in the study eye based on digital grading of FAF images by an external Reading Center.
Difference in the mean rate of change in area of GA in the study eye based on digital grading of FAF images by an external Reading Center.
Measured: Calculated 45 months as compared to baseline
Secondary outcomes (1)
Differences in study eyes for the following: mean rate of change in area of GA based on digital grading of color fundus images, mean changes in BCVA, mean changes in central retinal thickness on OCT, and the proportion of study eyes developing w...
Differences in the study eyes for the following outcome measures: mean rate of change in area of GA based on digital grading of color fundus images by an external reading center, mean changes in BCVA, mean changes in central retina thickness on OCT and the proportion of study eyes developing wet AMD determined by OCT.
Measured: 45 months as compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start8 Mar 2017
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tiarnan DL Keenan, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941263
- Sponsor's protocol ID
- 170008
- Other IDs
- 17-EI-0008
- Status last verified
- 2 Feb 2026
- First submitted
- 20 Oct 2016
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History of Geographic Atrophy Associated With Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02941263
- Acronym / sponsor ID
- 170008
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Eye Disease, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 21 Oct 2016 (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:
Age-related macular degeneration (AMD) affects the macula in the eye. This is the central part of the retina. It is needed for sharp, clear vision and activities like reading and driving. AMD is the leading cause of vision loss in Americans 60 years of age and older. An advanced form of AMD is called geographic atrophy or GA. It happens when light-sensitive cells in the macula die so much that central vision decreases.
Objective:
To learn more about geographic atrophy associated with age-related macular degeneration.
Eligibility:
Adults at least 55 years old with a certain kind of GA. They must be enrolled in study 08-EI-0102, 08-EI-0169, 08-EI-0043, 12-EI-0042, or 11-EI-0147 but no other studies.
Design:
Participants will be screened with medical history, physical exam, and an eye exam.
Participants will have study visits every 3 months for 15 months, then every 6 months. They will be in the study almost 4 years.
Visits will last about 8 hours. At each visit, participants may have:
- Medical and eye history. Participants will answer questions about their general health and eye health. They may answer written questions about how their eye problems affect their life.
- Eye exam and photographs. Eye pressure will be measured and eye movements will be checked. Pupils will be dilated with drops. The thickness of the retina will be measured and photos of the eye may be taken.
Detailed description
Objective: Age-related macular degeneration (AMD), the leading cause of blindness in people over age 65 in the United States, is a heterogeneous clinical entity in which retinal degeneration occurs predominantly in the macula in the context of aging and leads to impairment of central visual acuity (VA). AMD occurs in two general forms, one of which involves choroidal neovascularization (CNV) with subsequent formation of a disciform scar. This is often referred to as the neovascular or wet form. A second form, the subject of this study, is termed dry atrophic macular degeneration or otherwise geographic atrophy (GA) and involves a slow progressive atrophy of retinal pigment epithelial (RPE) cells and photoreceptors in the macula, also resulting in central vision loss. GA is estimated to affect up to one million people in the U.S. and there is no current treatment that can prevent its onset. While the etiology of GA is not completely understood, inflammatory processes involving the activation of resident immune cells of the retina called microglia are likely to contribute. The objective of this study is to study the progression of GA so as to be able to characterize in quantitative terms the natural progression of GA in patients, whether or not they are receiving any directed treatment.
Study Population: Twenty-five (25) participants with unilateral or bilateral GA associated with AMD will be enrolled.
Design: This prospective, natural history study will follow participants with GA associated with AMD.
Outcome Measures:
The primary outcome is the rate of change in area of GA based on grading by an external Reading Center of fundus autofluorescence (FAF) images in the assigned study eye. The primary outcome will be calculated for 45 months as compared to baseline.
Secondary outcomes will include changes in best-corrected visual acuity (BCVA), rate of change in area of GA based on fundus photography and development of exudative AMD ascertained using optical coherence tomography (OCT) and changes in macular sensitivity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Affected Participants | – | –Participants with unilateral or bilateral GA associated with atrophic AMD. |
Who may qualify
- Ages
- 55 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty-five (25) participants, age 55 years and older, with unilateral or bilateral GA associated with atrophic AMD will be accrued.
Key inclusion criteria (5 listed)
- To be eligible, the following inclusion criteria must be met, where applicable.
- Participant must be 55 years of age or older.
- Participant must understand and sign the protocol s informed consent document.
- Participant must have evidence of early or intermediate AMD as defined by characteristic presence of drusen and/or pigmentary changes.
- Participant is enrolled in one of the following screening protocols: 08-EI-0102, 08-EI-0169 (closed), 08-EI-0043, 12-EI-0042, 11-EI-0147, or 16-EI-0134.
Key exclusion criteria (22 listed)
- A participant is not eligible if any of the following exclusion criteria are present.
- Participant is actively receiving study therapy in another investigational study.
- Participant is unable to comply with study procedures or follow-up visits.
- Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve (e.g., ethambutol, chloroquine, or hydroxychloroquine).
- The participant must have at least one eye meeting all inclusion criteria and none of the exclusion criteria listed below.
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
The primary outcome is the difference in the mean rate of change in area of GA in the study eye based on digital grading of FAF images by an external Reading Center.
Time frame: Calculated 45 months as compared to baseline
Difference in the mean rate of change in area of GA in the study eye based on digital grading of FAF images by an external Reading Center.
1 secondary outcome
Differences in study eyes for the following: mean rate of change in area of GA based on digital grading of color fundus images, mean changes in BCVA, mean changes in central retinal thickness on OCT, and the proportion of study eyes developing w...
Time frame: 45 months as compared to baseline
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 28 Aug 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Tiarnan DL Keenan, M.D. principal investigator
National Eye Institute (NEI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration, run by National Eye Institute (NEI) at 1 site 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 5 inclusion and 22 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 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The primary outcome is the difference in the mean rate of change in area of GA in the study eye based on digital grading of FAF images by an external Reading Center. (time frame: Calculated 45 months as compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2026.