Natural History of Geographic Atrophy Associated With Age-Related Macular Degeneration (NCT02941263) | Clinical Trial Compass
CompletedNot Applicable
Natural History of Geographic Atrophy Associated With Age-Related Macular Degeneration
United States20 participantsStarted 2017-03-08
Plain-language 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. 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....
Who can participate
Age range
55 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Participant is actively receiving study therapy in another investigational study.
. Participant is unable to comply with study procedures or follow-up visits.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a natural history study that was tracking how geographic atrophy grows over time rather than testing a treatment, what can my doctor tell me about what was actually learned from this study, and how might those findings affect my own care plan?
2This trial measured the rate at which the area of geographic atrophy changed using fundus autofluorescence imaging — is that type of imaging something my doctor already uses to monitor my condition, and what would my own results tell us?
3Because this study has already been completed, are there published results my doctor has seen that help predict how quickly geographic atrophy tends to progress in patients like me?
4Since this was an observational study with no experimental treatment involved, does my doctor think I should now be looking at interventional trials that are actively testing therapies for geographic atrophy, given where my condition currently stands?
5Are there factors this trial was tracking — such as lesion size, growth rate, or imaging patterns — that my doctor can measure in me right now to help us understand my prognosis and plan next steps?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: Calculated 45 months as compared to baseline
. 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 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.
. 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):