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 range55 Years – 120 Years
SexALL
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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.
✕. 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.
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