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The investigators wish to better understand the role of the choriocapillaris (CC) in the formation and progression of non-exudative in age related macular degeneration (armd) by imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by studying their inter-dependence to determine if the loss of the CC could prove useful as an anatomic clinical trial endpoint in future drug trials.
This is a longitudinal observational study where the investigators will look at 450 subjects, 200 with intermediate AMD in at least one eye, or with AMD in one eye, either early or intermediate, and with late AMD (exudative) in the other eye, and 250 subjects with nGA or GA in at least one eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 'IMPACT Cohort' | Subjects with intermediate AMD in both eyes, and at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02mm3 in the absence of GA or nGA as diagnosed with OCT en face imaging OR subjects with AMD (early or intermediate) diagnosed in one eye and exudative AMD diagnosed in the fellow eye will undergo SS-OCT imaging every 3 months for 2 years |
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| Cohort 2 'SWAGGER Cohort' | Subjects with GA or nGA secondary to AMD that is at least the size of a large druse (125 microns in diameter; 0.05 mm2) and no greater than 7 disc areas (17 mm2) in at least one eye will undergo SS-OCT imaging every 3 months for 2 years |
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| Cohort 3 | Subjects with GA enrolled in another trial |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SS-OCT imaging | Device | All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Choroidal Perfusion Deficits at 1 year compared to Baseline | Assessment of Choriocapillaris perfusion | 1 year time point |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-existing sub-clinical Macular Neovascularization (MNV) | Presence of abnormal new vessels arising from the Choroid | 1 year and 2-year time points |
| Automated Drusen Volume measurements | Compare the automated measurements of drusen volume using the Zeiss algorithm with manual measurements by trained readers |
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Inclusion Criteria:
Exclusion Criteria:
A subject who meets any of the following criteria will be excluded from the study:
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Subjects with intermediate AMD, Geographic Atrophy and nascent Geographic Atrophy.
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| Name | Affiliation | Role |
|---|---|---|
| Nadia Waheed, MD | Boston Image Reading Center/Tufts Medical Center | Principal Investigator |
| Philip Rosenfield, MD, PhD | Bascom Palmer Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles Doheny Eye Institute | Los Angeles | California | 91105 | United States | ||
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| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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At baseline or follow up, an optional blood sample for future exploratory genetics analysis will be collected
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| 1 year and 2-year time points |
| Automated GA measurements | Compare the automated measurements of GA area using the Zeiss algorithm with manual measurements by trained readers | 1 year and 2-year time points |
| Structural OCT markers and Genetic Markers | Correlate structural markers on SS-OCT/OCTA with genetic markers of disease | 1 year and 2-year time points |
| Bascom Palmer Eye Institue |
| Miami |
| Florida |
| 33136 |
| United States |
| New England Eye Center/Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Vitreous Retina Macular Consultants of NY | New York | New York | 10022 | United States |
| Melbourne University CERA | East Melbourne | Victoria | 3002 | Australia |