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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.
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 an extension of a currently ongoing longitudinal observational study (BIRC-01) (NCT03688243).
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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 the Percentage of Choroidal Perfusion Deficits at 1 year compared to Baseline | Compare the percentage of choroidal perfusion deficits as measured using automated algorithms | 1-year and 2-year time points |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-existing and new sub-clinical Macular Neovascularization (MNV) | Identify the number of abnormal new vessels arising from the Choroid at Baseline, 1-year and 2-year time points | 1-year and 2-year time points |
| Automated Drusen Volume measurements |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with intermediate AMD, Geographic Atrophy and nascent Geographic Atrophy and who have completed the BIRC-01 study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jen Tourtellot | Contact | 1-855-535-BIRC (2472) | admin@bostonimagereadingcenter.com |
| 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 | Recruiting | 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 if not already collected during the BIRC-01 study
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Compare the automated measurements of drusen volume using the Zeiss algorithm with manual measurements by trained readers
| 1-year and 2-year time points |
| Automated Geography Atrophy measurements | Compare the automated measurements of Geography Atrophy area using the Zeiss algorithm with manual measurements by trained readers | 1-year and 2-year time points |
| Choroidal Thickness (millimeters) | Correlate Choroidal Thickness measurements (millimeters) with Age related Macular Degeneration (AMD) progression/Geographic Atrophy growth rates | 1-year and 2-year time points |
| Choroidal Vascularity Index (percentage) | Correlate Choroidal Vascularity Index (percentage) with Age related Macular Degeneration (AMD) progression/Geographic Atrophy growth rates | 1-year and 2-year time points |
| Bascom Palmer Eye Institue | Recruiting | Miami | Florida | 33136 | United States |
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| New England Eye Center/Tufts Medical Center | Recruiting | Boston | Massachusetts | 02111 | United States |
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| Vitreous Retina Macular Consultants of NY | Recruiting | New York | New York | 10022 | United States |
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| Melbourne University CERA | Recruiting | East Melbourne | Victoria | 3002 | Australia |
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