Non Exudative AMD Imaged With SS-OCT- Extension

Study Overview
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Brief Summary
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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.

Detailed Description
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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 an extension of a currently ongoing longitudinal observational study (BIRC-01) (NCT03688243).

Official Title
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Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography: The Extension Study

Conditions
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Dry Macular Degeneration

Intervention / Treatment
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* Device: SS-OCT imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrollment in and completion of the BIRC-01 study Clinic diagnosis of non-exudative iAMD in at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02 mm3 in the absence of GA or nGA as diagnosed with OCT en face imaging OR Clinical diagnosis of early or early/intermediate stage AMD in one eye in the absence of nGA or GA and exudative AMD in the other eye OR clinical diagnosis of 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 which has never been treated with anti-VEGF agents Willing and able to comply with clinic visits and study-related procedures Provide signed informed consent Exclusion Criteria: Subjects with exudative AMD in both eyes Eyes with evidence of non-proliferative and proliferative diabetic retinopathy. Presence of confounding ocular diagnosis such as myopia >6D, or other ocular conditions that may cause retinal pigment epithelium atrophy or exudative MNV Subjects currently or previously enrolled in other interventional clinical trials in which treatment was administered to the study eye. Previous vitrectomy or intravitreal injections in the study eye. Axial length measurement ≥ 26 mm. Subjects unable to give informed consent. Subjects who are unable to comply with imaging guidelines
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1 'IMPACT Cohort'<br>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 | Device: SS-OCT imaging<br>* All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument<br>* Other names: Optical Coherence Tomography Angiography;|
| Cohort 2 'SWAGGER Cohort'<br>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 | Device: SS-OCT imaging<br>* All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument<br>* Other names: Optical Coherence Tomography Angiography;|
| Cohort 3<br>Subjects with GA enrolled in another trial | Device: SS-OCT imaging<br>* All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument<br>* Other names: Optical Coherence Tomography Angiography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, Early AMD, Intermediate AMD, Geographic Atrophy, Nascent GA