Dry Macular Degeneration
Conditions
Keywords
AMD, Early AMD, Intermediate AMD, Geographic Atrophy, Nascent GA
Brief summary
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
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).
Interventions
DEVICESS-OCT imaging
All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument
Sponsors
Boston Image Reading Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Percentage of Choroidal Perfusion Deficits at 1 year compared to Baseline | 1-year and 2-year time points | Compare the percentage of choroidal perfusion deficits as measured using automated algorithms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Automated Drusen Volume measurements | 1-year and 2-year time points | Compare the automated measurements of drusen volume using the Zeiss algorithm with manual measurements by trained readers |
| Pre-existing and new sub-clinical Macular Neovascularization (MNV) | 1-year and 2-year time points | Identify the number of abnormal new vessels arising from the Choroid at Baseline, 1-year and 2-year time points |
| Automated Geography Atrophy measurements | 1-year and 2-year time points | Compare the automated measurements of Geography Atrophy area using the Zeiss algorithm with manual measurements by trained readers |
| Choroidal Thickness (millimeters) | 1-year and 2-year time points | Correlate Choroidal Thickness measurements (millimeters) with Age related Macular Degeneration (AMD) progression/Geographic Atrophy growth rates |
| Choroidal Vascularity Index (percentage) | 1-year and 2-year time points | Correlate Choroidal Vascularity Index (percentage) with Age related Macular Degeneration (AMD) progression/Geographic Atrophy growth rates |
Countries
Australia, United States
Contacts
Primary ContactJen Tourtellot
Outcome results
None listed