Non Exudative AMD Imaged With SS-OCT
- Conditions
- Dry Macular Degeneration
- Interventions
- Device: SS-OCT imaging
- Registration Number
- NCT03688243
- Lead Sponsor
- Boston Image Reading Center
- 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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 225
- Aged 50 and over
- 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
A subject who meets any of the following criteria will be excluded from the study:
- Below the age of 50
- 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 unable to give informed consent.
- Subjects who are unable to comply with imaging guidelines
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 'IMPACT Cohort' SS-OCT imaging 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 Cohort 2 'SWAGGER Cohort' SS-OCT imaging 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 Cohort 3 SS-OCT imaging Subjects with GA enrolled in another trial
- Primary Outcome Measures
Name Time Method Change in Choroidal Perfusion Deficits at 1 year compared to Baseline 1 year time point Assessment of Choriocapillaris perfusion
- Secondary Outcome Measures
Name Time Method Pre-existing sub-clinical Macular Neovascularization (MNV) 1 year and 2-year time points Presence of abnormal new vessels arising from the Choroid
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
Structural OCT markers and Genetic Markers 1 year and 2-year time points Correlate structural markers on SS-OCT/OCTA with genetic markers of disease
Automated GA measurements 1 year and 2-year time points Compare the automated measurements of GA area using the Zeiss algorithm with manual measurements by trained readers
Trial Locations
- Locations (5)
Vitreous Retina Macular Consultants of NY
🇺🇸New York, New York, United States
Melbourne University CERA
🇦🇺East Melbourne, Victoria, Australia
University of California Los Angeles Doheny Eye Institute
🇺🇸Los Angeles, California, United States
Bascom Palmer Eye Institue
🇺🇸Miami, Florida, United States
New England Eye Center/Tufts Medical Center
🇺🇸Boston, Massachusetts, United States