Non Exudative AMD Imaged With SS-OCT- Extension
- Conditions
- Dry Macular Degeneration
- Interventions
- Device: SS-OCT imaging
- Registration Number
- NCT04469140
- 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
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 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 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 3 SS-OCT imaging Subjects with GA enrolled in another trial
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
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
Trial Locations
- Locations (5)
Bascom Palmer Eye Institue
🇺🇸Miami, Florida, United States
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
New England Eye Center/Tufts Medical Center
🇺🇸Boston, Massachusetts, United States