Status:
UNKNOWN
Non Exudative AMD Imaged With SS-OCT- Extension
Lead Sponsor:
Boston Image Reading Center
Conditions:
Dry Macular Degeneration
Eligibility:
All Genders
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 pi...
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 pi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04469140
Start Date
January 18 2020
End Date
August 1 2025
Last Update
March 10 2022
Active Locations (5)
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1
University of California Los Angeles Doheny Eye Institute
Los Angeles, California, United States, 91105
2
Bascom Palmer Eye Institue
Miami, Florida, United States, 33136
3
New England Eye Center/Tufts Medical Center
Boston, Massachusetts, United States, 02111
4
Vitreous Retina Macular Consultants of NY
New York, New York, United States, 10022