Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
450 participants
OBSERVATIONAL
2020-01-18
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1 'IMPACT Cohort'
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
SS-OCT imaging
All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument
Cohort 2 'SWAGGER Cohort'
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
SS-OCT imaging
All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument
Cohort 3
Subjects with GA enrolled in another trial
SS-OCT imaging
All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument
Interventions
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SS-OCT imaging
All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Boston Image Reading Center
INDUSTRY
Responsible Party
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Principal Investigators
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Nadia Waheed, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Image Reading Center/Tufts Medical Center
Philip Rosenfield, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Bascom Palmer Eye Institute
Locations
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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
Vitreous Retina Macular Consultants of NY
New York, New York, United States
Melbourne University CERA
East Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Janett Mendez
Role: primary
Monica Arango
Role: primary
Nancy Gee, MPH
Role: primary
Renata Salgado
Role: primary
Emily Caruso
Role: primary
Other Identifiers
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BIRC-02 IMPACT SWAGGER
Identifier Type: -
Identifier Source: org_study_id
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