NCT03688243|UnknownFDA Device
Non Exudative AMD Imaged With SS-OCT
BIRC-01
Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography
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BIRC-01
Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography
Sponsor study identifier
observational
225
2 countries
5
Study Start
January 18, 2018
Actual (reported)Primary Completion
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 18, 2018
Actual (reported)September 25, 2018
Actual (reported)September 28, 2018
Actual (reported)March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in Choroidal Perfusion Deficits at 1 year compared to Baseline
Assessment of Choriocapillaris perfusion
1 year time point
Pre-existing sub-clinical Macular Neovascularization (MNV)
1 year and 2-year time points
Automated Drusen Volume measurements
1 year and 2-year time points
Automated GA measurements
1 year and 2-year time points
Structural OCT markers and Genetic Markers
1 year and 2-year time points
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
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
Subjects with GA enrolled in another trial
All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subjects with intermediate AMD, Geographic Atrophy and nascent Geographic Atrophy.
University of California Los Angeles Doheny Eye Institute
Los Angeles, California, 91105, United States
Bascom Palmer Eye Institue
Miami, Florida, 33136, United States
New England Eye Center/Tufts Medical Center
Boston, Massachusetts, 02111, United States
Vitreous Retina Macular Consultants of NY
New York, New York, 10022, United States
Melbourne University CERA
East Melbourne, Victoria, 3002, Australia
At baseline or follow up, an optional blood sample for future exploratory genetics analysis will be collected
Nadia Waheed, MD
Boston Image Reading Center/Tufts Medical Center
Philip Rosenfield, MD, PhD
Bascom Palmer Eye Institute
225 participants (actual enrollment reported by the registry).
First Submitted
September 25, 2018
First Posted
September 28, 2018
Study Start
January 18, 2018
Actual (reported)Study of NGM621 in Participants With Geographic Atrophy
Contact the study team to confirm eligibility.
Primary Completion
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 10, 2022
Record last verified: 2022-03
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Source: ClinicalTrials.gov.
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