NCT04469140|UnknownFDA Device
Non Exudative AMD Imaged With SS-OCT- Extension
BIRC-02
Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography: The Extension Study
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BIRC-02
Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography: The Extension Study
Sponsor study identifier
observational
450
2 countries
5
Study Start
January 18, 2020
Actual (reported)Primary Completion
August 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2025
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.
August 2025
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, 2020
Actual (reported)June 23, 2020
Actual (reported)July 13, 2020
Actual (reported)August 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in the Percentage of Choroidal Perfusion Deficits at 1 year compared to Baseline
Compare the percentage of choroidal perfusion deficits as measured using automated algorithms
1-year and 2-year time points
Pre-existing and new sub-clinical Macular Neovascularization (MNV)
1-year and 2-year time points
Automated Drusen Volume measurements
1-year and 2-year time points
Automated Geography Atrophy measurements
1-year and 2-year time points
Choroidal Thickness (millimeters)
1-year and 2-year time points
Choroidal Vascularity Index (percentage)
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 and who have completed the BIRC-01 study
University of California Los Angeles Doheny Eye Institute
Los Angeles, California, 91105, United States
Bascom Palmer Eye Institue
Miami, Florida, 33136, United States
At baseline or follow up, an optional blood sample for future exploratory genetics analysis will be collected if not already collected during the BIRC-01 study
Nadia Waheed, MD
Boston Image Reading Center/Tufts Medical Center
Philip Rosenfield, MD, PhD
Bascom Palmer Eye Institute
First Submitted
June 23, 2020
First Posted
July 13, 2020
Study Start
January 18, 2020
Actual (reported)Primary Completion
August 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A Study Investigating the Efficacy and Safety of Intravitreal Injections of ANX007 in Patients With Geographic Atrophy
Contact the study team to confirm eligibility.
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
Study Completion
August 2025
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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