NCT04907409|UnknownDMC
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Sponsor study identifier
observational
120
1 country
7
Study Start
June 17, 2021
Actual (reported)Primary Completion
July 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a single arm study of home monitoring with the NVHO for 5 weeks with office visits at enrollment, Week 1 and Week 5 (Exit Visit) and, when applicable, Interim Visit(s) triggered by ongoing review by the Reading Center. The study will enroll subjects diagnosed with NV-AMD in at least one eye with attention to the proportion of eyes with IRF and/or SRF. The enrolled eligible subjects will be instructed to self-image the study eye(s) once daily for 5 weeks using a NVHO device at home with scheduled in-office examinations at Week 1, Week 5 and Interim Visits, when applicable, with additional in-office Cirrus volume scans acquired at these office visits. The self-imaging data on the NVHO will be automatically uploaded to the Notal Health Cloud and from there the reconstructed volume scans will sent to the study database.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 25, 2021
Actual (reported)May 28, 2021
Actual (reported)June 17, 2021
Actual (reported)July 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Positive percent agreement
Positive percent agreement (PPA) of fluid status when comparing the fluid status in the central 3mm X 3mm of the NVHO volume scan graded by an independent reading center to the fluid status in the central 3mm X 3mm of Cirrus volume scan graded by an independent reading center.
1 month following reading center grading completion
Negative percent agreement
Negative percent agreement (NPA) of fluid status when comparing the fluid status in the central 3mm X 3mm of the NVHO volume scan graded by an independent reading center to the fluid status in the central 3mm X 3mm Cirrus volume scan graded by an independent reading center.
1 month following reading center grading completion
Percentage of subjects who successfully completed the setup of the NVHO device
Percentage of subjects who successfully completed the setup of the NVHO, indicated by the initiation of the tutorial.
5-10 minutes
Percentage of subjects who Successful completed NVHO self-imaging
Percentage of subjects who Successful completed NVHO self-imaging, namely a volume macular scan has been captured.
2-3 minutes
Percentage of all sessions that were transmission successfully
10-15 minutes
Percentage of sessions containing self-imaging that were transmitted successfully
10-15 minutes
Adult subjects diagnosed with neovascular age-related macular degeneration (NV-AMD) in at least one eye at the time of enrollment.
Georgia Retina
Marietta, Georgia, 30060, United States
Retina Associates of Kentucky
Lexington, Kentucky, 40509, United States
Gidi Benyamini, MD
Druyanov 5, Tel Aviv Israel
First Submitted
May 25, 2021
First Posted
May 28, 2021
Study Start
June 17, 2021
Actual (reported)Primary Completion
July 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study
Contact the study team to confirm eligibility.
Elman Retina Group, P.A.
Glen Burnie, Maryland, 21061, United States
Ophthalmic Cons. of Boston
Boston, Massachusetts, 02114, United States
Pepose Vision Institute/Midwest Vision Research Foundation
Chesterfield, Missouri, 63017, United States
Wagner Macula & Retina Center
Norfolk, Virginia, 23502, United States
Virginia Eye Institute
Richmond, Virginia, 23230, United States
Study Completion
August 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 9, 2022
Record last verified: 2022-01
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Source: ClinicalTrials.gov.
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