Home OCT Fluid Visualization Agreement Study
1 other identifier
observational
120
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2021
CompletedFirst Posted
Study publicly available on registry
May 28, 2021
CompletedStudy Start
First participant enrolled
June 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedMarch 9, 2022
January 1, 2022
1.1 years
May 25, 2021
March 8, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (2)
Percentage of all sessions that were transmission successfully
10-15 minutes
Percentage of sessions containing self-imaging that were transmitted successfully
10-15 minutes
Eligibility Criteria
Adult subjects diagnosed with neovascular age-related macular degeneration (NV-AMD) in at least one eye at the time of enrollment.
You may qualify if:
- Subjects must have the ability to speak, read and understand English.
- Ability to understand and agree to contents of informed consent either in writing or verbally.
- Age 55 or older at the Enrollment Visit.
- Adults diagnosed with NV-AMD in at least one eye based on the subject's medical record. Fellow eyes diagnosed with dry AMD may be included as secondary eyes to a primary eye diagnosed with NV-AMD.
- Note: eyes whit other pathologies including pseudocysts, outer retinal tabulations, pigments epithelial, detachments, hemorrhage, sub retinal hyper reflective material (SHRM), geographic atrophy and sub RPE, hypo reflective areas can be enrolled.
- Best corrected Visual Acuity of 20/320 or better in eyes that will perform self-imaging.
- Available and willing to set up a device and conduct self-imaging at their home.
You may not qualify if:
- Anti-VEGF treatment for NV-AMD in the study eye(s) at the screening visit.
- Any other retinal disease requiring steroidal or anti-VEGF injections.
- Prior experience with the NVHO device.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Georgia Retina
Marietta, Georgia, 30060, United States
Retina Associates of Kentucky
Lexington, Kentucky, 40509, United States
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 Officials
- STUDY DIRECTOR
Gidi Benyamini, MD
Druyanov 5, Tel Aviv Israel
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2021
First Posted
May 28, 2021
Study Start
June 17, 2021
Primary Completion
July 30, 2022
Study Completion
August 30, 2022
Last Updated
March 9, 2022
Record last verified: 2022-01