Home OCT Fluid Visualization Agreement Study

Status unconfirmed

Conditions studied: Neovascular Age-related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT04907409

Run by

Notal Vision Inc.

People needed

120

Starts

2021-06-17

Expected to finish

2022-08-30

Last updated by the study team

2022-03-09

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Georgia Retina — Marietta, Georgia, United States (enrolling)
• Retina Associates of Kentucky — Lexington, Kentucky, United States (enrolling)
• Elman Retina Group, P.A. — Glen Burnie, Maryland, United States (enrolling)
• Ophthalmic Cons. of Boston — Boston, Massachusetts, United States (enrolling)
• Pepose Vision Institute/Midwest Vision Research Foundation — Chesterfield, Missouri, United States (enrolling)
• Wagner Macula & Retina Center — Norfolk, Virginia, United States (enrolling)
• Virginia Eye Institute — Richmond, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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