By: Notal Vision
Manassas, VA, June 17, 2020 (GLOBE NEWSWIRE) — Notal Vision is proud to announce the enrollment of patients in the first longitudinal home-based study with its investigational home optical coherence tomography (OCT) remote monitoring device. The study will explore the daily dynamics of retinal fluid in patients receiving anti-VEGF treatment for wet age-related macular degeneration (AMD). The Home OCT System pipeline technology is designed to provide home-based, patient-initiated retinal OCT scans to support the management of patients with wet AMD, complementing existing standard of care treatments as well as emerging longer-acting drugs and drug delivery systems.
“The study is an important milestone for our Home OCT pipeline program,” said Kester Nahen, Ph.D., CEO of Notal Vision. “We look forward to expanding the remote patient monitoring services our Notal Vision Diagnostic Clinic provides to referring physicians. Home OCT is designed to be part of the next step in an AMD patient’s journey after ForeseeHome, which monitors patients with intermediate dry AMD at risk of converting to wet.”
The study will include up to 15 wet AMD patients recruited by two medical centers in Tel Aviv, Israel – Tel Aviv Medical Center and Assuta HaShalom. Patients participating in the study will perform a daily scan of their eye(s) for one month with the easy-to-use home-based device, which captures dense OCT volume scans of the macula. OCT scans will be automatically uploaded to the Notal Health Cloud, a secure cloud-based system used to process, store, and manage data. OCT images will then be reviewed remotely by study investigators through the system’s Web Viewer, an interactive interface that displays patients’ testing information over time.
“Home OCT will provide treating physicians with inter-visit disease knowledge and help us reduce the treatment and monitoring burden on patients and their caregivers,” said Anat Loewenstein, MD, the study’s principal investigator and the Director of the Department of Ophthalmology at Tel Aviv Medical Center. “Daily monitoring of disease activity will aid retina specialists in achieving the desired visual acuity outcomes for their patients using existing and emerging treatment modalities.”
Notal Vision’s home-based OCT pipeline technology received FDA Breakthrough Device designation at the end of 2018 and is in the process of obtaining FDA clearance. In January 2020 the American Medical Association established three categories III Current Procedural Terminology (CPT®) codes for reporting patient-initiated remote retinal OCT scans, facilitated by Notal Vision’s home-based OCT. Results from a clinic-based trial using the final form factor of the Home OCT presented earlier this year showed that the areas of fluid seen on the system’s intra- and subretinal fluid thickness maps correlated with the locations of abnormal vessels seen on OCT angiography, as well as leakage areas on fluorescein angiography, demonstrating the technology’s ability to track disease status. In the same study, 90% of wet AMD patients self-imaged successfully on the Home OCT device demonstrating the ease of use in an elderly patient population. The image quality was shown to be sufficient for a human grader to identify fluid in one of three consecutive tests with a sensitivity and specificity of 97% and 95%, respectively.
Notal Vision will present a company update, including information about the home-based study, during the virtual Ophthalmology Innovation Summit (OIS) Israel 2020 investor conference on June 18 from 1-3 pm EDT https://ois.net/ois-israel-2020/.
Read more: https://www.globenewswire.com/news-release/2020/06/17/2049409/0/en/Home-OCT-longitudinal-home-based-study-with-patient-self-operated-device-has-begun.html
Source: Notal Vision