Asclepix Therapeutics partners with Notal Vision on Home OCT remote monitoring in DME and AMD clinical trials
The technology could set new standards for data enrichment and patient-centric conduct of clinical trials
Notal Vision, Inc. announced today that the company will provide AsclepiX Therapeutics with Home OCT monitoring services through its Notal Vision Diagnostic Clinic to support AsclepiX’s AXT107 phase 1 clinical trial program. The exploratory application of the investigational home monitoring platform will add new valueable data points between the regulary scheduled study office visits.
Study subjects with diabetic macular edema (DME) and wet age-related macular degeneration (AMD), who participate in the CONGO and SHASTA study sponsored by AsclepiX Therapeutics, will perform sequential daily self-imaging of their eyes with the user-friendly, self-operated Notal Home OCT device in their homes. The Notal Vision Diagnostic Clinic, future provider of the Home OCT program, will monitor patient compliance for daily self-imaging and provide remote support as needed. Data from the Home OCT device will be automatically transmitted via a built-in cellular modem to the secure Notal Health Cloud, where the AI-based Notal OCT Analyzer (NOATM) will identify and quantify intra- and subretinal fluid from each daily OCT volume scan. Home OCT images and temporal fluid volume trajectories will be shared with AsclepiX and can be made available to the investigators through the Notal Physician Portal.
“Remote OCT monitoring of patients with exudative retinal diseases in a regulatory clinical trial allows AsclepiX Therapeutics to capture critical data points while potentially reducing the burden of frequent office visits” said Dr. Arshad M. Khanani, MD, MA, one of the study’s investigators and Director of Clinical Research at Sierra Eye Associates in Reno, NV. “The clinical value and potential benefit of such an approach is even more crucial now in light of the COVID-19 pandemic.”
“Home OCT monitoring opens new opportunities to enrich clinical trial datasets with inter-visit disease and treatment response knowledge,” said Kester Nahen, PhD, CEO of Notal Vision, Inc. “We are excited to partner with AsclepiX Therapeutics and contribute our remote diagnostic services to their early phase clinical trial program”.
Notal Vision’s Home OCT pipeline technology is designed to provide patient-initiated retinal OCT scans to support the management of patients with exudative retinal diseases, complementing existing standard of care treatments as well as emerging longer acting drugs. 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 category III Current Procedural Terminology (CPT®) codes for reporting patient-initiated remote retinal OCT scans, facilitated by Notal Vision’s home-based OCT. The physician review, interpretation and documentation of AI-based analyses will be billable every 30 days.
About Notal Vision
Notal Vision is a diagnostic services company that operates the Notal Vision Diagnostic Clinic, a medical provider with a proven platform for engaging patients and AI-enabled analyses of high-volume personalized health data that extends disease management from the clinic to the home to improve vision outcomes, reduce treatment burden, and improve health economics. www.notalvision.com