When the Food and Drug Administration established breakthrough device designation in 2016, the idea was to offer manufacturers an expedited review pathway for devices that “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.”
In December 2018, the FDA bestowed that designation on the Notal Vision Home OCT System, a cloud-based optical coherence tomography platform that patients diagnosed with wet age-related macular degeneration can use in their home. The artificial-intelligence-based device is designed for remote monitoring of retinal fluid changes in the central 10 degrees. Notal Vision says it hopes to bring the home-based OCT to market next year.
Potential advantages of in-home OCT
Among the retina specialists evaluating the home-based OCT in the clinic is Judy E. Kim, MD, a professor at the Medical College of Wisconsin in Milwaukee. (Dr. Kim is a paid adviser to Notal Vision on the product.)
“Much of our diagnosis and treatment of diseases such as age-related macular degeneration, diabetic macular edema, central serous chorioretinopathy, retinal vein occlusion and many other conditions are guided by the OCT findings,” Dr. Kim says. “Currently these images can be obtained only in doctors’ offices, requiring the patients to come in for a visit.”
Moving that function from the doctor’s office and into a more convenient place for patients offers a number of benefits, Dr. Kim notes. “Can you imagine what it would be like to have these OCTs at patients’ homes?” she asks. “The advantages are obvious.”
Finding the optimal interval
One of the challenges of treating patients with retinal diseases is learning the optimal treatment interval for each individual patient. “As a result, we have various dosing schedules, such as monthly, as needed, or treat-and-extend,” Dr. Kim notes. “Instead of overtreating some patients with monthly dosing or risking recurrences with as-needed dosing or guessing how far to extend the interval between injections, we will now know exactly when the fluid recurs and patients can come in then.”
In-home OCT monitoring can potentially address the second treatment challenge retina specialists have with these patients: minimizing the treatment burden while minimizing vision loss from undiagnosed fluid recurrence.
“Home OCT will allow us to gain better knowledge of a patient’s response to one drug over another in a more dynamic and timely manner,” Dr. Kim says. “We will be able to treat patients in a more timely and individualized manner with home OCT.”
Individualizing treatment schedules
She notes both the HARBOR1 and CATT2 trials reported wide disparities in the frequency of injections among patients; some needed only three injections over 23 months while others needed monthly treatments. As every retina specialist knows, determining what treatment interval the patient would benefit most from is a trial-and-error process that requires multiple office visits.
“Home-based OCT may help in reducing the treatment burden and in adopting a more individualized treatment approach,” Dr. Kim says. “This may result in increased compliance with needed injections.”
She also points out that as more drugs are being investigated for longer durability, determining the optimal dosing interval will be critical. “We should also remember that every injection carries a small but known risks of endophthalmitis, intraocular pressure elevation, vitreous hemorrhage and retinal detachment. Therefore, it would be ideal to be treated only when treatment is needed,” says Dr. Kim.
“To achieve this end, the quality of OCT images and the accuracy of AI-based readings of the images will be important,” she says of the homebased OCT system.
Ease of use, image quality
Three sites in the United States are evaluating the home-based OCT. “What I hear from them is that it’s easy to use by the patients, even in their 80s and 90s,” she says. The evaluation sites are also validating image quality compared to in-office OCT and will present those findings at upcoming retina meetings.
Dr. Kim also notes that the notification alert system—when in-home monitoring detects significant retinal fluid changes and how the retina specialist gets that information—is still a work in progress.
Given that Notal already has a platform for its cloud-based ForeseeHome that provides monitoring of changes in metamorphopsia in patients at risk for converting to neovascular AMD, Dr. Kim believes the home system can utilize a similar work flow. “Home OCT is an exciting innovation that has the potential to greatly impact and benefit our patients and their physicians,” she says.
1. Busbee BG, Ho AC, Brown DM, et al. HARBOR Study Group. Twelve-month efficacy and safety of 0.5 mg or 2.0 mg ranibizumab in patients with subfoveal neovascular age-related macular degeneration. Ophthalmology. 2013;120:1046-1056.
2. Martin DF, Maguire MG, Fine SL, et al. Comparison of Age-related Macular Degeneration Treatments Trial (CATT) Research Group. Ranizibumab and bevacizumab for treatment of neovascular age- related macular degeneration: two-year results. Ophthalmology. 2012;119:1388-1398.