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The Real-World Study

March 2024

In last month’s newsletter, we looked at the original clinical trial, the HOME Study, which showed that vision at the time of conversion to wet age-related macular degeneration (AMD) was better with ForeseeHome and standard care monitoring than standard care monitoring alone. This month’s newsletter is a review of the second study which demonstrates the value of the ForeseeHome Monitoring Program. “The Real-World Performance of a Self-Operated Home Monitoring System for Early Detection of Neovascular Age-Related Macular Degeneration” is the first study that looked at the performance of ForeseeHome in the real world and was published in 2021. Since this study was done outside of a clinical trial, it is referred to as a “real-world” study and reflects what patients experience.

The goal of this study was to determine if the results looking at patients monitored with ForeseeHome in the real world are as good as those in the original clinical trial in detecting the conversion of intermediate dry age-related macular degeneration (AMD) to the neovascular, or wet, form of AMD.

This study looked at all patients on the ForeseeHome Monitoring Program from October 2009 to September 2018. In this period there were 8,991 patients and 13,930 eyes enrolled and monitored. A total of 306 eyes converted from intermediate dry AMD to wet AMD during the study period. This was a conversion rate of 2.7% per monitoring year, which is typical for this population, and demonstrates that the patients being monitored were comparable to those patients with intermediate AMD who were not monitored. The study showed that 81% of eyes with a vision of 20/40 or better at the start of monitoring retained that vision at the time of conversion to wet AMD.

This is the first large scale study that validates the results of the original HOME Study in the real world. In the Real-World Study, patients tested more often at 5.6 times per week compared to the 4.4 times per week in the HOME Study. We know that testing often, up to once a day, gives patients the best chance of early detection of a conversion while vision is good. This is because the HOME Study showed that more frequent testing is associated with better vision acuity at conversion than testing less frequently.

The vision at the time of conversion in patients monitored with ForeseeHome was excellent at 20/40 or better in 81% of the patients being monitored. 20/40 or better vision is what we term functional vision. That is the ability to read, drive, see faces, and function daily. This can be compared with the 13.1% - 34% of eyes who had 20/40 or better vision at the time of conversion in other real-world studies where they were not participating in the ForeseeHome Monitoring Program.

We know from multiple studies that the best predictor of long-term vision after treatment for wet AMD is the vision at the start of treatment. Therefore it is of utmost importance to catch conversion to wet AMD while visual acuity is good.

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