The HOME Study
Over the past few years, the National Eye Institute (NEI), a division of the National Institutes of Health (NIH), has been conducting a secondary study to AREDS2 with ForeseeHome®. This study demonstrated that earlier detection of CNV could be achieved through home-monitoring strategies with ForeseeHome, with eyes achieving better levels of vision at the time of CNV detection when using ForeseeHome vs. standard care methods alone.
Study Objective and Design
The HOme Monitoring of the Eye (HOME) study was a collaborative effort from investigators of the AREDS2 study who conducted a secondary study that evaluated whether home monitoring using the ForeseeHome device detected CNV at better levels of vision compared to standard care methods.
The HOME study involved 44 centers and enrolled 1,520 participants with AREDS Category 3 and 4 dry AMD, subjects at risk for the progression to CNV, into the clinical trial. The study was a long-term (3 year), Phase 3, unmasked clinical trial that participants were randomized 1:1 into either the device group (ForeseeHome users) or standard care group. Standard care was defined by the investigator and may have included use of the Amsler grid.
The cohorts in the ForeseeHome arm were defined by the frequency with which participants used the device. The overall group represented the Intention to Treat (ITT) cohort, with this group further categorized to Per Protocol 1 (PP1) and Per Protocol 2 (PP2) cohorts.
|ITT||All participants, whether they were randomized to the device arm or standard care alone arm|
|PP1||Participants using the device at time of CNV detection, regardless of adherence|
|PP2||Participants who met the minimum use criteria of 2 tests per week in their study eye(s) before the CNV event|
|Standard Care||These participants received instructions that were investigator specific for self-monitoring of vision at home to detect progression of AMD, such as use of an Amsler grid|
Early Demonstration of Efficacy = Early End to HOME Study
The Data Safety and Monitoring Committee recommended that the HOME Study be terminated based on the positive finding that:
The demonstration of eyes at high risk of progression to CNV can be identified with significantly better levels of visual acuity when detected with ForeseeHome plus standard care vs. standard care alone at the interim analysis (approximately 80% of the planned sample size).
ForeseeHome: proven, positive clinical results in the HOME Study
The decrease in VA score at the time of CNV detection was at least 5 letters lower in the median decrease in best corrected visual acuity (BCVA) in the device arm compared with the standard care arm. This resulted in median acuity among the device users of 20/32, with 94% of eyes maintaining 20/40 or better vision at CNV when they used ForeseeHome at the recommended frequency.
At least 5 letters saved with ForeseeHome vs standard care alone
94% of ForeseeHome patients who used the device as directed and converted to wet AMD kept their functional vision vs only 62% of patients using other detection methods
The majority of CNV events were prompted by the ForeseeHome device or symptoms alone (home modalities) between scheduled office visits. Both home modalities – device or symptoms – were competing to become the “First modality to alert to CNV” within the device arm vs symptoms in the standard care arm.
CNV detection by home modalities in the ForeseeHome device arm resulted in a significantly smaller VA change from baseline (p=0.03) compared to the standard care arm.
Sensitivity in the HOME Study
Specificity in the Home Study
Only 24% (0.24/year) false-positive alerts per year were triggered with ForeseeHome. These 24% of dry AMD patients may have had a statistically significant change in vision as detected by the ForeseeHome device* that may be indicative of CNV. However, on the follow-up office visit, CNV may have been too early to detect by optical coherence tomography (OCT) or fluorescein angiography (FA).
On average, there is only one false-positive alert per patient every 4.2 monitoring years with ForeseeHome.
* A statistically significant change as detected by the ForeseeHome device is considered a change in a patient’s test results compared to a patient’s baseline testing results and a normative database of test results for AMD patients.
The Evolution in the Early Detection of the Progression to CNV with ForeseeHome
With proven, clinical results ForeseeHome shifts the paradigm for early detection of CNV. In the HOME study, individuals with dry AMD at risk for progression to CNV, the large majority (94%) were shown to maintain good, functional vision at the time of their CNV detection when using the ForeseeHome device as recommended. In multiple studies, including landmark studies such as CATT, patients who had a baseline VA of 20/40 or better at CNV diagnosis had better overall visual outcomes following anti-VEGF therapy compared to those patients who started anti-VEGF therapy at VA levels below 20/40.
With ForeseeHome, earlier detection of CNV has become a reality where Earlier detection of CNV + Earlier Treatment = Better Visual Outcomes provides AMD patients the best chance for preserving good, visual outcomes.
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