Objective
To determine whether home monitoring with ForeseeHome device, using macular visual field testing with hyperacuity techniques and tele-monitoring, results in earlier detection of age-related macular degeneration associated choroidal neovascularization (CNV), reflected in better visual acuity, when compared with standard care. The main predictor of treatment benefit from anti-vascular endothelial growth factor (VEGF) agents is the visual acuity at the time of CNV treatment.
Design
Unmasked, controlled, randomized clinical trial.
Participants
1970 participants, aged 53 to 90 years, at high risk of developing CNV were screened; 1520, mean age 72.5 years enrolled in the HOme Monitoring of the Eye (HOME) Study in 44 Age-Related Eye Disease Study2) clinical centers.
Interventions
1) Standard care arm: investigator-specific instructions were provided for self-monitoring vision at home followed by report of new symptoms to clinic. 2) Standard Care and Device arm: device provided with recommendation for daily testing. The device monitoring center received test results and reported changes to the clinical centers who contacted participants for examination.
Main Outcome Measures
The difference in best-corrected visual acuity scores between baseline and detection of CNV. The event was determined by investigators based on clinical exam, color fundus photographs, fluorescein angiography, and optical coherence tomography. Masked graders at central reading center evaluated the images using standardized protocols.
Results
763 participants were randomized to device monitoring and 757 to standard care, and followed for a mean of 1.4 years between July 2010-December 2013. At the pre-specified interim analysis, 82 participants progressed to CNV, 51 in the device arm and 31 in the standard care arm. The primary analysis achieved statistical significance with the participants in the device arm demonstrating a smaller decline in visual acuity with fewer letters lost from baseline to CNV detection (median (interquartile range [IQR]):−4 [−11.0, −1.0] letters) compared with standard care (median [IQR]:−9 [−14.0, −4.0] letters) (p=0.021), resulting in better visual acuity at CNV detection in the device arm. The Data and Safety Monitoring Committee recommended early study termination for efficacy.
Conclusions
Persons at high risk for developing CNV benefit from the home monitoring strategy for earlier detection of CNV development which increases the likelihood of better visual acuity results following intravitreal anti-VEGF therapy.