False Positive Neovascular AMD Results May Foretell Future Conversion

When a patient with previously diagnosed neovascular age-related macular degeneration (nAMD) in 1 eye records a false negative in the fellow eye, it may actually be predictive of future conversion, a study published in Ophthalmology Retina suggests. Patients who routinely monitor their vision with ForeseeHome^® (Notal Vision) and experience a false positive in the undiagnosed eye are at high risk for future conversion, according to the research. 

Researchers hypothesize that, based on the outcomes of a ForeseeHome alert and the status of a fellow eye, home monitoring can identify a subgroup of eyes that are at elevated risk for future conversion. To test this hypothesis, the researchers conducted a retrospective review of records of all patients with intermediate dry AMD (iAMD) included in the Analysis of the Long-term Visual Outcomes of ForeseeHome Remote Telemonitoring (ALOFT) study, a retrospective analysis of the 10-years of visual acuity outcome data of patients participating in the ForseeHome program.

The study included all home monitored eyes that had a ForeseeHome alert, and conversion to nAMD was not detected within 1 month after the alert, indicating a false positive alert. For each of these eyes, the researchers obtained the iAMD vs nAMD status of the fellow eye at enrollment and eventual outcomes, including date of detection of conversion by the clinician and initiation of treatment or the date of the study final follow up visit without a conversion.

A total of 3334 eyes of 2123 participants were included in the ALOFT study. Of those, the researchers found that 29% of eyes (n=953) had a false positive alert. Among them, 53% of eyes fellow to nAMD later converted (56/106) and 13% of eyes fellow to iAMD were fellow to iAMD and later converted (110/847). 

The researchers also reconstructed approximate timing of conversions from ALOFT, and the PROCON (ClinicalTrials.gov Identifier: NCT02462889) and PREVENT (ClinicalTrials.gov Identifier: NCT02140151) studies, which were both designed to enroll eyes at high risk for conversion, using Kaplan-Meier (K-M) survival analysis. When comparing the false-positive nAMD fellow eyes to false-positive iAMD fellow eyes, baseline nAMD fellow eyes, and baseline iAMD fellow eyes from ALOFT, PROCON, and PREVENT, the researchers found significant differences in the K-M conversion functions (P <10^-6; P =.044; P <10^-6; P =.00004; and P =.00028, respectively). 

“We found that a false positive alert of eyes fellow to nAMD eyes has high predictive value for future conversions. These eyes may be candidates for prophylactic treatment studies, should be followed closely and counseled to comply with daily home monitoring,” according to the researchers.

Limitations of the study included the retrospective design, comparison of the results with published, not raw, data from other studies, and recognition of a conversion based on initiation of treatment, not on standardized imaging and interpretation.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.