Community Optometrist-Led Monitoring of Quiescent Neovascular Age-Related Macular Degeneration: The FENETRE Randomized Clinical Trial.

Abstract

Hospital-based ophthalmology faces increasing demand for long-term monitoring of neovascular age-related macular degeneration (nAMD). Safe redistribution of routine monitoring to community clinicians is relevant to integrated community (primary)-secondary care models. To examine whether community optometrist-led monitoring of nAMD is noninferior to hospital-based monitoring for detecting disease activity requiring treatment. This multicenter, noninferiority randomized clinical trial was conducted from October 8, 2019, to January 31, 2024, at secondary centers (17 hospitals) and primary centers (60 community optometry practices) with 12-month follow-up. Statisticians were masked to patient grouping. Adults 55 years or older with quiescent AMD in at least 1 eye (and quiescent or nonneovascular disease in the other) were recruited at participating hospitals. Data analysis was performed from October 2024 to March 2025. Participants were randomized 1:1 to monitoring sessions once every 2 months in hospitals (control) or community practices (intervention). Trained and accredited optometrists performed optical coherence tomography imaging, clinical examination, patient management, and online reporting at each visit. The primary outcome (participant level) was a binary indicator of whether a false-negative clinical management decision occurred at any visit within 12 months (missed quiescent nAMD reactivation or new fellow-eye nAMD, adjudicated by a central reading-center reference standard). The noninferiority margin was a 10-percentage point absolute risk difference. Secondary outcomes were false-positive clinical management decisions, attendance adherence, visual acuity change, harms, loss to follow-up, suspicious classifications, and confirmation visit outcomes. Of 704 randomized participants, 635 (90.2%) completed at least 1 follow-up visit, including 287 at community practices (mean [SD] age, 80.6 [8.1] years; 236 [67.4%] female) and 348 at hospitals (mean [SD] age, 80.1 [8.5] years; 203 [57.3%] female). False-negative clinical management decisions occurred in 11 of 287 community participants (3.8%) vs 27 of 348 hospital participants (7.8%) (risk difference, -3.9 percentage points; 95% CI, -7.4 to -0.3 percentage points; P = .04; adjusted odds ratio, 0.51; 95% CI, 0.24-1.07; P = .08), meeting noninferiority. False-positive clinical management decisions occurred in 24 of 287 community participants (8.4%) vs 12 of 348 hospital participants (3.5%) (risk difference, 4.9 percentage points; 95% CI, 0.9-9.0 percentage points). Findings were consistent across per-protocol, cluster-adjusted, and relative risk sensitivity analyses. No adverse event-related withdrawals occurred. In this randomized clinical trial, community optometrist-led monitoring of quiescent nAMD was noninferior to hospital monitoring for detecting disease activity requiring treatment. These results provide evidence for its use in integrated clinical care models. ClinicalTrials.gov Identifier: NCT03893474.