BACKGROUND: The standard of care for neovascular age-related macular degeneration (nAMD) is repeated intravitreal injection with anti-vascular endothelial growth factor agents. Real world evidence suggests that some patients are undertreated, which might be linked with the retreatment decisions made by physicians. Therefore, this multicentre observational study aimed to investigate the extent to which enrichment of optical coherence tomography (OCT) images with segmentation information could influence and support disease activity assessment (DAA) in patients treated for nAMD. METHODS: Descriptive statistics were tabulated for the demographic and clinical characteristics and outcome variables. To assess the influence of automated OCT image enrichment with segmentation information on DAA, a generalised linear mixed model was employed. The degree of agreement in classification of disease activity across reviewers was assessed by Krippendorff's alpha. RESULTS: The odds estimate for DAA regarding enriched OCT images was 0.759 and for non-enriched OCT images 0.772. The OR for enriched versus non-enriched OCT images was 1.078 with a p value of 0.229. No difference in the odds of DAA between automated OCT image enrichment with segmentation and DAA was noted. Krippendorff's alpha coefficient was 0.416 for enriched and 0.402 for non-enriched OCT images. Thus, the inter-reviewer reliability/agreement was similarly low between enriched and non-enriched OCT images. CONCLUSIONS: OCT image enrichment did not appear to impact the likelihood of adequately detecting disease activity, nor did it have an impact on agreement between reviewers of images in this study. No new safety signals in products involved in the study were detected. TRIAL REGISTRATION NUMBER: NCT04662944.
Kortuem et al. (Mon,) studied this question.