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. 2023 Jul 21;12(5):2323–2346. doi: 10.1007/s40123-023-00768-z
We identified 12 randomised, controlled clinical trials investigating treatment of neovascular age-related macular degeneration with anti-vascular endothelial growth factor treatments using a proactive treatment regimen.
Disease activity criteria were visual acuity change in 6 trials; 4 included macular thickness change; 1 trial included visual acuity change if associated with macular thickness change; 1 with qualitative optical coherence tomography (OCT) features; 4 with qualitative OCT features if also associated with visual acuity change; 10 with macular haemorrhage and 5 with other fluorescein angiographic features. Meaningful comparison of secondary outcomes relating to treatment durability across clinical trials, such as the proportion of eyes with macular fluid or extended treatment intervals at time points, can therefore not be made.
New approaches to clinical trial disease activity criteria are needed to help generalisability of findings to real-world settings and allow better comparison of treatment durability outcomes across clinical trials and real-world settings.