Personalized Treatment Supported by Automated Quantitative Fluid Analysis in Active Neovascular Age-Related Macular Degeneration (nAMD)—a Phase III, Prospective, Multicentre, Randomized Study: Design and Methods

AI Generated Summary*

Methods are set out for a planned phase III multicentre trial of AI-based OCT fluid quantification to guide anti-VEGF retreatment in active neovascular AMD. Across nine sites, 290 patients with foveal intraretinal or subretinal fluid will be randomized 1:1 to pro re nata care informed by automated volume measurements or by conventional qualitative judgement of fluid presence. Retreatment in the quantitative arm is planned when central millimetre fluid exceeds 10 nl or, where volumes persist above that level, rises by more than half. Either arm also retreats for a five letter loss attributed to neovascular activity or fresh haemorrhage. Mean injections over one year is the primary endpoint, visual acuity secondary; sizing assumes at least 8.5 injections without AI.

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