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Objectives IVAN and TANDEM are factorial randomised controlled trials (RCTs) of different treatment regimens for wet AMD, involving off-label use of bevacizumab. Safety data are being collected but, given follow-up visits every 4-8 weeks for up to 3 years and verbatim reporting, are difficult to collate. We have developed a database solution for the TANDEM trial to minimise duplicate adverse events or events without resolution dates, based on lessons learnt in the IVAN trial.

trials

Documentation of adverse events in non-commercial trials of intravitreal injection of anti-VEGF drugs to treat wet age-related macular degeneration (AMD)