Clinical trial outcomes for geographic atrophy provides valuable data from both patient and expert input

Research at the Centre for Public Health, Queen’s University Belfast, UK, has suggested that a core outcome set (COS) of measurements should be used in geographic atrophy (GA) trials.  The core outcome set of measurements are proposed to include patient-reported outcome measures, near visual acuity, reading speed and assessment of the outer retina.  According to a publication at the British Journal of Ophthalmology (2019;0:1–7), the researchers have stated that “meaningful, well-defined outcomes that are relevant to patients, clinicians and policy-makers are essential for designing clinical trials designed to guide clinical practice”.

 

The Belfast study used a five-component project including a Delphi methodology with patients and experts using focus groups and interviews with patients, relatives and workers supporting geographic atrophy patients. The study recruited 301 patients.  Following the data and analysis the researchers identified core outcomes including the health of the outer retina, measurements of multimodal estimation of lesion size, reading speed, best corrected distance and near acuity, low luminance visual acuity and patient reported visual performance and safety.  According to the review, the most important outcomes identified by both patients and experts were safety measures (safety profile, defects of a study eye and health of the other eye), retinal imaging, reading speed (RS) and near visual acuity (NVA). Quality of Life (QoL) measures were identified important to both groups, referenced to a median score of 8 given by the expert group.

 

As outlined in the paper, the very valuable summary stated that, “using two Delphi consensus exercises, one with patients and another with experts, and interviews with patients, relatives, and allied health professionals, we have identified a set of core outcomes for GA trials: anatomical (outer retina and size of GA lesion), reading speed, near, distance and low luminance visual acuity, safety and visual function-related QoL. We also identified other key elements of GA core outcomes such as a minimum timeframe (24 months), specific metric (change from baseline) and testing modalities. These findings have the potential to help reduce the variability previously observed in outcome selection in GA trials”.

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