J Natl Med Assoc
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Evaluate racial and ethnic representation in clinical trials compared to the disease burden for diabetic retinopathy (DR) and diabetic macular edema (DME) within the United States (US). Diabetic retinopathy (DR) is currently the leading cause of blindness in American adults, affecting over 7.7 million individuals and disproportionately affecting Black Americans. Black patients represent 38.3 ± 16.5% of DME within the US population while White patients represented 44.6 ± 18.3% of the DME population in the US. ⋯ Black patients are under-represented by a 3.0-fold disparity in NIH trials and 4.5-fold disparity in industry trials for DME, while White patients are overrepresented. In industry-funded DR trials, there is a 2.1-fold disparity compared to disease burden. Clinical trials for diabetic eye disease should aim to recruit patients based on the disease burden, which enables measurements of treatment outcomes by race and promotes health equity.