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The following is a summary of “Ethnoracial Representation in U.S. Clinical Trials for Retinal Vein Occlusion,” published in the April 2025 issue of American Journal of Ophthalmology by Chang et al. 

Retinal vein occlusion (RVO), the second leading cause of vision loss from retinal vascular disease, has been underrepresented in clinical trials, affecting the external validity and equity of the results.  

Researchers conducted a retrospective study to analyze the evolution of ethnoracial demographic reporting, changes in the racial and ethnic composition of RVO trial participants, and associations with trial sponsor and collaborator types.  

They examined the ethnoracial distribution of participants, sponsors, and collaborators in United States (U.S.)-based RVO clinical trials. Data was collected from ClinicalTrials.gov and compared with the 2022 U.S. Census Bureau data to assess changes in ethnoracial reporting and trial representation.  

The results showed that racial data was missing for 12.2% (6/49) of trials completed between 2008 and 2011. Ethnoracial reporting increased significantly from 20.7% (6/29) in 2012–2017 to 92.9% (13/14) in 2017–2022 (OR 49.8; 95% CI: 5.39–460.47; P <0.0001). The proportion of Asian participants grew from 4.2% to 15.9% (OR 4.37; 95% CI 2.49–8.37; P <0.0001), and Black participants increased from 6.1% to 20.7% (OR 4.03; 95% CI 2.51–6.85; P <0.0001). Conversely, White participants decreased from 73.8% to 56.0% (OR 0.45; 95% CI 0.34–0.59; P <0.0001), and Hispanic/Latino participants decreased from 13.1% to 5.4% (OR 0.38; 95% CI 0.26–0.56; P <0.0001). Compared to the 2022 U.S. Census data, the RVO trial enrollment had significant ethnoracial differences (P <0.0001). Government and academic involvement correlated with lower White representation and higher Black representation (P ≤0.01).  

Investigators concluded that the documentation of racial and ethnic demographics in RVO clinical trials increased between 2008 and 2022, and the recruitment of Asian and Black patients improved, while the Hispanic population remained underrepresented. 

Source: ajo.com/article/S0002-9394(25)00183-7/fulltext