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Purpose: Our study describes the racial/ethnic composition and the broad health status/severity of disease of the cohorts of Diabetic Retinopathy Clinical Research clinical trials and compares the rates of noncompletion of the trial with the first data report (lost to follow-up)., Methods: This study is a retrospective cohort study of participants in Diabetic Retinopathy Clinical Research Retina Network clinical trials who met our inclusion criteria. The primary outcome was the lost to follow-up rates and their associated risk factors., Results: Eight clinical trials with 3,492 participants met our inclusion criteria. Participants who were lost to follow-up were more likely to be younger, Hispanic or Black, had Type 1 diabetes mellitus, had worse baseline best-corrected visual acuity, had higher hemoglobin A1c, had higher blood pressure, and had proliferative diabetic retinopathy (PDR) (Diabetic Retinopathy Severity Score >66)., Conclusion: Participants who were lost to follow-up during Diabetic Retinopathy Clinical Research clinical trials tended to be younger, Hispanic or Black, and had worse diabetes and hypertension. This study highlights the importance of ensuring that a representative population is maintained through the end of the study period.

Subjects in diabetic macular edema clinical trials in the United States are disproportionately White and male, compared with the population undergoing treatment for diabetic macular edema., (Copyright © 2022 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To identify geographic and socioeconomic variables predictive of residential proximity to diabetic eye disease clinical trial locations., Design: Cross-sectional, retrospective study., Participants: De-identified census tract-level data from public datasets and trial-level data from ClinicalTrials.gov., Methods: Using public data from ClinicalTrials.gov, we identified all active interventional clinical trials in diabetic eye disease since 2017. After geolocating every trial site, we used an origin-destination cost-matrix to calculate the driving distance and travel time from the population-weighted United States census tract centroid to the nearest site. We then used public databases to identify census tract-level socioeconomic factors predictive of driving distance and time., Main Outcome Measures: Driving distance > 60 miles and time traveled > 60 minutes to the nearest clinical trial site., Results: In a multivariate model, driving distance of more than 60 miles had a significant association with rural versus urban location (adjusted odds ratio, 5.22; 95% confidence interval [CI], 3.75-7.26; P < 0.001), percentage of population at less than 200% of federal poverty level compared with the fourth quartile (first quartile: adjusted odds ratio, 0.40 [95% CI, 0.29-0.55]; second quartile: adjusted odds ratio, 0.60 [95% CI, 0.47-0.77]; third quartile: adjusted odds ratio, 0.76 [95% CI, 0.63-0.91]; P < 0.001) and the Midwest (adjusted odds ratio, 2.15; 95% CI, 1.13-4.07; P = 0.02), South (adjusted odds ratio, 2.71; 95% CI, 1.23-5.99; P = 0.01), and West (adjusted odds ratio, 3.01; 95% CI, 1.21-7.54; P = 0.02) regions as compared with the Northeast. Driving distance was associated with county-level prevalence of diabetes in the univariate model (odds ratio, 1.12; 95% CI, 1.06-1.19; P < 0.001), although it was nonsignificant in the multivariate model. Similar predictors were found for time traveled in minutes., Conclusions: Geographic maldistributions of clinical trial sites exist for diabetic eye disease in the United States. Those with higher travel burden are more likely to reside in a census tract that is rural, low income, and from areas outside the Northeast., (Copyright © 2020 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)