Characteristics of Participants in Diabetic Retinopathy Clinical Research Clinical Trials Who Were Lost to Follow up
Theodore Bowe, Raziyeh Mahmoudzadeh, Rebecca R. Soares, Michael K. Nguyen, Jason Hsu, Ajay E. Kuriyan- Ophthalmology
- General Medicine
Abstract
Purpose:
Our study describes the racial/ethnic composition and the broad health status/severity of disease of the cohorts of Diabetic Retinopathy Clinical Research (DRCR) clinical trials and compares the rates of non-completion of the trial to the first data report (lost to follow up (LTFU)).
Methods:
This study is a retrospective cohort study of participants in Diabetic Retinopathy Clinical Research (DRCR) Retina Network clinical trials that met our inclusion criteria.
The primary outcome was the lost to follow up rates and their associated risk factors.
Results:
Eight clinical trials with 3492 participants met our inclusion criteria. Participants who were LTFU were more likely younger, Hispanic or Black, Type 1 DM, worse baseline BCVA, higher HbA1c, higher BP, and had PDR (Diabetic Retinopathy Severity Score >66).
Conclusions:
Participants who were LTFU during DRCR clinical trials tended to be younger, Hispanic or Black, and have worse diabetes and hypertension. This study highlights the importance of ensuring a representative population is maintained through the end of the study period.