Fluctuations in central subfield thickness associated with worse visual outcomes in patients with diabetic macular edema in clinical trial setting.

Abstract Purpose : This study examines the relationship between fluctuations in central subfield thickness (CST) and visual acuity in patients with diabetic macular edema (DME) using data from two large clinical trials. Design : Clinical cohort study using post hoc analysis of clinical trial databases. Methods : Standard deviation (SD) of all recorded CSTs for each patient during the study period were used to quantify the fluctuations in CST. Patients from each protocol were grouped into quartiles based on the CST SD. Eyes with at least 3 CSTs and visual acuity (VA) at 1 year were included. The main outcome measures were VA at 1 and 2 years for each Protocol, stratified by SD quartile. Results : A total of 1,197 eyes were included in the analysis. There were significant VA differences based on CST SD quartile for both Protocols while adjusting for mean baseline VA, baseline CST, lens status, hemoglobin A1c, and treatment arm. At week 52 in Protocol T, the difference between the first and fourth quartiles was -1.61 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (95% CI, -3.52 to 0.30, p = 0.0986). At week 104: this difference was -3.59 letters (95% CI, -6.17 to -1.00, p = 0.0066). In Protocol V at week 52 the difference between the first and fourth quartiles was -3.04 letters (95% CI, -4.18 to -1.91, p Conclusion : Large fluctuations in CST may portend worse VA outcomes at the 2 year endpoint in patients with DME.