Abstract
Purpose :
Diabetic macular edema (DME) leads to significant vision impairment among people with diabetic retinopathy (DR). Previous optical coherence tomography (OCT) studies have confirmed several retinal structural abnormalities including diffuse retinal thickening (DRT) in DME (Figure 1). We investigated the relationship between a DME phenotype DRT and visual function in the phase 2b Altimeter Trial (MR41926) using faricimab for DME.
Methods :
Eligible patients from the phase 2b Altimeter trial were evaluated at day 1, day 112 and day 140 study visits. Subjects underwent eye examinations including best-corrected visual acuity (BCVA) and Heidelberg Spectralis OCT imaging. DRT was manually evaluated for its presence or absence on a central horizontal B-scan by two expert graders. The overall association between DRT and BCVA was assessed using a linear mixed effect model where a random intercept was assigned for each subject to adjust for potential differences at baseline.
Results :
Among a total of 271 subjects across three study visits, DRT was present in 64.3% (63/98) subjects on day 1, 45.2% (38/84) subjects on day 112 and 27% subjects (24/89) on day 140. The inter-rater agreement (Fleiss kappa scores) for DRT was 0.79 (95% confidence interval (CI): 0.71 to 0.86) across all visits. In the longitudinal assessment from day 1 to day 140, the DRT phenotype showed an association with lower BCVA -9.4 (95% CI: -12.3 to -6.5).
Conclusions :
DRT phenotype is associated with vision loss among subjects with DME. Subjects with DRT had lower BCVA compared to subjects with no DRT. The proportion of patients with DRT (at the end of the study from baseline) was reduced by about 2.4 fold after treatment with faricimab. Further longitudinal studies in DME are required to quantify these retinal changes and their association with visual outcomes.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.