Abstract
Purpose :
To assess the relationship between early treatment response using intraretinal fluid (IRF) volume reduction at 1 month and one-year anatomical and visual outcomes in patients with diabetic macular edema (DME).
Methods :
Study eyes from 887 patients with DME from Phase 3 YOSEMITE (NCT03622580) and RHINE (NCT03622593) treated with faricimab or aflibercept were included in this exploratory analysis based on the availability of quantitative metrics. Measurements included IRF and subretinal fluid (SRF) volume, and total retinal, outer nuclear layer (ONL), and inner retinal thickness (RT) averaged over the entire 3-mm diameter ETDRS subfield. These were assessed at baseline, week 4, and week 52 by spectral domain optical coherence tomography, and analyzed via a deep learning-based segmentation model. The model was trained on an independent dataset of B-Scans from phase 2 BOULEVARD (NCT02699450), manually annotated by the Liverpool Ophthalmic Reading Centre. Ten percent of the independent dataset was held out for validation, with median Dice scores of 85% and 79% for IRF and SRF, respectively. Patients were separated into groups based on IRF volume reduction (<20%, 20-50%, >50%) at week 4 from baseline. Comparisons were made in fluid volumes, thicknesses, and best-corrected visual acuity changes from baseline across the groups.
Results :
At week 4, IRF volume was reduced by <20% in 242 patients, 20-50% in 248 patients, and >50% in 397 patients. At year 1, IRF volume decreased by 270, 378, and 410 nL, respectively; total RT decreased by 87, 110, and 122 µm, respectively; ONL thickness decreased by 48, 57, and 60 µm, respectively; inner RT decreased by 34, 46, and 55 µm. Changes in IRF volume, total retinal, ONL, and inner RT were nominally significant between the groups at 1 year when adjusting for baseline IRF (p<0.001; p<0.001; p=0.0026; p<0.001). There was no difference in SRF volume reduction from baseline between groups at 1 year. Patients with >50% IRF volume reduction at week 4 showed nominally greater letter gains at 1 year compared to those with less reduction (>50% 12.2 vs 20-50% 10.6 letters p=0.047; >50% 12.2 vs. <20% 8.2 letters p<0.001; adjusted for baseline IRF).
Conclusions :
Greater IRF volume reduction within 1 month correlates with improved one-year anatomical and visual outcomes in patients with DME. These findings suggest the importance of rapid fluid reduction for better long-term results.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.