Epivascular Glia and Macular Pigment Changes after Faricimab or Aflibercept during the Loading Phase in Diabetic Macular Edema: A Prospective Non-randomized Pilot Study.

Purpose

To explore short-term changes in epivascular glia (EVG), macular pigment optical density (MPOD), visual acuity, and retinal thickness after faricimab or aflibercept in treatment-naive eyes with center-involving diabetic macular edema (DME).

Methods

This prospective, non-randomized pilot study included 30 eyes with DME and EVG on en face optical coherence tomography. Fifteen eyes received three monthly injections of faricimab 6 mg and 15 received aflibercept 2 mg. The primary exploratory outcome was complete EVG regression after loading. Secondary outcomes included best-corrected visual acuity (BCVA), central macular thickness (CMT), MPOD, fluid resolution, and resolution of traction-related abnormalities.

Results

Complete EVG regression occurred in 12/15 eyes (80.0%) with faricimab and 6/15 (40.0%) with aflibercept (Fisher's exact p=0.060). Resolution of traction- related abnormalities occurred in 11/15 (73.3%) and 5/15 eyes (33.3%), respectively (p=0.066). Post-loading CMT was 274.5 ± 61.3 versus 328.7 ± 72.4 µm (unadjusted p=0.035), MPOD was 0.46 ± 0.07 versus 0.39 ± 0.08 (unadjusted p=0.017), and BCVA was 0.27 ± 0.14 versus 0.36 ± 0.16 logMAR (p=0.112).

Conclusions

EVG and traction- related outcomes were numerically more favorable with faricimab but were not statistically significant. Exploratory anatomical and MPOD differences require confirmation in larger randomized studies.