Abstract
Purpose
To evaluate disorganization of retinal inner layers (DRIL), as detected on spectral-domain
optical coherence tomography (OCT) images, as a biomarker for diabetic macular edema
(DME) activity, visual function, and prognosis in eyes with DME.
Design
Longitudinal prospective.
Methods
Post hoc correlation analyses were performed on data from a phase 2 clinical trial.
Seventy-one eyes of 71 patients with treatment-naive DME received either suprachoroidally
administered CLS-TA (proprietary formulation of a triamcinolone acetonide injectable
suspension) combined with intravitreal aflibercept or intravitreal aflibercept with
a sham suprachoroidal injection procedure. DRIL area, maximum horizontal extent of
DRIL, ellipsoid zone (EZ) integrity, and the presence and location of subretinal (SRF)
and intraretinal fluid (IRF) were evaluated at baseline and week 24 by certified reading
centre graders.
Results
At baseline, the area and maximum horizontal extent of DRIL were negatively correlated
with best-corrected visual acuity (BCVA; r = –0.25, p = 0.05 and r = –0.32, p =0.01, respectively). Mean baseline BCVA progressively worsened with each ordinal
drop in EZ integrity, improved with the presence of SRF, and was invariant to the
presence of IRF. DRIL area and maximum extent were significantly decreased at week
24 (–3.0 mm2 [p < 0.001] and –775.8 mm [p < 0.001], respectively. At week 24, decreases in the area and maximum horizontal
extent of DRIL were positively correlated with increases in BCVA (r = –0.40, p = 0.003 and r = –0.30, p = 0.04). Improvements in BCVA at week 24 were no different between patients showing
improvement in EZ, SRF, or IRF and those showing no improvement or worsening from
baseline.
Conclusions
DRIL area and DRIL maximum horizontal extent were demonstrated to be novel biomarkers
for macular edema status, visual function, and prognosis in eyes with treatment-naive
DME.
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Article info
Publication history
Published online: February 16, 2023
Accepted:
January 22,
2023
Received in revised form:
December 15,
2022
Received:
July 25,
2022
Publication stage
In Press Corrected ProofFootnotes
Portions of the data in this paper were presented at the 37th Annual Meeting of the American Society of Retina Specialists, Chicago, IL., July 26–30, 2019, at the Annual Meeting of the American Academy of Ophthalmology, San Francisco, CA, October 12–15, 2019, and at the 43rd Annual Virtual Meeting of the Macula Society, February 19–22, 2020.
Identification
Copyright
© 2023 Published by Elsevier Inc. on behalf of Canadian Ophthalmological Society.
