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Swetha Bindu Velaga, Muneeswar Gupta Nittala, Jyotsna Maram, Thomas A Ciulla, Michael S Ip, Srinivas Sadda; Area of Disorganization of the Retinal Inner Layers (DRIL) as a Quantitative Biomarker in Eyes with Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2020;61(7):4859.
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© ARVO (1962-2015); The Authors (2016-present)
To determine the relationship between the area of disorganization of retinal inner layers (DRIL) over time and visual acuity in eyes with diabetic macular edema (DME).
The TYBEE Study was a multicenter, randomized, masked, controlled Phase 2 trial (NCT03126786) comparing suprachoroidal (SC) CLS-TA + aflibercept (combination therapy arm) vs. aflibercept (monotherapy arm) for the treatment of DME. All subjects signed written informed consent (IRB approved) and were randomized 1:1 to combination (n =36) or monotherapy (n = 35) at baseline. Patients were receive either quarterly treatments of suprachoroidal CLS-TA together with intravitreal aflibercept (months 0 and 3) (combination arm) or four monthly treatments of intravitreal aflibercept plus a sham suprachoroidal procedure (months 0, 1, 2 and 3) (control arm), with patients in either arm receiving intravitreal aflibercept treatment at months 4 and 5 as needed. Volume OCT scans using Spectralis (20°X20° scan with 49 B-scans) were obtained at baseline and week 24 and transmitted to the Doheny Image Reading Center (DIRC) for assessment. DRIL was defined in accordance with previously published criteria, as a region of loss of the normal inner retinal lamination. The regions of DRIL were manually segmented on all B-scans in the volume at baseline and week 24 using DIRC OCT analysis (OCTOR) software. The area of DRIL and greatest linear dimension (GLD) of DRIL (along a B-scan) were computed.
At baseline, the GLD and area of DRIL were 2004 µm and 3.9 mm2, and 3200 µm and 4.9 mm2 in the combination and monotherapy arms, respectively. By week 24, the GLD of DRIL decreased by -736.2 µm and -782.2 µm (p = 0.85 – no difference between arms) and the DRIL area decreased by -2.2 mm2 and -3.6 mm2 (p = 0.35) in the combination and monotherapy arms, respectively. The area of DRIL was correlated with BCVA at baseline, and post-treatment reduction in the area of DRIL was correlated with improvement in BCVA. Of note, while area of DRIL was modestly correlated with change in BCVA (r = 0.29, p = 0.03), the GLD of DRIL (r = 0.07, p = 0.62) was not.
The extent of DRIL appears to decrease following treatment of DME. Area of DRIL correlates better with visual function than the linear extent of DRIL, and may be a useful quantitative biomarker in future studies of diabetic macular edema.
This is a 2020 ARVO Annual Meeting abstract.
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