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Ursula Schmidt-Erfurth, Hrvoje Bogunovic, Thomas Schlegl, Amir Sadeghipour, Sebastian M Waldstein, Bianca Gerendas; Prognostic factors in the treatment of diabetic macular edema (DME) using aflibercept, ranibizumab and bevacizumab (DRCR.net protocol T). Invest. Ophthalmol. Vis. Sci. 2016;57(12):2082.
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© ARVO (1962-2015); The Authors (2016-present)
Anti-VEGF therapy has been established as the gold standard in the treatment of diabetic macular edema (DME) achieving improvement in best corrected visual acuity (BCVA) as well as reduction of central retinal thickness (CRT). The consecutive aim is to optimize treatment outcomes and disease management by identification of prognostic features and substance characteristics. Advanced analyses of optical coherence tomography (OCT) images using computational methods allows to deduct prognostic factors.
Post-hoc analyses were conducted in randomized trial data from 629 individuals with DME involving the center of the macula and BCVA from 78 to 24 ETDRS letters. Participants were randomized 1:1:1 to receive intravitreal therapy with aflibercept (2.0 mg), ranibizumab (0.3 mg) or bevacizumab (1.25 mg) according to a protocol-specified, as needed regimen. Spectral-domain OCT images were analyzed using automated algorithms for fluid quantification and retinal layer segmentation. CRT was measured in µm, intraretinal cystoid fluid (IRC) and subretinal fluid (SRF) were measured as volume in mm3 within the central 3 mm of the macula at baseline, weeks 4,8,12, and 24. Predictive computerized modeling was used for ranking of the most important predictive features for BCVA.
Baseline CRT and baseline IRC volume showed a moderate correlation with BCVA at baseline which declined over weeks 24 and 52. Using modeling, IRC in the outer nuclear layer temporal to the fovea seemed to have the greatest predictive value. SRF had no relevant prognostic value for BCVA outcomes. The IRC volume at week 4 was already predictive of BCVA outcomes up to week 52 with a difference of +3 letters. Persistent IRC beyond month 3 was a poor prognostic factor. Aflibercept was most efficient in reducing IRC volumes and superior to ranibizumab/bevacizumab from week 24 which translated into superior BCVA gains. These prognostic findings were identical for the overall group as well as for eyes with a baseline BCVA < 69 ETDRS letters.
From treatment initiation, IRC volume appears to be the most relevant predictive factor determining BCVA gains. An anti-VEGF substance having an effect on rapid IRC reduction enhances the benefit. Automated algorithms and predictive modeling offer promising tools to identify predictive factors.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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