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Maziar Lalezary, David Sarraf, Prema Abraham, Steven G Lin, Clement K Chan, ; The EVEN Study: An In-depth Prospective Trial on Intravitreal Aflibercept Treatment of Submacular Vascularized Pigment Epithelial Detachment. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3969.
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This multi-center open-label investigator-initiated reports in-depth quantitative and qualitative assessment of lesion components by a reading center (Doheny Image Reading Center) on eyes with submacular vascularized pigment epithelial detachment (vPED) treated with aflibercept, including lesion volumetrics.
Treatment naïve eyes with vPED of ≤ 12 disc areas (DA) and ETDRS VA from 20/40 to 20/400 were enrolled for prospective assessment of lesion components and vision outcome from baseline to 12 months (M). All study eyes were to receive 6 monthly (QM) 2.0 mg aflibercept injections and followed by 3 bimonthly injections. Additional 3 injections were allowed one month after last injection on a pro re nata basis during second 6M. ETDRS VA and OCT were performed at baseline and QM. FA was done at baseline, 3M, 6M, 12M; ICG at baseline & 3M. All images were assessed in detail by reading center. This is a 6M interim report on 11 patients. Lesion components assessed included PED, choroidal neovascularization (CNV), subretinal fluid (SRF), retinal tissue, and subretinal tissues (SRT) (CNV, fibrin, fibrosis, lipid, hemorrhage).
Eleven eyes (E) of 11 patients included in baseline (pre) and 6M (post) assessment had mean age of 79.0 (7 women, 4 men) and mean pre and post ETDRS VA of 20/65 and 20/46.There were 6 pseudophakic and 6 left E. Mean pre and post PED surface area (SA) and greatest linear diameter (GLD) were 6.4±4.6 mm2, 3.4±1.9 µm and 1.5±2.6 mm2, 0.9±1.5 µm (p=0.03, 0.02, respectively paired-t). Mean pre and post CNVSA were 7±4.4 mm2 and 2.6±2.7 mm2(p=0.02, paired-t). Mean pre OCT-measured height (Ht)(µm) and volume (Vol)(mm3) were PED (378.2,1.4), SRF (20.3,0.7), SRT(15.4, 0.5), retina (272.6, 9.2). Mean post Ht and Vol were PED (269.7, 0.5), SRF (2.3, 0.08), SRT (4.6, 0.2), retina (262.4, 8.9). Significant reduced post lesions included retinal Ht and SRT Ht and Vol (p=0.02, 0.04, paired-t, respectively).A trend for reduced PED and SRF Ht & Vol was noted. RPE tears formed in 2E, PVD in 2E, atrophy in 3E.
vPED eyes developed progressive reductions in dimensions, including volumetrics with stable vision at 6M after treatment with aflibercept. RPE tears developed in 2E and atrophy in 3E.This prospective report provides a plethora of information on characteristics of vPED following aflibercept treatment.
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