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Clement K Chan, David Sarraf, Prema Abraham, Maziar Lalezary, Steven Lin, EVEN Study Group; Prospective Multimodal Analysis of Aflibercept treatment of Pigment Epithelial Detachment in Neovascular AMD: The Even Study.. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4598.
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© ARVO (1962-2015); The Authors (2016-present)
To prospectively study the visual and anatomical outcomes and detailed volumetrics of pigment epithelial detachments (PED) treated with aflibercept in eyes with neovascular AMD through in-depth analysis by a reading center.
This multicenter open-label investigator-initiated trial utilized complex multimodal assessment of lesion components and volumetrics by a reading center (Doheny Image Reading Center).Treatment naïve eyes with vascularized PED (vPED) were enrolled for prospective assessment of visual outcome and lesion components from baseline until 12 months (M).All study eyes received 6 monthly (QM) followed by 3 bimonthly intravitreal injections of aflibercept (2.0 MG). ETDRS visual acuity (VA) and detailed SD-OCT analysis were performed at baseline and QM. FA was performed at baseline,1,6,12M and ICG at baseline and 6M.In-depth analyses of PED height,volume(Vol) and surface area (SA) and choroidal neovascular membrane(CNV) SA were assessed at baseline and follow up.Complex volumetric analysis of subretinal fluid(SRF), retina,and subretinal hyperreflective (SRH) material was also performed.
The 40 patients (eyes) enrolled in study had mean age of 80.8 years and mean pre- and post-ETDRS VA of 57.4 letters (20/76) and 64.9 letters (20/52) at last visit,respectively(7.5 letters improvement, p=0.0003). Mean pre- vs post-PED SA and Vol were 6.3 vs 0.8 µm2 and 1.7 vs, 0.52 mm3 (p<0.001,< 0.002) respectively.Mean pre- vs post-CNV SA was 9.5 vs 3.7 mm2(p<0.001).Mean pre- vs post-retinal thickness and Vol were 278.8 vs 265.5 µm and 0.21 vs 0.01 mm3 (p=0.01,<0.001) respectively.Mean pre- vs post-SRF Vol was 0.6 vs 0.05mm3 (p=0.009).Mean pre- vs post-SRH thickness and Vol were 101.3 vs 14.0 µm and 0.08 vs 0.01 mm3 (p<0.001,<0.001) respectively. Adverse events included RPE tears in 5 eyes(12.5%),and RPE atrophy in 3 eyes (7.5%).
The EVEN study provides robust high-quality data through sophisticated volumetric analysis of vascularized PED in response to aflibercept therapy.vPED eyes developed progressive reductions in Vol and SA with marked visual improvement at 12M after aflibercept therapy.Marked reductions in both retinal and subretinal hyperreflective material thickness and Vol (p<0.001) appear to be reliable markers for treatment improvement for PED.There were few ocular complications and no systemic adverse events.
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