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Roxanne R Crosby-Nwaobi, Philip G Hykin, Sobha Sivaprasad; Real-world rapid mean visual acuity improvement in patients initiated on aflibercept therapy for treatment-naïve neovascular age-related macular degeneration (nAMD).. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4605.
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To estimate the real-world impact in a UK NHS patient population of the initial aflibercept loading phase on mean visual acuity and macula drying in treatment naïve nAMD patients.
Records of 250 consecutive patients with treatment-naïve nvAMD in at least one eye were retrospectively reviewed. The patients underwent a loading dose of three monthly intravitreal aflibercept injections followed by 8 weekly fixed dosing until stability was reached when a treat and extend approach was followed. The mean change from baseline in visual acuity at 8 and 16 weeks was assessed. The change in proportions of patients who achieved a visual acuity of i. ≥73; ii. 35-54; and iii. <35 ETDRS letters at 8 and 16 weeks was also evaluated to understand the impact of aflibercept on driving vision, moderate and severe visual impairment respectively. The impact of aflibercept on macula drying was defined as a proportion of patients with less than 300μm central subfield thickness at 8 and 16 weeks compared to baseline. Bivariate analyses were conducted using SPSS v21.
The mean gain in visual acuity at 8 and 16 weeks were 6.9±11.6 letters and 6.7±12.4 (p<0.001) respectively. There was no regression of visual acuity gain at 16 weeks, that is, 8 weeks after the follow-up regimen had moved from 4 to 8 weekly visits. At baseline, visual acuity was ≥73 letters in 9% increasing to 32% and 33% at both 8 weeks and 16 weeks respectively (p<0.001). 76% of patients had 35-54 letters in the affected eye at baseline, decreasing to 59% at 8 and 16 weeks (p<0.001). Visual acuity was <35 letters in 15% of eyes at baseline, decreasing to 10% and 8% respectively at 8 and 16 weeks (p<0.05). 47% of eyes presented with central subfield thickness of ≥300µm and this was significantly reduced to 10% and 13% at 8 weeks and 16 weeks respectively (p<0.001).
There is a rapid visual acuity improvement following initiation of aflibercept in treatment naïve eyes with nvAMD which is independent of baseline central subfield thickness. In the real world, intravitreal aflibercept therapy mirrors clinical trial results with a significant number of eyes achieving driving vision after 3 loading injections.
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