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Daniele Veritti, Federico Ugo Ricci, Valentina Sarao, Paolo Lanzetta; Twelve months outcomes of Intravitreal aflibercept for neovascular age-related macular degeneration. Fixed versus as needed dosing.. Invest. Ophthalmol. Vis. Sci. 2017;58(8):904.
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Aflibercept is a recombinant fusion protein targeting and inhibiting VEGF and its safety and efficacy in wet age-related macular degeneration (AMD) were shown in the VIEW trials with a fixed bimonthly regimen after three initial monthly injections. To our knowledge no studies have compared the clinical outcomes of aflibercept employed with a fixed schedule to a pro-re-nata (PRN) retreatment regimen. With this aim we designed and conducted the present study.
This was a retrospective, multicenter, non-inferiority, propensity score matched study evaluating the 12-month outcomes of aflibercept given either according to labelling (three monthly injections followed by bimonthly treatment) or following a PRN regimen. Patients included in the latter group received one initial injection followed by monthly visits and as-needed retreatment. Retreatment criteria were the same as those used in the CATT trial (vision loss of more than 5 ETDRS letters, presence of any fluid detected with OCT). The primary outcome measure was difference in mean ETDRS BCVA change between the two groups at month 12. Secondary outcomes measures included difference in mean CRT and BCVA changes, total number of treatments and visits, and safety profile.
Ninety-two eyes were enrolled in each group. Visual acuity improved from baseline to 12 months in both study groups (fixed group: +6.7 letters, PRN group: +1.9 letters). At month 4, the fixed regimen was equivalent to the PRN regimen (mean difference: 1.75 ETDRS letters, 95% CI: -1.42 +4.92). The PRN regimen failed to show non-inferiority compared to the fixed regimen at both month 8 (mean difference: 3.43 ETDRS letters, 95% CI: +0.25 +6.22) and month 12 (mean difference: 4.83 ETDRS letters, 95% CI: +1.37 +8.29). All patients in the fixed group received 7 injections and 4 visits during the study period. Patients included in the PRN arm received a mean of 5.5 ±1.6 treatments and 13 visits. No ocular nor systemic adverse events were recorded.
The present study showed that aflibercept given with fixed/proactive treatment regimen produced better visual acuity outcomes than PRN regimen, with a sustainable number of treatments and visits during the first year of therapy.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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