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Dennis M Marcus, ; Long-term Follow-up of Intravitreal Aflibercept Injection (IAI) for Neovascular Age-Related Macular Degeneration (nAMD) in an Open-Label Extension of the VIEW1 Study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3943.
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To assess long-term safety of IAI in nAMD patients (pts) continuing in an open-label extension study after completing the phase 3 VIEW1 trial.
VIEW1 randomized 1217 pts to receive fixed dosing of either 0.5 mg ranibizumab every 4 weeks (wks), 2 mg IAI every 4 wks, 0.5 mg IAI every 4 wks, or 2 mg IAI every 8 wks after 3 monthly injections from baseline to week 52, followed by variable dosing of the originally assigned anti-VEGF dose with mandatory quarterly injections from weeks 52 to 96 (modified quarterly dosing). After completing VIEW1, pts were eligible for an open-label extension study to receive modified quarterly dosing of 2 mg IAI from week 96 to 192; treatment as often as every 4 wks was allowed. Pts were monitored monthly in VIEW1 and at least quarterly in the extension study. The primary and secondary objectives of the extension study were the assessment of long-term safety and BCVA, respectively.
The extension study enrolled 323 pts with a mean BCVA of 55.6 letters at the VIEW1 baseline, and 65.8 letters at the extension baseline. Extension pts received a mean (range) of 9.6 (0-25) injections during wks 96-192. At week 96, patients had gained a mean of 10.2 letters from the VIEW1 baseline, which was largely maintained by week 192 with a mean gain of 7 letters from the VIEW1 baseline. The proportion of patients who gained ≥0 and ≥15 letters from the VIEW1 baseline was 83% and 37% at week 96, and 72% and 30% at week 192, respectively. At week 96, 11% and 5% of patients and at week 192, 20% and 8% of patients lost ≥5 and ≥15 letters from the VIEW1 baseline, respectively. The most common serious ocular adverse events were retinal hemorrhage (0.6%) and reduced visual acuity (0.6%) during the extension study; the overall incidence of APTC-defined arterial thromboembolic events was 5.3%. The incidence of intraocular inflammation and endophthalmitis was low (13 and 1 in 3093 injections [0.42% and 0.03%], respectively).
Visual gains achieved with anti-VEGF therapy during 2 years of VIEW1 were largely maintained by continued treatment with IAI 2 mg over a period of 2 years in the extension study. Anti-VEGF injections (including 4 years of IAI 2 mg) were well-tolerated during long-term follow-up with no new safety signals compared to known profile of IAI.
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