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Michael Singer, ; Long-term Visual Outcomes by Baseline Subgroup Characteristics of Intravitreal Aflibercept Injection for Neovascular Age-Related Macular Degeneration after the VIEW1 Study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4607.
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© ARVO (1962-2015); The Authors (2016-present)
Assess long-term visual outcomes in subgroups of patients (pts) receiving intravitreal aflibercept injection (IAI) in neovascular age-related macular degeneration who continued in an open-label extension study after the phase 3 VIEW1 trial.
VIEW1 randomized 1217 pts to receive fixed dosing of 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 wk 52, followed by modified quarterly injections from wks 52 to 96 of the originally assigned anti-VEGF dose. After completing VIEW1, pts were eligible for an open-label extension study to receive 2 mg IAI by modified quarterly injections followed by fixed every 8 wks dosing after a study amendment. Week 212 visual outcomes based on subgroup characteristics at VIEW1 baseline were analyzed. Subgroups included patients in the age groups: <65 years, 65-74 years, 75-84 years, and ≥ 85 years and patients with best-corrected visual acuity (BCVA) of ≥ 50 letters and <50 letters at VIEW1 baseline.
The extension study enrolled 323 pts with a mean BCVA of 55.6 letters at the VIEW1 baseline, and 65.3 letters at the extension baseline (wk 96). Mean BCVA at wk 212 was 61.7 letters. When grouped by age, mean BCVA was 59.3, 56.7, 55.9, and 51.2 letters at VIEW1 baseline for age subgroups <65, 65-74, 75-84, and ≥ 85 years, respectively. The mean change in BCVA at wk 212 from VIEW1 baseline was 7.9, 10.5, 6.4, and 3.2 letters for age subgroups <65, 65-74, 75-84, and ≥ 85 years, respectively. Mean BCVA was 61.3 and 37.5 letters at VIEW1 baseline and 66 and 52.3 letters at wk 212 in the ≥50 and <50 letters subgroups, respectively. The most common serious ocular AEs were endophthalmitis (0.9%) and retinal hemorrhage (0.6%) during the extension study.
Visual gains achieved with anti-VEGF therapy during VIEW1 were largely maintained by continued treatment with IAI 2 mg in the extension study. On average, patients who were ≥ 85 years had a poorer baseline VA upon entering VIEW1 and did not achieve the same level of VA gains nor maintain their mean VA gain at wk 212 compared to younger subgroups. Patients with VA < 50 letters at VIEW1 baseline gained more letters than those who enrolled with better VA.
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