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K Bailey Freund, Robert Vitti, Yuhwen Soo, Desmond Thompson, Namrata Saroj, Alyson J. Berliner, Majid Anderesi, Olaf Sowade, Rupert Sandbrink; Intraocular Pressure in Patients with Neovascular AMD Receiving Intravitreal Aflibercept Injection or Ranibizumab. Invest. Ophthalmol. Vis. Sci. 2012;53(14):2036.
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To evaluate change in intraocular pressure (IOP) in patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) receiving intravitreal aflibercept injection (IAI; also referred to as VEGF Trap-Eye) or ranibizumab (RBZ) for 1 year in two randomized, Phase 3 clinical studies (VIEW1, VIEW2).
A total of 2457 patients with AMD were randomized to four treatment groups: IAI 2 mg every 4 weeks (2q4wk), 0.5 mg every 4 weeks (0.5q4wk), 2 mg every 8 weeks (2q8wk, after three initial monthly doses), or RBZ 0.5 mg every 4 weeks (Rq4wk). In this subanalysis, incidence of changes in IOP >10 mm Hg from baseline and proportion of patients with IOP >21 mm Hg were analyzed. In addition, Kaplan-Meier methodology was employed to evaluate sustained (2 consecutive months) incidences of IOP >21 mm Hg.
All treatment groups were equally balanced at baseline with respect to variables associated with IOP. Proportions of patients at Week 52 in the Rq4wk, 0.5q4wk, 2q4wk, and 2q8wk groups with an increase of ≥10 mm Hg in IOP from baseline were 3.2%, 2.3%, 1.1%, and 2.3%, respectively. At Week 52, the corresponding proportions of patients with an IOP >21 mm Hg were 13.6%, 8.2%, 10.1%, and 8.0%. A similar trend was seen in the fellow eyes. Compared with Rq4wk, the IAI groups had a significantly lower incidence of first sustained IOP > 21 mm Hg by 52% (95% CI: 12%, 75%), 70% (95% CI: 40%, 87%), and 54% (95% CI: 15%, 76%) for the 2q4wk, 0.5q4wk, and 2q8wk regimens, respectively, during the 52 weeks of treatment. The proportions of patients initiating IOP-lowering interventions were low in all groups.
During the first year of the VIEW studies, incidences of IOP increase were low and similar among the IAI groups and were lower than those seen with RBZ.
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