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Jeffrey Marx, Darius Moshfeghi, Seenu Hariprasad, Jeffrey Heier, VIEW Study Investigators; Correlation Between Fluid Status at Week 12 and Week 52 Following Intravitreal Aflibercept Injections in the VIEW Study of wAMD Patients. Invest. Ophthalmol. Vis. Sci. 2013;54(15):6278.
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To determine the proportion of patients with and without fluid at week 12, one month after three initial doses of intravitreal aflibercept injections (IAI). To determine if fluid status at week 12 was associated with fluid status at week 52 and whether BCVA at week 52 was influenced by fluid status at week 12.
A total of 2457 patients with age-related macular degeneration were randomized to four treatment groups: IAI 2 mg every 4 weeks (2q4), 0.5 mg every 4 weeks (0.5q4), 2 mg every 8 weeks (2q8, after three initial monthly doses), or ranibizumab 0.5 mg every 4 weeks (Rq4). “No fluid” was defined as the absence of both cystic retinal edema and subretinal fluid. Relative risks of various events were computed using Rq4 as the control group.
Compared with Rq4, the relative risks (95% CI) of having retinal/subretinal fluid at week 12 were 0.74 (0.63-0.88), 1.18 (1.03-1.36), and 0.80 (0.68-0.94) for 2q4, 0.5q4, and 2q8, respectively. In patients with fluid at week 12, the unadjusted relative risks (95% CI) of not having fluid at week 52 (compared to Rq4) were 1.34 (1.08-1.67), 1.07 (0.86-1.33), and 1.34 (1.08-1.66) for 2q4, 0.5q4, and 2q8, respectively, and the unadjusted percentages of those gaining 3 lines from week 12 to week 52 were 32%, 32%, 27%, and 30% in Rq4, 2q4, 0.5q4, and 2q8, respectively. Patients who had no fluid at week 12 were also likely to have no fluid at week 52: 80%, 85%, 79.2%, and 79% in Rq4, 2q4, 0.5q4, and 2q8, respectively. In patients who had no fluid at week 12, the unadjusted percentages of those gaining 3 lines from week 12 to week 52 were 31%, 32%, 34%, and 32% in Rq4, 2q4, 0.5q4, and 2q8, respectively. In this study, the most frequent ocular adverse events in the study population were conjunctival hemorrhage, eye pain, retinal hemorrhage, and reduced visual acuity.
Compared to Rq4, patients treated with IAI 2 mg were less likely to have fluid at week 12. IAI patients with fluid at week 12 were more likely than ranibizumab patients to be dry at week 52. There was no difference in BCVA between the wet and dry groups.
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