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. 2020 Dec 14;61(14):12. doi: 10.1167/iovs.61.14.12

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Copyright 2020 The Authors

This work is licensed under a Creative Commons Attribution 4.0 International License.

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Figure 1. — Effect of subcutaneous AKB-9778 15 mg twice daily on IOP, in two consecutive clinical studies, TIME-2 and TIME-2b, in ocular normotensive patients with diabetic eye disease. Panels A to C represent data from the TIME-2 study. Panel (D) shows data from the TIME-2b Study. (A) In TIME-2, a consistent reduction from baseline (mean change from baseline ± standard error) is seen in both AKB-9778 groups, which was statistically significant in both groups and both eyes (study eye and fellow eye) at every time point with the exception of the AKB-9778 + sham group at 4 weeks. * P ≤ 0.05; ** P ≤ 0.01; *** P ≤ 0.005. (B) TIME-2 patient level IOP (average of both eyes, study and fellow eye, within each patient) expressed as mean change from baseline over time in all patients receiving AKB-9778, patients receiving AKB-9778 + sham, patients receiving AKB-9778 + Lucentis, and patients receiving placebo + Lucentis. The IOP differences from baseline (P ≤ 0.001 for all AKB-9778 treated groups) and from placebo (P = 0.005 for all patients receiving AKB-9778; P = 0.017 for AKB-9778 + sham; P = 0.013 for AKB-9778 + Lucentis) were statistically significant (MMRM ANCOVA). (C) TIME-2 patient level IOP change from baseline as a function of baseline IOP (< 16, ≥ 16, or ≥ 18; placebo adjusted mean ± standard error). Higher baseline IOP was consistently associated with larger IOP reduction consistent with decreased resistance in the pressure-dependent conventional outflow pathway. (D) TIME-2b patient level IOP (average of both eyes, within each patient) mean change from baseline over time in all patients receiving AKB-9778 15 mg QD (blue line), AKB-9778 15 mg BID (red line), and placebo (grey line). The IOP change from baseline was statistically significant for the AKB-9778 QD (P = 0.041) and BID (P < 0.0001) treatment groups, but not for the placebo group (P = 0.502). The mean reduction in IOP in the AKB-9778 BID group compared to placebo was 1.15 mm Hg (P = 0.0002) and in the AKB-9778 QD group was 0.70 mm Hg compared to placebo (P = 0.0552; MMRM ANCOVA).