Results, ITT Primary endpoint: BCVA (letters) mean change from baseline (AUC) are shown in Table 11. Table 11. Primary endpoint: BCVA (letters) mean change from baseline (AUC) Study Sham 700 µg 350 µg 010 N 163 166 165 mean change 4.1 4.3 1.9 difference from Sham (95% 2.1 (0.4, 2.3 (0.5, 4.0) CI) 3.8) 011 N 188 181 185 mean change 2.9 2.9 2.0 difference from Sham (95% 0.8 ( 0.9, 0.7 ( 0.9, 2.4) CI) 2.4) Pooled: 700 µg difference from Sham: 1.4 letters, 95% CI (0.2, 2.6) Selected secondary endpoint: Percentage of patients with 15+ letter improvement in BCVA are shown in Table 12. Table 12. Selected secondary endpoint: Percentage of patients with 15+ letter improvement in BCVA Sham 700 µg 350 µg 010 N 163 166 165 n (%) 36 (22)* 31 (19) 22 (13) 011 N 188 181 185 n (%) 42 (22)* 33 (18)* 20 (11) statistically significantly different from Sham “*” The mean change from baseline, pooled data from Studies 010 and 011 is show in in Figure 7. Figure 7. Mean change from baseline, pooled data from Studies 010 and 011 Results, selected pre specified subgroup analyses Difference from Sham, BCVA (letters) mean change from baseline (AUC) are shown in Table 13.
Results, ITT Primary endpoint: BCVA (letters) mean change from baseline (AUC) are shown in Table 11. Table 11. Primary endpoint: BCVA (letters) mean change from baseline (AUC) Study 700 µg 350 µg Sham 010 N mean change difference from Sham (95% CI) 163 4.1 2.1 (0.4, 3.8) 166 4.3 2.3 (0.5, 4.0) 165 1.9 011 N mean change difference from Sham (95% CI) 188 2.9 0.8 ( 0.9, 2.4) 181 2.9 0.7 ( 0.9, 2.4) 185 2.0 Pooled: 700 µg difference from Sham: 1.4 letters, 95% CI (0.2, 2.6) Selected secondary endpoint: Percentage of patients with 15+ letter improvement in BCVA are shown in Table 12. Table 12. Selected secondary endpoint: Percentage of patients with 15+ letter improvement in BCVA 700 µg 350 µg Sham 010 N n (%) 163 36 (22)* 166 31 (19) 165 22 (13) 011 N n (%) 188 42 (22)* 181 33 (18)* 185 20 (11) “*” statistically significantly different from Sham The mean change from baseline, pooled data from Studies 010 and 011 is show in in Figure 7. Figure 7. Mean change from baseline, pooled data from Studies 010 and 011 Results, selected pre specified subgroup analyses Difference from Sham, BCVA (letters) mean change from baseline (AUC) are shown in Table 13.
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