Table 1.
Mean BCVA and CRT at month 12
| Ranibizumab pooled | Sham | |
|---|---|---|
| N | 102 | 49 |
| BCVA (ETDRS letters) | ||
| Baseline | 60.2 ± 9.9 | 61.1 ± 9.0 |
| Mean average change from baseline to month 1 through month 12 | ||
| Average month 1 to month 12 | 68.0 ± 11.7 | 61.0 ± 13.9 |
| Average change from baseline | 7.8 ± 7.7 | −0.1 ± 9.8 |
| Comparison vs. sham | ||
| Difference in least squares means | 7.9 | — |
| 95% CI for difference | 5.0 to 10.9 | — |
| P value | <0.0001 | — |
| Mean change from baseline to month 12 | ||
| Month 12 | 70.5 ± 12.1 | 59.7 ± 17.3 |
| Change from baseline | 10.3 ± 9.1 | −1.4 ± 14.2 |
| Comparison vs. sham | ||
| Difference in least squares means | 11.9 | — |
| 95% CI for difference | 8.1 to 15.7 | — |
| P value | <0.0001 | — |
| CRT (μm) | ||
| Baseline | 455.4 ± 114.2 | 448.9 ± 102.8 |
| Month 12 | 261.2 ± 81.9 | 400.5 ± 139.2 |
| Comparison vs sham | ||
| Change from baseline | −194.2 ± 135.1 | −48.4 ± 153.4 |
| Difference in least squares means | −155.0 | — |
| 95% CI for difference | −195.4 to −114.6 | — |
| P value | <0.0001 | — |
| Categorized BCVA outcome, n (%) | ||
| Gain of ≥1 letters* | 92 (90.2) | 27 (55.1) |
| Gain of ≥10 letters* | 62 (60.8) | 9 (18.4) |
| Loss of ≥10 letters* | 5 (4.9) | 12 (24.5) |
| Gain of ≥15 letters† | 33 (32.4) | 5 (10.2) |
| Loss of ≥15 letters† | 3 (2.9) | 10 (20.4) |
Data are means ± SD unless otherwise indicated. Ranibizumab dose and by group data (A, B, and A + B) are presented in supplementary Tables 3 and 4 (available in an online appendix).
*P < 0.0001;
†P = 0.0001. (Test for treatment difference [ranibizumab vs. sham], Cochran-Mantel-Haenszel test is of “general association.” Stratified analysis includes baseline visual acuity [≤60 or >60 letters] and baseline CRT [≤400 μm or >400 μm].)