Table 4.
Intra-group and inter-group comparison of BCVA during the study period
| Dataset | Change in BCVA (mean ± SD) | |||
|---|---|---|---|---|
| Visit 1 → Visit 5 | Visit 5 → Visit 14 | Visit 1 → Visit 14 | ||
| ITT | IVOM | 4.11 ± 6.31 (p = 0.087) | 2.86 ± 5.08 (p = 0.187) | 5.86 ± 1.86 (p < 0.001) |
| IVOM+Laser | 4.30 ± 6.96 (p = 0.083) | 5.00 ± 4.74 (p = 0.009) | 9.30 ± 5.12 (p < 0.001) | |
| IVOM vs. IVOM+Laser | p = 0.952 | p = 0.387 | p = 0.075 | |
| PPS | IVOM | 5.00 ± 6.88 (p = 0.242) | 0.25 ± 5.12 (p = 0.928) | 5.25 ± 2.06 (p = 0.015) |
| IVOM+Laser | 4.00 ± 7.29 (p = 0.165) | 5.50 ± 5.21 (p = 0.020) | 9.50 ± 5.26 (p = 0.001) | |
| IVOM vs. IVOM+Laser | p = 0.824 | p = 0.129 | p = 0.158 | |
ITT intent-to-treat set (all randomized subjects); PPS per-protocol set (subjects with complete data of primary and secondary target variables at the first and last visit, with no major protocol deviations); BCVA best corrected visual acuity;
Comparisons between groups were done using Student’s t-test for dependent samples. BCVA changes are expressed in ETDRS charts for better statistical analysis