Table 1.
Secondary efficacy endpoints measurements at week 52
| Endpoint at week 52 (analysis set) |
Treatment | n | Change from baseline, least square mean (SE) | Difference (SB11-RBZ) |
||
| Mean | SE | 95% CI (90% CI for BCVA) |
||||
| BCVA (letters)* (FAS) |
SB11 (N=351) | 309 | 9.8 (0.8) | −0.6 | 0.9 | −2.1 to 0.9 |
| RBZ (N=353) | 327 | 10.4 (0.7) | ||||
| CST (μm)† (FAS) |
SB11 (N=351) | 308 | −140.0 (4.5) | −14.9 | 5.3 | –25.3 to –4.5 |
| RBZ (N=353) | 327 | −125.1 (4.3) | ||||
| CRLT (μm)‡ (FAS) |
SB11 (N=351) | 308 | −161 (5.1) | −11.5 | 6.0 | −23.2 to 0.1 |
| RBZ (N=353) | 327 | −149.5 (4.9) | ||||
| CNV size (mm2)§ (FAS) |
SB11 (N=351) | 303 | −5.2 (0.3) | −0.6 | 0.3 | −1.2 to 0.1 |
| RBZ (N=353) | 313 | −4.6 (0.3) | ||||
| Endpoint at week 52 (analysis set) |
Treatment | n’ | Responders, n (%) | Adjusted difference (SB11-RBZ) |
|
| Adjusted difference (%) | 95% CI | ||||
| Participants who lost <15 letters in BCVA compared with baseline¶ (FAS) |
SB11 (N=351) | 309 | 299 (96.8) | −1.2 | −3.8 to 1.3 |
| RBZ (N=353) | 327 | 320 (97.9) | |||
| Participants who gained ≥15 letters in BCVA compared with baseline¶ (FAS) |
SB11 (N=351) | 309 | 107 (34.6) | −3.2 | −10.5 to 4.2 |
| RBZ (N=353) | 327 | 123 (37.6) | |||
| Participants with active CNV leakage¶ (FAS) |
SB11 (N=351) | 303 | 158 (52.1) | −7.4 | −15.0 to 0.2 |
| RBZ (N=353) | 313 | 185 (59.1) | |||
*Inferential statistics were based on analysis of covariance model with the baseline BCVA as a covariate and region (country) and treatment as fixed factors.
†Inferential statistics were based on analysis of covariance model with the baseline CST as a covariate and region (country) and treatment as fixed factors.
‡Inferential statistics were based on analysis of covariance model with the baseline CRLT as a covariate and region (country) and treatment as fixed factors.
§Inferential statistics were based on analysis of covariance model with the baseline total CNV size as a covariate and region (country) and treatment group as fixed factors.
¶The adjusted difference and its 95% CI were analysed by a stratified Cochran-Mantel-Haenszel test with region (country) as a factor.
BCVA, best-corrected visual acuity (letter score); CNV, choroidal neovascularisation; CRLT, central retinal lesion thickness; CST, central subfield thickness; FAS, full analysis set; n, number of participants with available data at week 52; N, total number of participants; n’, number of participants with available assessment results at week 52 (percentages are based on n’); RBZ, reference ranibizumab.