table 3.
Proportion of Baseline within Each Treatment Group* | ||||||
Estimate (99.87%Confidence interval)† P-value | ||||||
Periocular | Intravitreal | Dexamethasone | ||||
Week 4 | 0.78 (0.69, 0.89) | <0.0001 | 0.58 (0.50, 0.66) | <0.0001 | 0.56 (0.48, 0.65) | <0.0001 |
Week 8 | 0.77 (0.67, 0.89) | <0.0001 | 0.61 (0.53, 0.70) | <0.0001 | 0.54 (0.46, 0.63) | <0.0001 |
Week 12 | 0.75 (0.64, 0.86) | <0.0001 | 0.61 (0.54, 0.69) | <0.0001 | 0.63 (0.53, 0.75) | <0.0001 |
Week 24 | 0.68 (0.59, 0.79) | <0.0001 | 0.64 (0.56, 0.74) | <0.0001 | 0.61 (0.52, 0.71) | <0.0001 |
Ratio of the Proportion of Baseline between Treatment Groups | ||||||
Estimate (99.87%Confidence interval)† P-value | ||||||
Superiority Hypotheses | Non-inferiority Hypothesis‡ | |||||
Intravitreal/ Periocular |
Dexamethasone/ Periocular |
Dexamethasone/ Intravitreal |
||||
Week 4 | 0.73 (0.61, 0.88) | <0.0001 | 0.71 (0.59, 0.86) | <0.0001 | 0.97 (0.80, 1.18) | n/a |
Week 8 | 0.79 (0.65, 0.96) | <0.0001 | 0.69 (0.56, 0.86) | <0.0001 | 0.88 (0.71, 1.08) | n/a |
Week 12 | 0.82 (0.67, 0.98) | 0.0003 | 0.84 (0.67, 1.06) | 0.012 | 1.03 (0.84, 1.27) | n/a |
Week 24 | 0.95 (0.77, 1.16) | 0.35 | 0.89 (0.72, 1.10) | 0.07 | 0.94 (0.77, 1.16) | n/a |
The percent decline from baseline is 100*(1-proportion of baseline). For example, there is a 23% decrease for periocular, a 39% decrease for intravitreal, and a 46% decrease for dexamethasone at week 8.
The two-sided type I error threshold was 0.00132 since recruitment was halted after the single pre-planned interim analysis.
Non-inferiority is evaluated by comparing the upper limit of the 99.87% confidence interval with the pre-defined non-inferiority margin as opposed to p-values, which translates to a one-sided test with a type I error rate of 0.00066. The non-inferiority margin for the comparison between dexamethasone and intravitreal treatment was 1.16, i.e. dexamethasone is considered non-inferior if the upper boundary of the 99.87% confidence interval is less than 1.16.