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. Author manuscript; available in PMC: 2020 Feb 1.
Published in final edited form as: Ophthalmology. 2018 Sep 27;126(2):283–295. doi: 10.1016/j.ophtha.2018.08.021

table 3.

Proportion of baseline retinal thickness at each visit by treatment group. Values less than one indicate a decrease in retinal thickness with lower values indicating greater decreases.

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.