Table 4.
Changes in Retinal Thickening from Baseline to 12 Months in the Two Treatment Groups Stratified by Degree of Thickening at Baseline
mETDRS Group | MMG Group | |||
---|---|---|---|---|
N | mean ± SD | N | mean ± SD | |
Change in Central Subfield Thickening at 12 Months* | ||||
Total | 106 | −88 ± 138 | 107 | −49 ± 122 |
Baseline Central Subfield Thickness* | ||||
250–349 microns | 62 | −22 ± 62 | 53 | −7 ± 79 |
350–449 microns | 22 | −75 ± 84 | 32 | −74 ± 100 |
≥ 450 microns | 22 | −285 ± 155 | 22 | −112 ± 189 |
P-value for interaction† | <0.001‡ / 0.04§ | |||
Change in Weighted Inner Zone Thickening at 12 Months | ||||
Total | 123 | −42 ± 83 | 127 | −28 ± 67 |
Baseline Weighted Inner Zone Thickness | ||||
250–349 microns | 88 | −14 ± 42 | 81 | −12 ± 52 |
350–449 microns | 22 | −55 ± 60 | 36 | −49 ± 56 |
≥ 450 microns | 13 | −208 ± 120 | 9 | −92 ± 146 |
P-value for interaction† | <0.001‡ / 0.04§ | |||
Change in Maximum Retinal Thickening at 12 Months|| | ||||
Total | 139 | −66 ± 123 | 134 | −39 ± 114 |
Baseline Maximum Retinal Thickening | ||||
0 – 99 microns | 63 | −4 ± 53 | 49 | +17 ± 86 |
100 – 199 microns | 38 | −51 ± 65 | 43 | −55 ± 73 |
≥ 200 microns | 38 | −184 ± 162 | 42 | −89 ± 147 |
P-value for interaction† | <0.001‡ / 0.24§ | |||
Change in Retinal Volume at 12 Months | ||||
Total | 107 | −0.8 ± 1.4 | 91 | −0.4 ± 1.3 |
Baseline Retinal Volume | ||||
< 8 mm3 | 54 | −0.2 ± 0.5 | 33 | −0.4 ± 0.4 |
8 – < 9 mm3 | 29 | −0.6 ± 0.8 | 29 | 0.2 ± 1.5 |
≥ 9 mm3 | 24 | −2.3 ± 2.1 | 29 | −1.1 ± 1.4 |
P-value for interaction† | 0.03‡ / 0.38§ |
Central subfield thickening includes only eyes with central subfield thickness = 250 microns at baseline
Statistical test for whether treatment group difference varies according to baseline OCT measurement. P-value obtained using repeated measures least squares regression models adjusting for baseline values and accounting for the correlated data from subjects with 2 study eyes.
P-value based on the absolute change from baseline to follow up
P-value based on the log of the ratio of follow up to baseline
Maximum of central and 4 inner subfields
Note one eye in the MMG group had baseline Weighted Inner Zone thickness < 250 microns