Table 3.
A Comparison of Retinal Thickening in the Two Treatment Groups at 3.5, 8, and 12 Months
| OCT Measurement in all eyes | |||||
|---|---|---|---|---|---|
| mETDRS Group | MMG Group | P-Value* | |||
| N | mean ± SD | N | mean ± SD | ||
| Central Subfield Thickness† | |||||
| Baseline | 121 | 371 ± 128 | 128 | 374 ± 113 | -- |
| 3.5 months | 114 | 323 ± 90 | 118 | 355 ± 129 | 0.04 |
| 8 months | 105 | 310 ± 98 | 113 | 339 ± 121 | 0.11 |
| 12 months‡ | 106 | 290 ± 81 | 107 | 324 ± 134 | 0.02 |
| Weighted Inner Zone Thickness | |||||
| Baseline | 151 | 341 ± 80 | 153 | 350 ± 76 | -- |
| 3.5 months | 133 | 320 ± 56 | 138 | 339 ± 80 | 0.03 |
| 8 months | 125 | 306 ± 48 | 131 | 327 ± 69 | 0.01 |
| 12 months‡ | 123 | 302 ± 50 | 127 | 317 ± 74 | 0.04 |
| Maximum Retinal Thickening§ | |||||
| Baseline | 160 | 148 ± 122 | 157 | 163 ± 111 | -- |
| 3.5 months | 147 | 116 ± 90 | 145 | 144 ± 121 | 0.08 |
| 8 months | 139 | 100 ± 89 | 139 | 131 ± 117 | 0.08 |
| 12 months‡ | 139 | 87 ± 78 | 134 | 120 ± 126 | 0.01 |
| Retinal Volume | |||||
| Baseline | 136 | 8.5 ± 1.6 | 121 | 8.7 ± 1.5 | -- |
| 3.5 months | 106 | 8.0 ± 1.2 | 95 | 8.5 ± 1.6 | 0.01 |
| 8 months | 105 | 7.9 ± 1.1 | 90 | 8.1 ± 1.4 | 0.19 |
| 12 months‡ | 107 | 7.7 ± 1.0 | 91 | 8.1 ± 1.5 | 0.03 |
*
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
†
Central subfield thickness-includes only eyes with central subfield thickness ≥ 250 microns at baseline
‡
P-values for log transformed 12-month data: Central subfield thickness P=0.05, weighted inner zone thickness P=0.06, maximum retinal thickening P=0.46 and retinal volume P=0.04
§
Maximum of central and 4 inner subfields