Table 9.
Change in Retinal Thickness from Baseline to 56-Week Visit*
| Change in OCT Central Subfield Thickness | Sham+ Focal/Grid/PRP Laser | Ranibizumab+ Focal/Grid/PRP Laser | Triamcinolone+ Focal/Grid/PRP Laser |
|---|---|---|---|
|
| |||
| N = 101 | N = 92 | N = 89 | |
| Overall Change† | |||
| Thickness(μm) Median (25th, 75th percentile) | 282 (225, 352) | 297 (239, 390) | 288 (248, 400) |
| Change from baseline (μm) Mean±standard deviation | −71±156 | −52±227 | −40±138 |
| Change from baseline (μm) Median (25th, 75th percentile) | −45 (−179, +33) | −53 (−150, +20) | −34 (−128, +41) |
| Difference in mean change from sham+focal/grid/PRP laser (95% CI) [P Value] ‡ | +22 (−22, +66) [P = 0.25] |
+15 (−30, +60) [P = 0.45] |
|
| Thickness ≥10% increase with at least a 25 μm increase from baseline, no. (%) | 28 (28%) | 18 (20%) | 25 (28%) |
| Relative risk (95% CI) [P Value] ‡ for comparison with sham+focal/grid/PRP laser | 1.0 | 0.74 (0.42, 1.31) [P = 0.24] |
0.97 (0.58, 1.62) [P = 0.91] |
| Thickness <250 with at least a 25 μm decrease from baseline, no. (%) | 27 (27%) | 27 (29%) | 18 (20%) |
| Relative risk (95% CI) [P Value] ‡ for comparison with sham+focal/grid/PRP laser | 1.0 | 1.13 (0.68, 1.87) [P = 0.60] |
0.76 (0.42, 1.36) [P = 0.29] |
| LogOCT, no (%) || | |||
| Two or more step improvement | 30 (30%) | 19 (21%) | 15 (17%) |
| At least 1, but less than 2 step improvement | 15 (15%) | 25 (27%) | 19 (21%) |
| Less than 1 step improvement and less than 1 step worsening | 42 (42%) | 34 (37%) | 41 (46%) |
| At least 1 step but less than 2step worsening | 9 (9%) | 7 (8%) | 9 (10%) |
| Two or more step worsening | 5 (5%) | 7 (8%) | 5 (6%) |
Visits occurring between 315 and 468 days (between 45 and 67 weeks) from randomization were included as 56-week visits. When more than 1 visit occurred in this window, data from the visit closest to the 56-week target date were used.
Missing (or ungradeable) data as follows for the sham+focal/grid/PRP laser group, ranibizumab+focal/grid/PRP laser group, and triamcinolone+focal/grid/PRP laser group, and respectively: 10, 3, 4.
Adjusted for baseline optical coherence tomography (OCT) retinal thickness and visual acuity, number of planned panretinal photocoagulation (PRP) sittings, and correlation between 2 study eyes. Confidence intervals (CI) are adjusted for multiple comparisons.
Logarithmic transformation of OCT central subfield thickness (LogOCT) is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values.