Table 12.
Change in Retinal Thickening from Baseline to 2 Years*
| Change in OCT Central Subfield Thickness† | Sham + Prompt Laser N = 152 | Ranibizumab + Prompt Laser N = 99 | Ranibizumab + Deferred Laser N = 100 | Triamcinolone + Prompt Laser N = 93 |
|---|---|---|---|---|
| Overall Change | ||||
| Thickness (microns) Median (25th, 75th percentile) | 267 (204, 350) | 240 (197, 289) | 231 (206, 288) | 258 (207, 330) |
| Change from baseline (microns) Mean±SD | −133±145 | −144±165 | −170±143 | −95±158 |
| Change from baseline (microns) Median (25th, 75th percentile) | −104 (−231, −25) | −107 (−255, −37) | −146 (−229, −81) | −78 (−176, −12) |
| Difference in mean change from sham+prompt laser (95% CI) [P value]‡ | −31 (−60, −0.9) [P = 0.01] | −36 (−66, −7) [P = 0.004] | −3 (−34, +28) [P = 0.81] | |
| Thickness <250 with at least a 25 micron decrease from baseline, no. (%) | 57 (38%) | 53 (54%) | 55 (55%) | 41 (44%) |
| Relative risk (95% CI) [P Value]§ for comparison with sham+prompt laser | 1.36 (1.01, 1.84) [P = 0.01] | 1.39 (1.01, 1.90) [P = 0.01] | 1.18 (0.85, 1.63) [P = 0.22] | |
| LogOCT, no. (%)∥ | ||||
| Two or more step improvement | 65 (43%) | 44 (44%) | 56 (56%) | 33 (35%) |
| Two or more step worsening | 2 (1%) | 1 (1%) | 0 | 4 (4%) |
CI = confidence interval; OCT = optical coherence tomography; SD = standard deviation.
Visits occurring between 616 and 840 days (between 88 and 120 weeks) from randomization were included as 2-year visits. When more than 1 visit occurred in this window, data from the visit closest to the 2-year target date were used.
Missing (or ungradeable) data as follows for the sham+prompt laser, ranibizumab+prompt laser, ranibizumab+deferred laser, and triamcinolone+prompt laser groups, respectively: 11, 7, 12, 10.
Analysis of covariance adjusted for baseline OCT retinal thickness and visual acuity and correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons.
Logistic regression adjusted for baseline OCT retinal thickness and visual acuity and correlation between 2 study eyes. Confidence intervals 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. (Ferris FL III, Miller KM, Glassman AR, Beck RW. A proposed method of logarithmic transformation of optical coherence tomography data for use in clinical research. Ophthalmology. In Press.)