Table 7.
Change in Retinal Thickness from Baseline to Three Year Study Visit*
| Ranibizumab + Prompt Laser treatment N = 136 | Ranibizumab + Deferred Laser treatment N = 132 | |
|---|---|---|
| OCT Central Subfield Thickness | ||
|
| ||
| Thickness (μm) at 3-year visit | ||
| Mean ± SD | 249 ± 103 | 238 ± 65 |
| Median (25th, 75th percentile) | 224 (192, 268) | 229 (192, 274) |
| Change from baseline (μm)† | ||
| Mean ± SD | −152 ± 165 | −174 ± 139 |
| Median (25th, 75th percentile) | −142 (−249, −55) | −155 (−248, −66) |
| Difference in mean change from ranibizumab + prompt laser treatment (95% CI) [P value]§ | --- | −1 (−20, +19) [P = 0.94] |
| Thickness <250 with at least a 25 μm decrease from baseline, no. (%) | 80 (61%) | 80 (63%) |
| Relative risk (95% CI) [P value]§ | --- | 1.02 (0.84, 1.24) P = 0.82 |
|
| ||
| OCT Retinal Volume | ||
|
| ||
| Total volume (mm3) at 3-year visit | ||
| Mean ± SD | 7.2 ± 1.4 | 7.0 ± 0.9 |
| Median (25th, 75th percentile) | 6.9 (6.4, 7.5) | 6.9 (6.5, 7.5) |
| Change from baseline (mm3)‡ | ||
| Mean±SD | −1.6 ± 1.6 | −1.8 ± 1.9 |
| Median (25th, 75th percentile) | −1.2 (−2.6, −0.6) | −1.3 (−2.1, −0.5) |
| Difference in mean change from ranibizumab + prompt laser treatment(95% CI) [P value]§ | --- | −0.09 (−0.37, +0.20) P = 0.56 |
OCT = optical coherence tomography; SD = standard deviation; CI = confidence interval.
Includes only eyes with OCT measurements at baseline and 3-year study visits, visits occurring between 980 and 1204 days (between 140 and 172 weeks) from randomization were included as 3-year visits. When more than one visit occurred in this window, data from the visit closest to the 3-year target date were used.
Missing (or ungradable) data as follows for the ranibizumab + prompt laser treatment and ranibizumab + deferred laser treatment, respectively: 5 and 4.
Based on longitudinal analysis, adjusted for baseline visual acuity and baseline CSF for OCT CSF change and baseline visual acuity and baseline volume for OCT volume change.
For comparison with ranibizumab + prompt laser treatment
Missing (or ungradable) data as follows for the ranibizumab + prompt laser treatment and ranibizumab + deferred laser treatment, respectively: 52 and 40.