Table 5.
Change in Visual Acuity (Last Observation Carried Forward) from Baseline to 1 Year (Primary Outcome)*
| Sham + Prompt Laser N=293 | Ranibizumab + Prompt Laser N=187 | Ranibizumab + Deferred Laser N=188 | Triamcinolone + Prompt Laser N=186 | |
|---|---|---|---|---|
| Change in visual acuity (letters) | ||||
| Mean ± SD | +3±13 | +9±11 | +9±12 | +4±13 |
| Median (25th, 75th percentile) | +5 (−2, +10) | +10 (+3, +16) | +9 (+5, +15) | +5 (−3, +12) |
| Difference in mean change from sham + prompt laser (95% CI) [P value]† | +5.8 (+3.2 to +8.5) [P <0.001] | +6.0 (+3.4 to +8.6) [P<0.001] | +1.1 (−1.5 to +3.7) [P=0.31] | |
| Distribution of change, No. (%) | ||||
| ≥15 letter improvement | 43 (15%) | 57 (30%) | 52 (28%) | 39 (21%) |
| 14–10 letter improvement | 38 (13%) | 38 (20%) | 36 (19%) | 22 (12%) |
| 9–5 letter improvement | 67 (23%) | 34 (18%) | 54 (29%) | 32 (17%) |
| Same ± 4 letters | 86 (29%) | 38 (20%) | 35 (19%) | 54 (29%) |
| 5–9 letters worse | 20 (7%) | 14 (7%) | 5 (3%) | 12 (6%) |
| 10–14 letters worse | 16 (5%) | 3 (2%) | 2 (1%) | 12 (6%) |
| ≥15 letters worse | 23 (8%) | 3 (2%) | 4 (2%) | 15 (8%) |
| Difference in proportion with ≥10 letter improvement from sham + prompt laser (95% CI)‡ | +23% (+13% to +34%) | +19% (+9% to +29%) | +6% (−4% to +16%) | |
| Relative risk (95% CI) [P value]§ for comparison with sham + prompt laser | 1.0 | 1.84 (1.40 to 2.42) [P<0.001] | 1.68 (1.27 to 2.21) [P<0.001] | 1.21 (0.88 to 1.66) [P=0.16] |
| Difference in proportion with ≥10 letter worsening from sham + prompt laser (95% CI)‡ | −10% (−16% to −5%) | −10% (−16% to −4%) | +1% (−7% to +9%) | |
| Relative risk (95% CI) [P value]‡ for comparison with sham + prompt laser | 1.0 | 0.24 (0.09 to 0.65) [P<0.001] | 0.24 (0.08 to 0.68) [P=0.001] | 1.08 (0.62 to 1.87) [P=0.75] |
| Difference in proportion with ≥15 letter improvement from sham + prompt laser (95% CI)‡ | +16% (+6% to +26%) | +13% (+4% to +22%) | +6% (−2% to +15%) | |
| Relative risk (95% CI) [P value]§ for comparison with sham + prompt laser | 1.0 | 2.09 (1.35 to 3.22) [P<0.001] | 1.89 (1.25 to 2.87) [P<0.001] | 1.43 (0.90 to 2.29) [P=0.07] |
| Difference in proportion with ≥15 letter worsening from sham + prompt laser (95% CI)‡ | −6% (−11% to −2%) | −6% (−10% to −1%) | 0 (−6% to +6%) | |
| Relative risk (95% CI) [P value]§ for comparison with sham + prompt laser | 1.0 | 0.21 (0.05 to 0.87) [P=0.009] | 0.28 (0.08 to 0.97) [P=0.01] | 1.02 (0.47 to 2.20) [P=0.95] |
CI = confidence interval; SD = standard deviation.
Visits occurring between 308 and 420 days (between 44 and 60 wks) from randomization were included as 1-yr visits. When > 1 visit occurred in this window, data from the visit closest to the 1-yr target date were used. For other eyes without any 1-yr data (19 eyes in the sham + prompt laser group, 16 eyes in the ranibizumab + prompt laser group, 10 eyes in the ranibizumab + deferred laser group, and 10 eyes in the triamcinolone + prompt laser group), the last observation carried forward method was used to impute data for the primary analysis.
Analysis of covariance adjusted for baseline visual acuity and correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons.
Adjusted for correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons.
Logistic regression adjusted for correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons.