Table 8.
Change in Visual Acuity (Last Observation Carried Forward) from Baseline to 1 Year* among Baseline Subgroups
| Baseline Subgroup | Sham + Prompt Laser, Ranib + Prompt Laser, Ranib + Deferred Laser, Triam + Prompt Laser, N | Change in Visual Acuity Mean ± SD |
≥10 Letter Improvement |
≥10 Letter Worsening |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sham + Prompt Laser | Ranib + Prompt Laser | Ranib + Deferred Laser | Triam + Prompt Laser | Sham + Prompt Laser | Ranib + Prompt Laser | Ranib + Deferred Laser | Triam + Prompt Laser | Sham + Prompt Laser | Ranib + Prompt Laser | Ranib + Deferred Laser | Triam + Prompt Laser | ||
| Pseudophakic at baseline | |||||||||||||
| No | 192, 131, 134, 124 | +2±13 | +9±10 | +10±14 | +2±14 | 27% | 54% | 54% | 26% | 15% | 2% | 3% | 20% |
| Yes | 101, 56, 54, 62 | +4±14 | +8±12 | +7±9 | +8±9 | 30% | 43% | 30% | 47% | 10% | 5% | 4% | 3% |
| Prior treatment for DME | |||||||||||||
| No | 105, 74, 74, 61 | +2±14 | +9±12 | +11±13 | +3±13 | 26% | 55% | 54% | 28% | 16% | 4% | 1% | 21% |
| Yes | 188, 113, 114, 125 | +3±13 | +9±10 | +8±12 | +5±13 | 29% | 48% | 42% | 35% | 12% | 3% | 4% | 11% |
| VA letter score (approximate Snellen equivalent) | |||||||||||||
| ≥66 (>20/50) | 146, 95, 95, 93 | +1±12 | +6±10 | +5±13 | +1±11 | 16% | 38% | 32% | 18% | 14% | 4% | 5% | 18% |
| ≤65 (≤20/50) | 147, 92, 93, 93 | +5±14 | +12±11 | +13±10 | +7±14 | 39% | 64% | 62% | 47% | 13% | 2% | 1% | 11% |
| OCT central subfield thickness | |||||||||||||
| <400 μm | 142, 111, 105, 114 | +3±11 | +7±11 | +7±12 | +3±12 | 23% | 43% | 41% | 25% | 13% | 4% | 4% | 14% |
| ≥400 μm | 151, 76, 82, 72 | +3±15 | +11±10 | +11±13 | +6±14 | 32% | 62% | 54% | 44% | 14% | 3% | 2% | 15% |
| Diabetic retinopathy severity | |||||||||||||
| Moderately severe NPDR or better | 178, 109, 113, 99 | 3±13 | 10±11 | 9±12 | 3±14 | 26% | 50% | 46% | 32% | 12% | 2% | 3% | 17% |
| Severe NPDR or worse | 100, 74, 64, 81 | 2±15 | 8±10 | 9±13 | 5±12 | 29% | 51% | 47% | 33% | 16% | 5% | 2% | 12% |
| Diffuse vs. focal edema as characterized by investigator† | |||||||||||||
| Typical/predominantly focal | 78, 60, 68, 53 | +3±13 | +8±11 | +8±13 | +3±11 | 27% | 53% | 43% | 26% | 10% | 2% | 4% | 15% |
| Neither predominantly focal nor diffuse | 71, 46, 41, 48 | +2±14 | +10±9 | +8±15 | +3±13 | 23% | 48% | 56% | 25% | 15% | 0 | 2% | 17% |
| Typical/predominantly diffuse | 144, 81, 79, 85 | +3±13 | +9±12 | +10±10 | +5±14 | 31% | 51% | 46% | 41% | 14% | 6% | 3% | 13% |
DME = diabetic macular edema; NPDR = non-proliferative diabetic retinopathy; OCT = optical coherence tomography; Ranib = ranibizumab; SD = standard deviation; Triam = triamcinolone; VA = visual acuity.
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.
Question asked: If diabetic macular edema is present, indicate how you would characterize its type, focal vs. diffuse, in your own daily practice. You are free to use, or not use, OCT, fluorescein angiography, or fundus photographs in addition to your clinical examination.