Table 6.
Secondary Outcomes at 16-Week Visit
| Overall | Did not Develop Central-Involved Macular Edema |
Developed Central-Involved Macular Edema |
|
|---|---|---|---|
| Visual Acuity | N = 279 | N = 246 * | N = 30 * |
| Baseline visual acuity- E-ETDRS Letter score Mean±STD (Median) |
66±15 (69) | 67±15 (70) | 60±15 (63) |
| Baseline visual acuity- Snellen Equivalent Mean |
20/50 | 20/50 | 20/63 |
| Proportion Letter score ≥69 (20/40) at baseline – N (%) |
144 (52%) | 134 (54%) | 10 (33%) |
| 16-week Outcomes | |||
| VA- Mean±STD (Median) | 78±12 (81) | 80±11 (82) | 69 ± 12 (72) |
| Snellen Equivalent – Mean (Median) | 20/32 (20/25) | 20/25 (20/25) | 20/40 (20/40) |
| E-ETDRS Letters Change at 16-week- Mean ± STD (Median) |
+12±14 (+10) | +13 ±14 (+11) | + 9±14 (+5) |
| Distribution at 16-week - N (%) | |||
| Proportion letter score ≥69 (20/40) | 241 (86%) | 219 (89%) | 20 (67%) |
| Proportion with ≥10 Letter Gain | 148 (53%) | 135 (55%) | 11 (37%) |
| Proportion with ≥20 Letter Gain | 66 (24%) | 58 (24%) | 6 (20%) |
| Proportion with ≥10 Letter Loss | 11 (4%) | 7 (3%) | 3 (10%) |
| Proportion with ≥20 Letter Loss | 1 (<1%) | 0 (0%) | 0 (0%) |
| OCT From Time Domain Machine ¶ | N=261 | N=233 | N=28 |
| Baseline CSF μm-Median (25th , 75th Percentile) |
202 (182, 220) | 201 (181, 218) | 204 (191, 235) |
| CSF Thickness (μm) at 16 weeks-Median (25th, 75th Percentile) |
210 (192, 237) | 208 (190, 231) | 297 (254, 357) |
| CSF Thickness (μm) at 16 weeks (if DME treatment was given, last value before treatment carried to 16 weeks)- Median (25th, 75th Percentile) |
212 (193, 241) | 208 (190, 231) | 309 (283,422) |
| CSF Thickness Change (μm) from Baseline at 16 weeks - Median (25th , 75th Percentile) |
+9 (+1, +27) | +8 (0, +19) | +89 (+63, +133) |
| CSF Thickness Change (μm) from Baseline (16 weeks value obtained from last observation before DME treatment given) Median (25th , 75th Percentile) |
+10 (+1, +28) | +8 (0, +19) | +104 (+81, +196) |
| Relative CSF Thickness Change from Baseline- % Median (25th, 75th Percentile) |
+5% (0%, +14%) | +4% (0%, +9%) | +41% (+30%, +67%) |
| Proportion with CSF Thickness >250 and increased at least 25μm- N (%) |
35 (13%) | 13 (6%) | 22 (79%)¦ |
| Total Volume mm3- Median (25th, 75th percentile)† |
7.0 (6.5, 7.5) | 6.9 (6.5, 7.4) | 7.8 (7.2,8.6) |
| Total Volume mm3 change from baseline- Median (25th, 75th percentile) ∥ |
+0.3 (+0.1, +0.6) | +0.2 (+0.1, +0.5) | +1.2 (+0.4, +1.6) |
|
Diabetic Retinopathy Progression From Baseline§ – N (%) |
|||
| ≥2 Step Worsening | 2 (1%) | 1 (<1%) | 1 (3%) |
| 1 Step Worsening | 25 (9%) | 22 (9%) | 3 (10%) |
| No Change | 229 (82%) | 202 (82%) | 24 (80%) |
| 1 Step Improvement | 25 (9%) | 22 (9%) | 3 (10%) |
| ≥2 Step Improvement | 2 (1%) | 1 (<1%) | 1 (3%) |
E-ETDRS= Electronic early treatment diabetic retinopathy study; STD=standard deviation; OCT=optical coherence tomography; CSF=central subfield; DME=diabetic macular edema;
Outcome could not be calculated for 3 eyes with non-gradable or missing OCT at baseline or 16-week visit.
Seven eyes that had baseline and 16-week OCT obtained by different time and spectral domain machines were excluded.
For eyes receiving DME treatment, last CSF thickness before treatment is used.
Missing in 8, 5, and 3 for the overall, did not, and did develop central involved macular edema cohorts respectively.
Missing in 25, 19, and 6 for the overall, did not, and did develop central involved macular edema cohorts respectively
By clinical exam. Scale: none, microaneurysms only, mild/moderate non- proliferative diabetic retinopathy, severe non- proliferative diabetic retinopathy and proliferative diabetic retinopathy.