Table 1.
Patient Demographics and Baseline Characteristics
| Characteristic | THR-687 Dose Level |
Overall (n = 12) | ||
|---|---|---|---|---|
| Low (n = 3) | Middle (n = 3) | High (n = 6) | ||
| Age (yrs) | ||||
| Mean (SD) | 58.0 (9.54) | 59.7 (8.08) | 56.8 (13.14) | 57.8 (10.41) |
| Minimum–maximum | 47–64 | 51–67 | 38–72 | 38–72 |
| Male, no. (%) | 2 | 2 | 5 | 9 (75.0) |
| White race, no. (%) | 2 | 2 | 5 | 9 (75.0) |
| HbA1c (%) | ||||
| Mean (SD) | 6.87 (0.709) | 8.47 (1.815) | 8.93 (2.399) | 8.30 (2.023) |
| Minimum–maximum | 6.1–7.5 | 6.4–9.8 | 6.8–12.5 | 6.1–12.5 |
| Diabetic retinopathy scale, no. (%) | ||||
| Moderate NPDR | 1 | 2 | 6 | 9 (75.0) |
| Severe NPDR | 1 | 0 | 0 | 1 (8.3) |
| PDR | 1 | 1 | 0 | 2 (16.7) |
| BCVA (ETDRS letters) | ||||
| Mean (SD) | 59.3 (2.08) | 54.7 (2.31) | 55.7 (8.26) | 56.3 (6.02) |
| Minimum–maximum | 57–61 | 52–56 | 39–61 | 39–61 |
| CST (μm) | ||||
| Mean (SD) | 557.7 (123.50) | 538.3 (41.30) | 429.5 (78.11) | 488.8 (98.68) |
| Minimum–maximum | 434–681 | 491, 567 | 330, 524 | 330, 681 |
| Prior treatment for DME, no. (%)∗ | ||||
| Anti-VEGF | 3 | 3 | 6 | 12 (100.0) |
| Corticosteroids | 1 | 0 | 1 | 2 (16.7) |
BCVA = best-corrected visual acuity; CST = central subfield thickness; DME = diabetic macular edema; ETDRS = Early Treatment Diabetic Retinopathy Study; HbA1c = glycated hemoglobin A; NPDR = nonproliferative diabetic retinopathy; PDR = proliferative diabetic retinopathy; SD = standard deviation; VEGF = vascular endothelial growth factor.
∗
All subjects received prior anti-VEGF and/or corticosteroids treatment, per study inclusion criteria.