Table 2.
Patient baseline demographics and disease characteristics (FAS)
| Characteristic | IVT-AFL fixed (N = 153) | IVT-AFL T&E (N = 152) | IVT-AFL PRN (N = 153) |
|---|---|---|---|
| Mean age, years (SD) | 64.4 (8.6) | 64.7 (10.1) | 65.5 (9.2) |
| Age range, years | |||
| 18–64 | 71 (46.4) | 69 (45.4) | 67 (43.8) |
| 65–84 | 82 (53.6) | 83 (54.6) | 84 (54.9) |
| ≥ 85 | 0 | 0 | 2 (1.3) |
| Sex | |||
| Male | 98 (64.1) | 94 (61.8) | 89 (58.2) |
| Race | |||
| White | 139 (90.8) | 142 (93.4) | 146 (95.4) |
| Black | 1 (0.7) | 0 | 0 |
| Asian | 2 (1.3) | 1 (0.7) | 0 |
| Not reported | 11 (7.2) | 9 (5.9) | 7 (4.6) |
| HbA1c | |||
| Mean (SD) | 7.7 (1.4) | 7.7 (1.3) | 7.8 (1.3) |
| > 8% | 55 (35.9) | 52 (34.2) | 51 (33.3) |
| ≤ 8% | 93 (60.8) | 96 (63.2) | 100 (65.4) |
| Prior participation in the AQUA study | |||
| Yes | 145 (94.8) | 144 (94.7) | 148 (96.7) |
| No | 8 (5.2) | 8 (5.3) | 5 (3.3) |
| Mean BVCA ETDRS letters (SD) | |||
| At start of IVT-AFL treatment | 62.2 (10.7) | 62.6 (10.8) | 60.5 (11.4) |
| At VIOLET study baseline | 72.7 (10.4) | 72.5 (11.4) | 71.0 (10.9) |
| Change from start of IVT-AFL treatment to VIOLET study baseline | 10.5 (7.6) | 10.0 (7.3) | 10.4 (9.7) |
| Mean CRT, µm (SD) | 289.9 (66.8) | 285.9 (76.3) | 294.6 (81.0) |
| DRSSa | |||
| DR absent (10) | 2 (1.3) | 0 | 0 |
| DR questionable (15) | 0 | 1 (0.7) | 0 |
| Microaneurysms only (20) | 1 (0.7) | 2 (1.3) | 0 |
| Mild NPDR (35) | 84 (54.9) | 94 (61.8) | 89 (58.2) |
| Moderate NPDR (43) | 47 (30.7) | 36 (23.7) | 44 (28.8) |
| Moderately severe NPDR (47) | 9 (5.9) | 10 (6.6) | 13 (8.5) |
| Severe NPDR (53) | 0 | 4 (2.6) | 4 (2.6) |
| Mild PDR (61) | 6 (3.9) | 2 (1.3) | 0 |
| High-risk PDR (71) | 0 | 0 | 1 (0.7) |
| Cannot grade (90) | 4 (2.6) | 3 (2.0) | 2 (1.3) |
Values are n (%) unless otherwise stated. Patients had previously received 1 year of IVT-AFL treatment prior to the VIOLET study baseline; data are for VIOLET study baseline unless otherwise stated
BVCA best-corrected visual acuity, CRT central retinal thickness, DR diabetic retinopathy, DRSS Diabetic Retinopathy Severity Score, ETDRS Early Treatment Diabetic Retinopathy Study, FAS full analysis set, HbA1c glycated hemoglobin, IVT-AFL intravitreal aflibercept, NPDR non-proliferative diabetic retinopathy, PDR proliferative diabetic retinopathy, PRN pro re nata, SD standard deviation, T&E treat-and-extend
aBased on 7-field fundus photography images