Patient demographics and baseline characteristics
| Safety population | Total (N=196)* | Treatment-naïve subgroup (N=55) |
| Mean age (SD), years | 67.5 (9.3) | 69.5 (10.3) |
| <65, n (%) | 69 (35.2) | 14 (25.5) |
| ≥65, n (%) | 127 (64.8) | 41 (74.5) |
| Sex, n (%) | ||
| Male | 121 (61.7) | 33 (60.0) |
| Female | 75 (38.3) | 22 (40.0) |
| Race, n (%) | ||
| Caucasian | 156 (79.6) | 42 (76.4) |
| Asian | 15 (7.7) | 3 (5.5) |
| Middle Eastern | 6 (3.1) | 3 (5.5) |
| Pacific Islander | 3 (1.5) | 1 (1.8) |
| Aboriginal | 4 (2.0) | 0 |
| African | 2 (1.0) | 0 |
| Maori | 1 (0.5) | 0 |
| Other | 9 (4.6) | 6 (10.9) |
| Mean DME duration (SD), years | 3.7 (3.6) | 2.9 (4.6) |
| Lens status, n (%) | ||
| Pseudophakic | 142 (72.4) | 40 (72.7) |
| Phakic | 54 (27.6) | 15 (27.3) |
| Study eye, n (%) | ||
| Right | 98 (50.0) | 24 (43.6) |
| Left | 98 (50.0) | 31 (56.4) |
| Mean IOP (SD), mm Hg | 14.6 (3.7) | 14.0 (3.7) |
| History of glaucoma, n (%) | ||
| Yes | 14 (7.1) | 7 (12.7) |
| No | 182 (92.9) | 48 (87.3) |
| Mean BCVA (SD), letters† | 57.3 (19.0) | 55.8 (18.7) |
| Range | 2, 96 | 10, 88 |
| Mean CRT (SD), µm† | 418.0 (119.4) | 418.6 (106.3) |
| Range | 76, 965 | 248, 702 |
| Central foveal-threatening lipid deposition, n (%)‡ | 72 (36.7) | 21 (38.2) |
*Included the treatment-naïve and non-responder subgroups.
†Efficacy population.
‡Based on the presence of hard exudates and central foveal involvement.
BCVA, best-corrected visual acuity; CRT, central retinal thickness; DME, diabetic macular oedema; IOP, intraocular pressure.