Table 1.
Baseline demographic and disease characteristics (all randomized patients)
| Variable (N) | Combination therapy (ranibizumab + laser) (N = 85) | Laser monotherapy (+ sham injection) (N = 43) |
|---|---|---|
| Mean age ± SD, years | 63.5 ± 9.3 | 63.5 ± 10.5 |
| Sex, n (%) | ||
| Male | 53 (62.4) | 27 (62.8) |
| Female | 32 (37.6) | 16 (37.2) |
| HbA1c | ||
| Mean SD ± SD | 7.5 ± 1.0 | 7.5 ± 1.2 |
| Median (range) | 7.2 (5.6–10.0) | 7.3 (5.8–9.6) |
| DME type, n (%) | ||
| Focal | 13 (15.3) | 6 (14.3) |
| Intermediate | 33 (38.8) | 18 (42.9) |
| Diffuse | 36 (42.4) | 18 (42.9) |
| Confounding factors† | 1 (1.2) | 0 (0.0) |
| Cannot grade | 2 (2.4) | 0 (0.0) |
| Missing | 0 (0.0) | 1 (2.3) |
| Time since first diagnosis of DME, median (range), years | 1.0 (0.0–8.8) | 1.3 (0.0–20.6) |
| Patients with PDR*, n (%) | 19 (22.4) | 7 (16.3) |
| Time since first PDR diagnosis, median (range), years | 1.4 (0.0–9.8) | 2.5 (0.0–14.7) |
| Mean VA at baseline (BCVA letter score), mean ± SD | 62.0 ± 11.7 | 64.6 ± 9.7 |
| Previous treatment | ||
| Laser (any specifications), n (%) | 62 (72.9) | 27 (62.8) |
DME = diabetic macular oedema, HbA1c = glycosylated haemoglobin, PDR = proliferative diabetic retinopathy, SD = standard deviation, VA = visual acuity. *Assessed by local study centres in 26 patients, one patient with missing data. †≥50% of leakage associated with neovascularization or other confounding factors.