Key patient demographics and baseline diabetes and ocular characteristics (randomised set)
| T&E ranibizumab 0.5 mg+laser n=121 | T&E ranibizumab 0.5 mg n=128 | PRN ranibizumab 0.5 mg n=123 | |
|---|---|---|---|
| Characteristic | |||
| Mean age±SD, years | 63.7±9.1 | 63.0±9.8 | 64.5±9.7 |
| Gender, n (%) | |||
| Male | 78 (64.5) | 77 (60.2) | 77 (62.6) |
| Female | 43 (35.5) | 51 (39.8) | 46 (37.4) |
| Race, n (%) | |||
| Caucasian | 114 (94.2) | 126 (98.4) | 117 (95.1) |
| Black | 3 (2.5) | 1 (0.8) | 3 (2.4) |
| Asian | 1 (0.8) | 0 (0.0) | 1 (0.8) |
| Other | 3 (2.5) | 1 (0.8) | 2 (1.6) |
| Mean HbA1c±SD, % | 7.8±1.4 | 7.9±1.3 | 8.0±1.2 |
| Diabetes, n (%) | |||
| Type I | 10 (8.3) | 12 (9.4) | 10 (8.1) |
| Type II | 111 (91.7) | 116 (90.6) | 113 (91.9) |
| DMO, n (%) | |||
| Focal | 36 (29.8) | 28 (22.0) | 32 (26.0) |
| Diffuse | 62 (51.2) | 72 (56.7) | 70 (56.9) |
| Mean time since DMO diagnosis (±SD), years | 2.54±3.2 | 2.64±3.1 | 2.53±3.0 |
| Time since first diagnosis of DMO (categorised), months, n (%) | |||
| ≤3 | 16 (13.2) | 15 (11.8) | 18 (14.6) |
| >3–<12 | 32 (26.4) | 32 (25.2) | 28 (22.8) |
| ≥12 | 70 (57.9) | 79 (62.2) | 77 (62.6) |
| Mean CSFT±SD, μm | 480.7±165.0 | 452.4±131.2 | 432.5±129.9 |
| Mean BCVA±SD (letters) | 61.7±12.2 | 63.9±10.8 | 64.7±10.2 |
| Range (BCVA ETDRS letters) | 23–80 | 34–83 | 39–84 |
Randomised set included all randomised patients (ie, those assigned a randomisation number).
BCVA, best-corrected visual acuity; CSFT, central subfield thickness; DMO, diabetic macular oedema; ETDRS, Early Treatment Diabetic Retinopathy Study; HbA1c, glycosylated haemoglobin; PRN, pro re nata; T&E, treat-and-extend.