Table 2. Ocular baseline characteristics by study arm.
| Fixed dosing | PRN dosing | |
|---|---|---|
| ETDRS BCVA, mean (SD) (N) | 57.5 (9.5) (50) | 61.2 (8.6) (50) |
| Duration of DME (months), median (IQR) (N) | 35.5 (15.0, 51.0) (50) | 37.0 (18.0, 48.0) (50) |
| Prior treatments | ||
| Macular laser therapy, n (%) (N) | 46 (92) (50) | 48 (96) (50) |
| Pan-retinal photocoagulation, n (%) (N) | 14 (28) (50) | 8 (16) (50) |
| Intravitreal anti-VEGF, n (%) (N) | 17 (34) (50) | 17 (34) (50) |
| Intravitreal steroids, n (%) (N) | 5 (10) (50) | 3 (6) (50) |
| OCT findings | ||
| CRT (μm), mean (SD) (N) | 479.8 (128.4) (50) | 466.7 (144.1) (50) |
| CST (μm), mean (SD) (N) | 472.4 (113.5) (50) | 467.9 (126.4) (50) |
| Macular volume (mm3), mean (SD) (N) | 10.0 (2.5) (50) | 10.4 (2.1) (50) |
| Lens status | ||
| Pseudophakic, n (%) (N) | 16 (32) (50) | 11 (22) (50) |
| Phakic, n (%) (N) | 34 (68) (50) | 39 (78) (50) |
| Presence of cataract, n (%) (N) | 24 (70.6) (34) | 31 (79.5) (39) |
| ETDRS grade of retinopathy | ||
| Mild NPDR, n (%) (N) | 16 (32) (50) | 17 (34) (50) |
| Moderate NPDR, n (%) (N) | 17 (34) (50) | 21 (42) (50) |
| Severe NPDR, n (%) (N) | 5 (10) (50) | 7 (14) (50) |
| Treated PDR, n (%) (N) | 11 (22) (50) | 5 (10) (50) |
| Not available, n (%) (N) | 1 (2) (50) | 0 (0) (50) |
| FFA findings | ||
| FAZ GLD (mm), mean (SD) (N) | 808.5 (271.8) (50) | 769.0 (190.4) (50) |
| FAZ Area (mm2), median (IQR) (N) | 0.5 (0.3, 0.7) (49) | 0.4 (0.3, 0.6) (50) |
Abbreviations: BCVA, best-corrected visual acuity; CRT, central retinal thickness; CST, central subfield thickness; DME, diabetic macular edema; ETDRS, Early Treatment Diabetic Retinopathy Study; FAZ, foveal avascular zone; FFA, Fundus fluorescein angiography; GLD, greatest linear dimension; IQR, interquartile range; n, number of patients; N, total number of patients; NPDR, non-proliferative diabetic retinopathy; PDR, proliferative diabetic retinopathy; PRN, pro-re-nata; VEGF, vascular endothelial growth factor.