Baseline demographic and study eye characteristics of the ITT population
| Characteristic | DEX implant 0.7 mg | DEX implant 0.35 mg | Sham procedure |
|---|---|---|---|
| Demographic characteristics | |||
| Age, years | N=351 | N=347 | N=350 |
| Mean (SD) | 62.5 (8.3) | 62.3 (9.2) | 62.5 (9.5) |
| Range | 33–85 | 25–84 | 26–88 |
| Gender, n (%) | N=351 | N=347 | N=350 |
| Male | 213 (60.7) | 206 (59.4) | 217 (62.0) |
| Race/ethnicity, n (%) | N=351 | N=347 | N=350 |
| Asian | 55 (15.7) | 58 (16.7) | 54 (15.4) |
| Black | 16 (4.6) | 16 (4.6) | 20 (5.7) |
| Caucasian | 234 (66.7) | 234 (67.4) | 233 (66.6) |
| Hispanic | 35 (10.0) | 34 (9.8) | 33 (9.4) |
| Other | 11 (3.1) | 5 (1.4) | 10 (2.9) |
| Diabetes type, n (%) | N=351 | N=347 | N=350 |
| Type 1 | 34 (9.7) | 22 (6.3) | 28 (8.0) |
| Type 2 | 314 (89.5) | 325 (93.7) | 322 (92.0) |
| Not available | 3 (0.9) | 0 | 0 |
| Duration of diabetes, years | N=349 | N=347 | N=348 |
| Mean (SD) | 16.5 (9.0) | 15.8 (9.4) | 15.9 (9.1) |
| HbA1c, % | N=347 | N=345 | N=349 |
| Mean (SD) | 7.6 (1.2) | 7.5 (1.1) | 7.5 (1.1) |
| Study eye characteristics | |||
| ETDRS letter score | N=351 | N=347 | N=350 |
| Mean (SD) | 56.1 (9.9) | 55.5 (9.7) | 56.9 (8.7) |
| CSRT, µm | N=348 | N=344 | N=342 |
| Mean (SD) | 463.0 (157.1) | 466.8 (159.5) | 460.9 (132.6) |
| Study eyes with CSRT >250 µm, % | 94.5 | 94.8 | 95.9 |
| Duration of DME, months | N=350 | N=347 | N=349 |
| Mean (SD) | 23.6 (26.0) | 25.2 (31.4) | 25.9 (27.3) |
| Range | 0–163 | 0–299 | 0–187 |
| DME classification, n (%)* | N=351 | N=347 | N=350 |
| Focal | 127 (36.2) | 136 (39.2) | 142 (40.6) |
| Intermediate | 134 (38.2) | 124 (35.7) | 122 (34.9) |
| Diffuse | 69 (19.7) | 60 (17.3) | 72 (20.6) |
| Not available | 16 (4.6) | 25 (7.2) | 10 (2.9) |
| None | 5 (1.4) | 2 (0.6) | 4 (1.1) |
| Previous DME treatment, n (%) | N=351 | N=347 | N=350 |
| Focal/grid laser | 231 (65.8) | 224 (64.6) | 243 (69.4) |
| Intravitreal steroid | 58 (16.5) | 69 (19.9) | 61 (17.4) |
| Anti-VEGF | 25 (7.1) | 39 (11.2) | 26 (7.4) |
| None | 104 (29.6) | 98 (28.2) | 89 (25.4) |
| Severity of NPDR, n (%) | N=351 | N=347 | N=350 |
| Moderate or better | 173 (49.3) | 170 (49.0) | 174 (49.7) |
| Severe or worse | 151 (43.0) | 151 (43.5) | 149 (42.6) |
| Not available | 27 (7.7) | 26 (7.5) | 27 (7.7) |
| Macular perfusion status, n (%) | N=351 | N=347 | N=350 |
| Ischaemic† | 43 (12.3) | 31 (8.9) | 27 (7.7) |
| Non-ischaemic | 257 (73.2) | 260 (74.9) | 284 (81.1) |
| Not available | 51 (14.5) | 56 (16.1) | 39 (11.1) |
| Lens status, n (%) | N=351 | N=347 | N=350 |
| Phakic | 265 (75.5) | 259 (74.9) | 249 (71.1) |
| Pseudophakic | 86 (24.5) | 88 (25.4) | 101 (28.9) |
*DME classification based upon clinical assessment by the treating physician.
†Area of macular capillary loss on fluorescein angiography >0.5 disc areas. Analysis based on Fisher exact test.
Intergroup comparisons performed using Pearson's χ2 test (categorical variables) and a one-way analysis of variance model (continuous variables).
CSRT, central subfield retinal thickness; DEX implant, dexamethasone intravitreal implant; DME, diabetic macular oedema; ETDRS, Early Treatment Diabetic Retinopathy Study; HbA1c, glycosylated haemoglobin; ITT, intent-to-treat; NPDR, non-proliferative diabetic retinopathy; VEGF, vascular endothelial growth factor.