Table. Participant Characteristics.
| Characteristic | No. (%) | |||
|---|---|---|---|---|
| Total | Control groupa | Aflibercept 2q16 groupb | Aflibercept 2q8/PRN groupc | |
| Total participants, No. | 402 | 133 | 135 | 134 |
| Participants completing week 52 | 355 (88.3) | 109 (82.0) | 122 (90.4) | 124 (92.5) |
| Participants completing week 100 | 320 (79.6) | 97 (72.9) | 111 (82.2) | 112 (83.6) |
| Age, mean (SD), y | 55.7 (10.5) | 55.8 (10.3) | 55.4 (11.1) | 55.8 (10.2) |
| Sex | ||||
| Male | 225 (56.0) | 69 (51.9) | 75 (55.6) | 81 (60.4) |
| Female | 177 (44.0) | 64 (48.1) | 60 (44.4) | 53 (39.6) |
| Race | ||||
| White | 310 (77.1) | 107 (80.5) | 99 (73.3) | 104 (77.6) |
| Black or African American | 41 (10.2) | 13 (9.8) | 16 (11.9) | 12 (9.0) |
| Asian | 23 (5.7) | 4 (3.0) | 12 (8.9) | 7 (5.2) |
| Otherd | 28 (7.0) | 9 (6.8) | 8 (5.9) | 11 (8.2) |
| Glycated hemoglobin A1c, mean (SD), % | 8.5 (1.6) | 8.5 (1.5) | 8.6 (1.7) | 8.4 (1.6) |
| Duration of diabetes, mean (SD), y | 14.4 (9.2) | 15.5 (9.3) | 13.7 (8.6) | 14.0 (9.7) |
| Diabetes | ||||
| Type 1 | 34 (8.5) | 10 (7.5) | 14 (10.4) | 10 (7.5) |
| Type 2 | 368 (91.5) | 123 (92.5) | 121 (89.6) | 124 (92.5) |
| Best-corrected visual acuity ETDRS letter score, mean (SD) | 82.4 (6.0) | 82.7 (6.0) | 82.2 (6.6) | 82.3 (5.2) |
| Snellen equivalent | 20/25 | 20/25 | 20/25 | 20/25 |
| Central subfield thickness, mean (SD), μm | 247.4 (34.8) | 249.4 (38.4) | 246.0 (34.3) | 246.8 (31.6) |
| DRSS level | ||||
| 47 | 302 (75.1) | 99 (74.4) | 102 (75.6) | 101 (75.4) |
| 53 | 100 (24.9) | 34 (25.6) | 33 (24.4) | 33 (24.6) |
Abbreviations: DRSS, Diabetic Retinopathy Severity Scale; ETDRS, Early Treatment Diabetic Retinopathy Study; PRN, pro re nata.
a
The control group received sham injections.
b
The aflibercept 2q16 group received intravitreal injections of aflibercept, 2 mg, every 16 weeks after 3 initial monthly doses and one 8-week interval.
c
The aflibercept 2q8/PRN group received intravitreal injections of aflibercept, 2 mg, every 8 weeks after 5 initial monthly doses, with PRN dosing beginning at week 56.
d
Specific races included in this category were not specified.