Table 1. Baseline Participant and Study Eye Characteristics.
| Baseline characteristicsa | No. (%) | |
|---|---|---|
| Aflibercept (n = 200) | Sham (n = 199) | |
| Study eyes laterality | ||
| Unilateral | 129 (64.5) | 128 (64.3) |
| Bilateral | 71 (35.5) | 71 (35.7) |
| Female sex | 83 (41.5) | 86 (43.2) |
| Male sex | 117 (58.5) | 113 (56.8) |
| Age, y | ||
| Mean (SD) | 56.6 (10.1) | 55.0 (10.6) |
| Median (IQR) | 57 (51-63) | 56 (48-62) |
| Race and ethnicity | ||
| American Indian or Alaska Native | 1 (<1) | 0 |
| Asian | 10 (5.0) | 9 (4.5) |
| Black or African American | 29 (14.5) | 32 (16.1) |
| Hispanic or Latino | 62 (31.0) | 67 (33.7) |
| More than 1 race | 3 (1.5) | 1 (<1) |
| Native Hawaiian or Other Pacific Islander | 1 (<1) | 1 (<1) |
| Unknown or not reported | 2 (1.0) | 3 (1.5) |
| White | 92 (46.0) | 86 (43.2) |
| Diabetes | ||
| Type 1 | 12 (6.0) | 23 (11.6) |
| Type 2 | 188 (94.0) | 176 (88.4) |
| Duration, y | ||
| Mean (SD) | 16.4 (8.9) | 17.3 (9.7) |
| Median (IQR) | 17 (10-22) | 16 (11-22) |
| Insulin used | 139 (69.5) | 139 (69.8) |
| Hemoglobin A1c, %b | ||
| Mean (SD) | 8.8 (2.2) | 8.7 (2.0) |
| Median (IQR) | 8.6 (7.1-10.0) | 8.3 (7.3-9.7) |
| Mean arterial blood pressure, mm Hg | ||
| Mean (SD) | 99.7 (11.2) | 98.9 (11.2) |
| Median (IQR) | 100 (92-107) | 98 (91-106) |
| Body mass indexc | ||
| Mean (SD) | 32.9 (6.9) | 32.2 (6.6) |
| Median (IQR) | 31 (28-37) | 31 (27-36) |
| Prior myocardial infarction | 16 (8.0) | 19 (9.5) |
| Prior stroke | 13 (6.5) | 11 (5.5) |
| Preexisting kidney disease | 6 (3.0) | 6 (3.0) |
| Study eye characteristics | ||
| Visual acuity (best-corrected ETDRS)d | ||
| Mean (SD), letter score | 87.4 (4.5) | 87.9 (4.6) |
| Median (IQR), letter score | 88 (84-90) | 88 (85-91) |
| Median, Snellen equivalent | 20/20 | 20/20 |
| 20/20 or better (≥84 letters) | 156 (78.0) | 161 (80.9) |
| OCT machinee | ||
| Heidelberg Spectralis | 111 (55.5) | 112 (56.3) |
| Zeiss Cirrus | 89 (44.5) | 87 (43.7) |
| OCT central subfield thickness, μmf | ||
| Mean (SD) | 281 (26) | 280 (24) |
| Median (IQR) | 283 (264-300) | 283 (265-299) |
| OCT retinal volume, mm3g,h | ||
| Mean (SD) | 7.4 (0.7) | 7.4 (0.7) |
| Median (IQR) | 7.4 (7.0-7.9) | 7.4 (6.9-7.8) |
| Diabetic retinopathy severity score | ||
| Moderate NPDR (level 43) | 33 (16.5) | 35 (17.6) |
| Moderately severe NPDR (level 47A) | 65 (32.5) | 61 (30.7) |
| Moderately severe NPDR (level 47B-D) | 54 (27.0) | 55 (27.6) |
| Severe NPDR (level 53) | 48 (24.0) | 48 (24.1) |
| Intraocular pressure, mm Hgi | ||
| Mean (SD) | 15.3 (3.1) | 15.1 (3.1) |
| Median (IQR) | 15 (13-17) | 15 (13-17) |
| Lens status | ||
| Phakic (natural lens) | 166 (83.0) | 167 (83.9) |
| Posterior chamber intraocular lens (surgically replaced lens) | 34 (17.0) | 32 (16.1) |
| Noncentral DMEj,k | 75 (39.9) | 83 (42.6) |
| Prior treatment for DMEl | 19 (9.5) | 22 (11.1) |
| Prior anti-VEGF for DME | 8 (4.0) | 5 (2.5) |
| Prior focal/grid laser for DME | 12 (6.0) | 19 (9.5) |
Abbreviations: DME, diabetic macular edema; ETDRS, Early Treatment Diabetic Retinopathy Study; NPDR, nonproliferative diabetic retinopathy; OCT, optical coherence tomography; VEGF, vascular endothelial growth factor.
All baseline characteristics reflect data collected at the randomization visit except for diabetic retinopathy severity, which was collected on fundus photos at the screening visit.
Values for hemoglobin A1c were missing for 11 aflibercept and 9 sham participants.
Calculated as weight in kilograms divided by height in meters squared.
Visual acuity letter score measured after protocol-defined refraction using an electronic ETDRS test (range, 0 [worst] to 100 [best] letters [Snellen equivalent of <20/800 to 20/10]).
Technology uses light waves to obtain cross-sectional images of the retina.
Heidelberg Spectralis machine equivalent (normative mean ≈ 262 μm for females; 278 μm for males).8
Values for OCT retinal volume were missing for 12 aflibercept and 4 sham eyes.
Intraocular pressure is the fluid pressure inside the eye measured with a tonometry test (normative mean ≈ 15 mm Hg).10
Indicates at least 2 noncentral macular subfields with OCT thickness above threshold (mean [SD] 2) or at least 1 noncentral macular subfield with OCT thickness at least 15 μm above threshold (mean [SD] 2).
Values for noncentral DME status were missing for 12 aflibercept and 4 sham eyes.
Indicates no treatment for DME or retinopathy in the 12 months preceding baseline.