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Table 1 Demographics and baseline characteristics (safety analysis set)

From: Primary outcomes of the VIDI study: phase 2, double-masked, randomized, active-controlled study of ASP8232 for diabetic macular edema

Parameter ASP8232 (n = 32) ASP8232/ranibizumab (n = 33) Ranibizumab (n = 31) Total (n = 96)
Sex
Male 17 (53.1) 15 (45.5) 16 (51.6) 48 (50.0)
Female 15 (46.9) 18 (54.5) 15 (48.4) 48 (50.0)
Ethnicity
Not Hispanic or Latino 21 (65.6) 18 (54.5) 24 (77.4) 63 (65.6)
Hispanic or Latino 11 (34.4) 15 (45.5) 7 (22.6) 33 (34.4)
Race
White/Caucasian 26 (81.3) 27 (81.8) 22 (71.0) 75 (78.1)
Black/African American 4 (12.5) 5 (15.2) 5 (16.1) 14 (14.6)
Asian 1 (3.1) 0 1 (3.2) 2 (2.1)
American Indian/Alaskan native 0 0 2 (6.5) 2 (2.1)
Other 1 (3.1) 1 (3.0) 1 (3.2) 3 (3.1)
Age, y
Mean (SD) 61.5 (8.1) 59.8 (9.2) 63.4 (8.6) 61.5 (8.7)
Median 61.5 60.0 65.0 62.0
Range 47–82 30–81 45–78 30–82
Age group (years)
≤ 64 22 (68.8) 22 (66.7) 14 (45.2) 58 (60.4)
≥ 65 10 (31.3) 11 (33.3) 17 (54.8) 38 (39.6)
EudraCT age category (years)
≥ 18 to ≤ 64 22 (68.8) 22 (66.7) 14 (45.2) 58 (60.4)
≥ 65 to ≤ 84 10 (31.3) 11 (33.3) 17 (54.8) 38 (39.6)
≥ 85 0 0 0 0
Weight, kg
Mean (SD) 87.66 (19.79) 92.68 (25.33) 92.42 (20.37) 90.92 (21.91)
Median 86.85 83.60 88.20 86.40
Range 53.2–139.5 61.4–157.7 55.9–140.9 53.2–157.7
Height, cm
Mean (SD) 165.74 (9.13) 167.53 (11.31) 167.58 (8.78) 166.95 (9.76)
Median 166.82 167.64 165.10 165.55
Range 146.05–182.88 149.86–190.50 152.40–187.96 146.05–190.50
BMI, kg/m 2
Mean (SD) 31.92 (6.99) 32.70 (6.80) 33.06 (7.76) 32.56 (7.13)
Median 29.40 30.50 31.10 30.60
Range 21.5–51.1 24.5–54.5 21.8–53.3 21.5–54.5
Study eye
Left 12 (37.5) 20 (60.6) 14 (45.2) 46 (47.9)
Right 20 (62.5) 13 (39.4) 17 (54.8) 50 (52.1)
Number of qualified eyes
1 25 (78.1) 30 (90.9) 27 (87.1) 82 (85.4)
2 7 (21.9) 3 (9.1) 4 (12.9) 14 (14.6)
CST, study eye (µm)
Mean (SD) 535.8 (117.9) 508.2 (104.3) 501.6 (105.5) 515.3 (109.3)
Median 522.0 489.0 488 490.0
Range 367–809 356–827 348–824 348–827
CST stratification (µm)
≤ 500 16 (50.0) 18 (54.5) 16 (51.6) 50 (52.1)
> 500 16 (50.0) 15 (45.5) 15 (48.4) 46 (47.9)
ETDRS-BCVA, study eye (letters)
Mean (SD) 59 (10.1) 59.9 (10.8) 57.7 (14.7) 58.9 (11.9)
Median 61.5 63.0 64.0 63.0
Range 34–78 32–73 9–75 9–78
Iris color
Blue 7 (21.9) 5 (15.2) 6 (19.4) 18 (18.8)
Green 1 (3.1) 1 (3.0) 1 (3.2) 3 (3.1)
Brown 20 (62.5) 25 (75.8) 17 (54.8) 62 (64.6)
Hazel 4 (12.5) 2 (6.1) 6 (19.4) 12 (12.5)
Other 0 0 1 (3.2) 1 (1.0)
Smoking history
Never 22 (68.8) 20 (60.6) 20 (64.5) 62 (64.6)
Current 2 (6.3) 1 (3.0) 2 (6.5) 5 (5.2)
Former 8 (25.0) 12 (36.4) 9 (29.0) 29 (30.2)
Smoking duration, y
n 10 13 11 34
Mean (SD) 21.8 (15.8) 20.5 (11.1) 18.5 (11.8) 20.2 (12.5)
Median 29.5 20.0 20.0 20.0
Range 0–42 2–35 1–40 0–42
Diabetic medication
Metformin 16 (50.0) 15 (45.5) 16 (51.6) 47 (49.0)
DPP-4 inhibitors 5 (15.6) 6 (18.2) 2 (6.5) 13 (13.5)
Insulin for inhalation 1 (3.1) 3 (9.1) 6 (19.4) 10 (10.4)
Insulin, fast-acting 11 (34.4) 10 (30.3) 14 (45.2) 35 (36.5)
Insulin, long-acting 15 (46.9) 16 (48.5) 17 (54.8) 48 (50.0)
Insulins/combinations 14 (43.8) 8 (24.2) 15 (48.4) 37 (38.5)
Sulfonylureas 11 (34.4) 10 (30.3) 11 (35.5) 32 (33.3)
Previous eye medications
Study eye 5 (15.6) 5 (15.2) 5 (16.1) 15 (15.6)
Fellow eye 5 (15.6) 6 (18.2) 8 (25.8) 19 (19.8)
Ocular interventions, study eye
Focal laser 7 (21.9) 6 (18.2) 4 (12.9) 17 (17.7)
Panretinal photocoagulation 5 (15.6) 4 (12.1) 5 (16.1) 14 (14.6)
Cataract/Phacoemulsification 4 (12.5) 3 (9.1) 8 (25.8) 15 (15.6)
YAG capsulotomy 1 (3.1) 1 (3.0) 0 2 (2.1)
  1. Data are presented as n (%) unless otherwise noted
  2. BCVA best-corrected visual acuity, BMI body mass index, DPP-4 dipeptidyl peptidase 4 inhibitors, ETDRS early treatment diabetic retinopathy study