Table 1 Demographics and baseline characteristics (safety analysis set)

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)