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Table 3 Patient demographics for OCEAN and selected randomized controlled trials in the indication diabetic macular oedema

From: Demographics of patients receiving Intravitreal anti-VEGF treatment in real-world practice: healthcare research data versus randomized controlled trials

Study

Treatment group

N

Age mean ± SD (years)

Age range (years)

Gender, n (%)

BMI mean ± SD (kg/m2)

Diabetes type, n (%)

HbA1cmean ± SD (%)

Time since diagnosis of diabetes mean ± SD (years)

Time since diagnosis of DME mean ± SD (years)

Time since diagnosis of DME median [range] (years)

Baseline VA ETDRS letters analogue (mean ± SD) a

male

female

Type 1

Type 2

OCEAN b

Ranibizumab 0.5 mg

1211

67.6 ± 10.9

23-100

698 (57.6)

507 (41.9)

29.3 ± 5.2

116 (9.6)

936 (77.3)

7.5 ± 1.3

n. a.

0.68 ± 1.63 c, d

0.16 [0–16] d

60.6 ± 15.5

DRCR.net Protocol J [43] e

Sham injection + laser

123

54 (45,61) f

n. a.

n. a.

44 (36)

n. a.

20 (16)

101 (82)

7.9 (7.0, 9.6) f

15 (8, 21) f

n. a.

n. a.

67 (52, 75) f

Ranibizumab + laser

113

57 (48,64) f

n. a.

n. a.

48 (42)

n. a.

13 (12)

93 (82)

8.1 (7.1, 9.9) f

15 (10, 21) f

n. a.

n. a.

68 (56, 75) f

Triamcinolone + laser

109

58 (49,64) f

n. a.

n. a.

44 (40)

n. a.

12 (11)

95 (87)

8.1 (7.0, 9.7) f

15 (10, 19) f

n. a.

n. a.

67 (59, 75) f

DRCR.net Protocol I [44] g

Sham injection + prompt laser

293

63 (57,69) f

n. a.

n. a.

123 (42)

n. a.

25 (9)

260 (89)

7.3 (6.6, 8.3) f

16 (9, 22) f

n. a.

n. a.

65 (56, 73) f

Ranibizumab + prompt laser

187

62 (56,70) f

n. a.

n. a.

85 (45)

n. a.

11 (6)

172 (92)

7.3 (6.6, 8.4) f

18 (12, 24) f

n. a.

n. a.

66 (55, 72) f

Ranibizumab + deferred laser

188

64 (58,70) f

n. a.

n. a.

78 (41)

n. a.

15 (8)

170 (90)

7.5 (6.7, 8.4) f

17 (11, 22) f

n. a.

n. a.

66 (58, 72) f

Triamcinolone + prompt laser

186

62 (55,70) f

n. a.

n. a.

86 (46)

n. a.

14 (8)

166 (89)

7.4 (6.5, 8.6) f

17 (11, 24) f

n. a.

n. a.

66 (57, 72) f

BOLT [45]

Bevacizumab

42

64.9 ± 9.4

n. a.

30 h

12 h

n. a.

4

38

7.6 ± 1.4

13.5 i

n. a.

2 [1.5-4] i

55.7 ± 9.7

Laser

38

63.5 ± 8.1

n. a.

25 h

13 h

n. a.

4

34

7.5 ± 1.2

14.8 i

n. a.

3 [2–4.6] i

54.6 ± 8.6

RISE [46] k

Sham injections

127

61.8 ± 9.8

39-85

74 (58.3)

n. a.

31.4 ± 7.1

n. a.

n. a.

7.7 ± 1.5

14.5 ± 9.9

2.3 ± 3.0 m

n. a.

57.2 ± 11.11

Ranibizumab 0.3 mg

125

61.7 ± 8.9

38-82

73 (58.4)

n. a.

32.3 ± 6.8

n. a.

n. a.

7.7 ± 1.5

15.9 ± 9.9

2.1 ± 2.2 m

n. a.

54.7 ± 12.6

Ranibizumab 0.5 mg

125

62.8 ± 10.0

21-87

65 (52.0)

n. a.

32.9 ± 8.5

n. a.

n. a.

7.7 ± 1.4

16.3 ± 8.5

2.1 ± 2.1 m

n. a.

56.9 ± 11.6

RIDE [46] n

Sham injections

130

63.5 ± 10.8

22-91

66 (50.8)

n. a.

32.3 ± 8.9

n. a.

n. a.

7.6 ± 1.4

16.6 ± 10.6

2.4 ± 3.2 m

n. a.

57.3 ± 11.2

Ranibizumab 0.3 mg

125

62.7 ± 11.1

24-88

73 (58.4)

n. a.

32.3 ± 8.6

n. a.

n. a.

7.6 ± 1.3

16.0 ± 9.8

1.6 ± 2.0 m

n. a.

57.5 ± 11.6

Ranibizumab 0.5 mg

127

61.8 ± 10.1

29-84

80 (63.0)

n. a.

31.3 ± 7.2

n. a.

n. a.

7.6 ± 1.5

15.3 ± 10.1

1.9 ± 2.4 m

n. a.

56.9 ± 11.8

RESTORE [47]

Ranibizumab 0.5 mg + sham laser

116

62.9 ± 9.29

n. a.

73 (62.9)

43 (37.1)

n. a.

13 (11.2)

103 (88.8)

n. a. o

15.23 ± 9.91

1.80 ± 1.98

n. a.

64.8 ± 10.11

Ranibizumab 0.5 mg + laser

118

64.0 ± 8.15

n. a.

70 (59.3)

48 (40.7)

n. a.

15 (12.7)

102 (86.4)

n. a. o

14.62 ± 9.84

1.99 ± 3.14

n. a.

63.4 ± 9.99

Laser + sham injection

111

63.5 ± 8.81

n. a.

58 (52.3)

53 (47.7)

n. a.

13 (11.7)

97 (87.4)

n. a. o

12.93 ± 9.02

1.58 ± 1.96

n. a.

62.4 ± 11.11

VISTA [48]

Laser photo-coagulation + sham injection

154

61.7 ± 8.7

n. a.

n. a.

69 (44.8)

n. a.

n. a.

n. a.

7.6 ± 1.7

17.2 ± 9.5

n. a.

n. a.

59.7 ± 10.9

Aflibercept 2 mg 2q4

154

62.0 ± 11.2

n. a.

n. a.

67 (43.5)

n. a.

n. a.

n. a.

7.9 ± 1.6

16.5 ± 9.9

n. a.

n. a.

58.9 ± 10.8

Aflibercept 2 mg 2q8

151

63.1 ± 9.4

n. a.

n. a.

73 (48.3)

n. a.

n. a.

n. a.

7.9 ± 1.6

17.6 ± 11.5

n. a.

n. a.

59.4 ± 10.9

VIVID [48]

Laser photo-coagulation + sham injection

132

63.9 ± 8.6

n. a.

n. a.

54 (40.9)

n. a.

n. a.

n. a.

7.7 ± 1.3

14.5 ± 9.8

n. a.

n. a.

60.8 ± 10.6

Aflibercept 2 mg 2q4

136

62.6 ± 8.6

n. a.

n. a.

53 (39.0)

n. a.

n. a.

n. a.

7.8 ± 1.5

14.3 ± 9.2

n. a.

n. a.

60.8 ± 10.7

Aflibercept 2 mg 2q8

135

64.2 ± 7.8

n. a.

n. a.

47 (34.8)

n. a.

n. a.

n. a.

7.7 ± 1.4

14.1 ± 8.9

n. a.

n. a.

58.8 ± 11.2

DRCR.net Protocol T [49] p

Aflibercept

224

60 ± 10

n. a.

n. a.

110 (49)

31.8 (27.4, 37.3) f

22 (10)

196 (88)

7.6 (6.8, 9.1) f

15 (8, 21) f

n. a.

n. a.

69 (59, 74) f

Bevacizumab

218

62 ± 10

n. a.

n. a.

103 (47)

32.9 (28.7, 37.6) f

12 (6)

205 (94)

7.7 (6.8, 8.8) f

17 (11, 24) f

n. a.

n. a.

69 (60, 72) f

Ranibizumab

218

60 ± 11

n. a.

n. a.

94 (43)

32.3 (28.2, 37.2) f

16 (7)

196 (90)

7.8 (6.9, 9.2) f

16 (11, 23) f

n. a.

n. a.

68 (58, 73) f

  1. a Method of measuring baseline VA not always explained in sources. Direct comparisons of VA results may not be reliable
  2. b Missing values in OCEAN: age: 9 patients; gender: 6; BMI: 87; diabetes type: 69; HbA1c: 491; time since diagnosis: 65; baseline VA: 8
  3. c Time since diagnosis until first injection in OCEAN
  4. d Results converted to years (from days)
  5. e Missing values in Protocol J (sham, ranibizumab, triamcinolone group): HbA1c: 3, 10, 6 patient (s)
  6. f Given as median (25th, 75th percentile)
  7. g Missing values in Protocol I (sham, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone group): HbA1c: 17, 3, 7, 8 patient(s)
  8. h No percentage available
  9. i Results converted to years (from months)
  10. k Missing values in RISE (sham, 0.3 mg, 0.5 mg group): BMI: 3, 3, 1 patient(s); time since diagnosis of diabetes: 4, 7, 7; HbA1c: 4, 5, 5; time since diagnosis of DME: 0, 1, 2
  11. m Time from clinically significant macular oedema to randomization
  12. n Missing values in RIDE (sham, 0.3 mg, 0.5 mg group): BMI: 2, 0, 1 patient(s); time since diagnosis of diabetes: 8, 6, 3; HbA1c: 5, 5, 4; time since diagnosis of DME: 0, 0, 1
  13. o HbA1c ≤10% inclusion criterion
  14. p Missing values in Protocol T (aflibercept, bevacizumab, ranibizumab group): diabetes type: 6, 1, 6 patients; HbA1c: 5, 0, 1 patient(s); BMI: 17, 22, 23 patients
  15. Abbreviations: 2q4: monthly until week 48; 2q8: monthly until week 16 then every 8 weeks through week 48; BMI: body mass index; DME: diabetic macular oedema; DRCR.net: Diabetic Retinopathy Clinical Research Network; ETDRS: Early Treatment Diabetic Retinopathy Study; HbA1c: glycated haemoglobin (type A1c); N: total number of patients; n: number of patients; n. a.: data not available in source; SD: standard deviation; VA: visual acuity