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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