Table 1. Visual Acuity and OCT Outcomes Through 24 Weeks by Presence of Persistent Diabetic Macular Edema.
| Characteristic | Eyes With Persistent DME Through 24 Weeks | Eyes Without Persistent DME Through 24 Weeks | ||||
|---|---|---|---|---|---|---|
| Aflibercept (n = 60) |
Bevacizumab (n = 118) |
Ranibizumab (n = 73) |
Aflibercept (n = 130) |
Bevacizumab (n = 62) |
Ranibizumab (n = 103) |
|
| Baseline visual acuity | ||||||
| Letter score, median (IQR) | 68 (74 to 60) | 69 (73 to 59) | 69 (73 to 64) | 70 (74 to 59) | 68 (72 to 62) | 69 (73 to 58) |
| Approximate Snellen equivalent, median (IQR) | 20/50 (20/32 to 20/63) | 20/40 (20/40 to 20/63) | 20/40 (20/40 to 20/50) | 20/40 (20/32 to 20/63) | 20/50 (20/40 to 20/63) | 20/40 (20/40 to 20/80) |
| 24-wk Visual acuitya | ||||||
| Letter score, median (IQR) | 78 (83 to 72) | 77 (82 to 68) | 77 (81 to 71) | 79 (85 to 74) | 76 (81 to 72) | 79 (84 to 73) |
| Approximate Snellen equivalent, median (IQR) | 20/32 (20/25 to 20/40) | 20/32 (20/25 to 20/50) | 20/32 (20/25 to 20/40) | 20/25 (20/20 to 20/32) | 20/32 (20/25 to 20/40) | 20/32 (20/20 to 20/40) |
| 20/25 or Better, No. (%) | 29 (48.3) | 47 (39.8) | 25 (34.2) | 68 (52.3) | 19 (30.6) | 51 (50.0) |
| 20/32 to 20/40, No. (%) | 19 (31.7) | 41 (34.7) | 33 (45.2) | 48 (36.9) | 33 (53.2) | 29 (28.4) |
| 20/50 to 20/80, No. (%) | 8 (13.3) | 24 (20.3) | 9 (12.3) | 11 (8.5) | 7 (11.3) | 17 (16.7) |
| 20/100 to 20/160, No. (%) | 3 (5.0) | 4 (3.4) | 5 (6.8) | 3 (2.3) | 3 (4.8) | 5 (4.9) |
| 20/200 or Worse, No. (%) | 1 (1.7) | 2 (1.7) | 1 (1.4) | 0 | 0 | 0 |
| 24-wk Change in visual acuity letter score from baselinea | ||||||
| Median (IQR) | 9 (5 to 15) | 9 (3 to 14) | 7 (3 to 11) | 12 (6 to 19) | 10 (4 to 14) | 12 (7 to 18) |
| Mean (SD)b | 9.9 (8.8) | 8.8 (8.7) | 8.0 (8.4) | 13.2 (10.0) | 9.6 (8.6) | 12.3 (8.4) |
| ≥15-Letter gain, No. (%)c | 17 (28.3) | 24 (20.3) | 11 (15.1) | 52 (40.0) | 14 (22.6) | 35 (34.3) |
| 10-14–Letter gain, No. (%)c | 10 (16.7) | 32 (27.1) | 16 (21.9) | 30 (23.1) | 18 (29.0) | 27 (26.5) |
| 5-9–Letter gain, No. (%) | 19 (31.7) | 25 (21.2) | 22 (30.1) | 25 (19.2) | 11 (17. 7) | 27 (26.5) |
| Within 4 letters, No. (%) | 12 (20.0) | 32 (27.1) | 21 (28.8) | 22 (16.9) | 15 (24.2) | 11 (10.8) |
| 5-9–Letter loss, No. (%) | 0 | 3 (2.5) | 2 (2.7) | 1 (0.8) | 3 (4.8) | 2 (2.0) |
| 10-14–Letter loss, No. (%)d | 2 (3.3) | 1 (0.8) | 1 (1.4) | 0 | 1 (1.6) | 0 |
| ≥15-Letter loss, No. (%)d | 0 | 1 (0.8) | 0 | 0 | 0 | 0 |
| 104-wk Change in visual acuity letter score from baselinee | ||||||
| Median (IQR) | 13 (4 to 19) | 10 (3 to 16) | 10 (6 to 18) | 13 (6 to 20) | 14 (5 to 18) | 13 (7 to 18) |
| Mean (SD) | 12.4 (10.7) | 9.5 (10.6) | 11.7 (10.8) | 13.5 (13.0) | 11.2 (12.4) | 13.3 (10.3) |
| Change in visual acuity letter score from 24-wk visit to 104-wk visita,e | ||||||
| Median (IQR) | 2 (−3 to 7) | 2 (−5 to 5) | 4 (−1 to 7) | 1 (−3 to 6) | 2 (−3 to 6) | 1 (−3 to 5) |
| Mean (SD) | 2.5 (9.5) | 1.1 (9.3) | 3.4 (9.2) | 0.8 (8.5) | 1.4 (9.2) | 1.2 (8.9) |
| Baseline central subfield thickness, median (IQR), μm | 412 (360 to 470) | 413 (343 to 511) | 427 (363 to 506) | 365 (291 to 462) | 327 (282 to 428) | 355 (295 to 472) |
| 24-wk Central subfield thickness, median (IQR), μmf | 306 (277 to 345) | 348 (297 to 424) | 333 (280 to 398) | 213 (193 to 236) | 224 (200 to 243) | 219 (194 to 242) |
| 24-wk Change in central subfield thickness, median (IQR), μm | −94 (−149 to −65) | −49 (−106 to −6) | −87 (−133 to −23) | −143 (−251 to −74) | −102 (−198 to −48) | −133 (−242 to −68) |
| Central-involved DME, No. (%)g | 60 (100) | 118 (100) | 73 (100) | 7 (5.4) | 9 (14.5) | 12 (11.7) |
| Baseline retinal volume, median (IQR), μLh | 8.2 (7.7 to 9.9) | 8.4 (7.5 to 9.9) | 8.7 (7.8 to 10.0) | 8.4 (7.5 to 10.3) | 8.2 (7.4 to 10.5) | 9.0 (7.7 to 9.7) |
| 24-wk Retinal volume, median (IQR), μLi | 7.5 (7.1 to 8.3) | 7.9 (7.2 to 9.3) | 7.8 (7.3 to 8.8) | 7.1 (6.7 to 7.6) | 7.5 (6.8 to 8.1) | 7.2 (6.7 to 7.6) |
| 24-wk Change in retinal volume, median (IQR), μLj | −0.9 (−1.7 to −0.6) | −0.5 (−1.0 to −0.1) | −0.8 (−1.4 to −0.3) | −1.2 (−2.5 to −0.6) | −1.1 (−2.5 to −0.5) | −1.5 (−2.7 to −0.8) |
Abbreviations: DME, diabetic macular edema; IQR, interquartile range; OCT, optical coherence tomography.
24-week visual acuity unavailable for 1 eye without persistent DME, ranibizumab group.
Adjusted difference for without-with persistent DME were 3.1 (95% CI, 0.7 to 5.5; P = .01) for aflibercept; 0.7 (95% CI, −1.8 to 3.1; P = .59) for bevacizumab; and 3.7 (95% CI, 1.4 to 6.0; P = .002) for ranibizumab.
For gain ≥10 letters with vs without persistent DME, P = .02 for aflibercept, P = .65 for bevacizumab, and P = .005 for ranibizumab.
For loss ≥10 letters with vs without persistent DME, P = .10 for aflibercept, P > .99 for bevacizumab, and P = .42 for ranibizumab (Fisher exact test).
104-week visual acuity unavailable for 0, 10, and 6 eyes with persistent DME and 7, 4, and 5 eyes without persistent DME in the aflibercept, bevacizumab, and ranibizumab groups, respectively.
For 1 eye in the ranibizumab group with persistent DME that completed the 24-week visit, central subfield thickness was unavailable, so the last available (20-week) central subfield thickness measurement was imputed for 24 weeks.
Central-involved DME on OCT at the visit. For Heidelberg Spectralis machines, this was defined as central subfield thickness at least 305 μm for women and at least 320 μm for men. For Zeiss Cirrus machines, this was defined as central subfield thickness at least 290 μm for women and at least 305 μm for men. For Zeiss Stratus machines, this was defined as central subfield thickness at least 250 μm for both sexes.
Baseline retinal volume was unavailable for 9, 19, and 12 eyes with persistent DME and 24, 9, and 16 eyes without persistent DME in the aflibercept, bevacizumab, and ranibizumab groups, respectively.
24-week retinal volume was unavailable for 0, 2, and 1 eyes with persistent DME and 2, 2, and 1 eyes without persistent DME in the aflibercept, bevacizumab, and ranibizumab groups, respectively.
24-week change in retinal volume was unavailable for 9, 21, and 13 eyes with persistent DME and 26, 10, and 16 eyes without persistent DME in the aflibercept, bevacizumab, and ranibizumab groups, respectively.