Table 3.
Vision and Morphological Outcomes for All Eyes and by Drug Assigned in the Clinical Trial
| Outcome | All (N=647) | Drug Assigned in the Clinical Trial | P-value | ||||
|---|---|---|---|---|---|---|---|
| Ranibizumab (N=328) | Bevacizumab (N= 319) | ||||||
| Visual acuity score, letters | |||||||
| Snellen equivalent, no. (%) | |||||||
| 83–97, 20/12–20 | 60 | ( 9.3) | 24 | ( 7.3) | 36 | (11.3) | |
| 68–82, 20/25–40 | 261 | (40.3) | 129 | (39.3) | 132 | (41.4) | |
| 53–67, 20/50–80 | 132 | (20.4) | 68 | (20.7) | 64 | (20.1) | |
| 38–52, 20/100–160 | 65 | (10.0) | 36 | (11.0) | 29 | ( 9.1) | |
| 37–18, 20/200–400 | 73 | (11.3) | 42 | (12.8) | 31 | ( 9.7) | |
| ≤17, ≤20/400 | 56 | ( 8.7) | 29 | ( 8.8) | 27 | ( 8.5) | |
| Mean letters (SD) | 58.9 | (24.1) | 57.7 | (42.1) | 60.2 | (24.1) | 0.19 |
| Change in visual acuity score, | |||||||
| from baseline, letters, no. (%) | |||||||
| ≥15 increase | 114 | (17.6) | 49 | (14.9) | 65 | (20.4) | |
| 5–14 increase | 156 | (24.2) | 76 | (23.2) | 80 | (25.0) | |
| ≤ 4 change | 142 | (21.9) | 76 | (23.2) | 66 | (20.7) | |
| 5–14 decrease | 82 | (12.7) | 48 | (14.6) | 34 | (10.7) | |
| 15–29 decrease | 71 | (11.0) | 37 | (11.3) | 34 | (10.7) | |
| ≥30 decrease | 82 | (12.7) | 42 | (12.8) | 40 | (12.5) | |
| Mean (SD) | -3.3 | (22.3) | -4.5 | (22.3) | -2.1 | (22.3) | 0.17 |
| Change in visual acuity score, | |||||||
| from 2 years, letters, no. (%)§ | |||||||
| ≥15 increase | 17 | ( 2.6) | 5 | ( 1.5) | 12 | ( 3.8) | |
| 5–14 increase | 60 | ( 9.3) | 28 | ( 8.6) | 32 | (10.0) | |
| ≤ 4 change | 215 | (33.4) | 101 | (31.1) | 114 | (35.8) | |
| 5–14 decrease | 167 | (26.0) | 90 | (27.7) | 77 | (24.2) | |
| 15–29 decrease | 101 | (15.7) | 48 | (14.8) | 53 | (16.7) | |
| ≥30 decrease | 83 | (12.9) | 53 | (16.3) | 30 | ( 9.4) | |
| Mean (SD) | -10.8 | (18.9) | -12.7 | (19.4) | -8.8 | (18.2) | 0.008 |
| Total thickness at fovea, μm | (N=555) | (N=277) | (N=278) | ||||
| Mean (SD)* | 278 | (160) | 267 | (145) | 289 | (174) | 0.11 |
| Mean Change(SD) from 2 years*** | -20 | (132) | -23 | (129) | -17 | 136 | 0.63 |
| Fluid on optical coherence tomography | |||||||
| None | 94 | (17.0) | 42 | (15.3) | 52 | (18.8) | 0.27 |
| Present | 458 | (83.0) | 233 | (84.7) | 225 | (81.2) | |
| Unknown/missing | 3 | 2 | 1 | ||||
| Dye leakage on angiogram | ((N**=527/467) | (N**=265/228) | (N**=262/239) | ||||
| None | 342 | (75.5) | 167 | (75.6) | 175 | (75.4) | 0.97 |
| Present | 111 | (24.5) | 54 | (24.4) | 57 | (24.6) | |
| Unknown/missing | 74 | 44 | 30 | ||||
| Area of lesion, mm2 | |||||||
| Mean (SD)‡ | 12.9 | (11.4) | 13.9 | (11.7) | 11.9 | (11.0) | 0.06 |
| Mean Change (SD) from 2years‡‡ | 4.8 | (8.8) | 5.6 | (9.9) | 4.2 | (7.6) | 0.10 |
| Geographic atrophy, no. (%) | |||||||
| None | 302 | (58.6) | 145 | (55.8) | 157 | (61.6) | 0.34 |
| Non-foveal | 128 | (24.9) | 67 | (25.8) | 61 | (23.9) | |
| Foveal | 85 | (16.5) | 48 | (18.5) | 37 | (14.5) | |
| Unknown/missing | 12 | 5 | 7 | ||||
§
4 Year 2 visual acuity scores missing; 3 in ranibizumab and 1 in bevacizumab group
*
3 missing in total thickness at Year 5; 2 in ranibizumab and 1 in bevacizumab
**
Number with color photographs/fluorescein angiograms
***
8 missing in change of total thickness from Year 2; 6 in ranibizumab and 2 in bevacizumab group
‡
34 with lesion area ungradable at Year 5; 15 ranibizumab and 19 in bevacizumab group
‡‡
53 with missing in change of area of lesion due to ungradable images at Year 2 or Year 5;, 29 in ranibizumab and 24 in bevacizumab group