Table 2.
Outcomes at Two Years - Patients Treated with the Same Dosing Regimen for 2 Years
| Ranibizumab | Bevacizumab | Ranibizumab | Bevacizumab | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Monthly | Monthly | as Needed | as Needed | P | ||||||
| Outcome | N=134 | N=129 | N=264 | N=251 | Drug | Regimen | ||||
| Visual acuity score, letters, Snellen equivalent, no. (%) | ||||||||||
| 83–97, 20/12–20 | 24 | (17.9) | 17 | (13.2) | 44 | (16.7) | 35 | (13.9) | ||
| 68–82, 20/25–40 | 67 | (50.0) | 61 | (47.3) | 123 | (46.6) | 121 | (48.2) | ||
| 53–67, 20/50–80 | 23 | (17.2) | 31 | (24.0) | 59 | (22.3) | 46 | (18.3) | ||
| 38–52, 20/100–160 | 11 | ( 8.2) | 14 | (10.9) | 23 | ( 8.7) | 28 | (11.2) | ||
| ≤37, ≤20/200 | 9 | ( 6.7) | 6 | ( 4.7) | 15 | ( 5.7) | 21 | ( 8.4) | ||
| Mean letters (SD)* | 68.5 | (18.9) | 68.2 | (16.1) | 68.5 | (15.3) | 66.0 | (19.9) | 0.17 | 0.41 |
| Change in visual acuity score, from baseline, letters, no. (%) | ||||||||||
| ≥ 15 increase | 44 | (32.8) | 41 | (31.8) | 81 | (30.7) | 71 | (28.3) | ||
| 5–14 increase | 49 | (36.6) | 36 | (27.9) | 78 | (29.5) | 79 | (31.5) | ||
| ≤ 4 change | 22 | (16.4) | 31 | (24.0) | 62 | (23.5) | 49 | (19.5) | ||
| 5–14 decrease | 10 | ( 7.5) | 11 | ( 8.5) | 24 | ( 9.1) | 23 | ( 9.2) | ||
| ≥ 15 decrease | 9 | ( 6.7) | 10 | ( 7.8) | 19 | ( 7.2) | 29 | (11.6) | ||
| Mean (SD) | 8.8 | (15.9) | 7.8 | (15.5) | 6.7 | (14.6) | 5.0 | (17.9) | 0.21 | 0.046 |
| Mean (SD) no. treatments, 2 years | 22.4 | (3.9) | 23.4 | (2.8) | 12.6 | (6.6) | 14.1 | (7.0) | 0.01† | -- |
| Mean cost of drug/patient | $44,800 | $1,170 | $25,200 | $705 | ||||||
| Total thickness at fovea, µm | ||||||||||
| Mean (SD)** | 267 | (143) | 274 | (137) | 293 | (129) | 306 | (134) | 0.26 | 0.005 |
| Mean Change(SD) from baseline*** | −190 | (172) | −180 | (196) | −166 | (190) | −153 | (189) | 0.38 | 0.08 |
| Retinal thickness and subfoveal fluid thickness, µm | ||||||||||
| Mean (SD)** | 162 | (81) | 166 | (79) | 167 | (75) | 169 | (83) | 0.63 | 0.53 |
| Mean Change(SD) from baseline*** | −91 | (152) | −84 | (133) | −78 | (131) | −84 | (145) | 0.86 | 0.54 |
| Fluid on optical coherence tomography, no. (%) | ||||||||||
| None | 61 | (45.5) | 39 | (30.2) | 59 | (22.3) | 35 | (13.9) | 0.0003 | <0.0001 |
| Present | 69 | (51.5) | 87 | (67.4) | 198 | (75.0) | 212 | (84.5) | ||
| Unknown/missing | 4 | ( 3.0) | 3 | ( 2.3) | 7 | ( 2.7) | 4 | ( 1.6) | ||
| Dye leakage on angiogram, no. (%) | ||||||||||
| None | 102 | (76.1) | 97 | (75.2) | 183 | (69.3) | 161 | (64.1) | 0.24 | 0.002 |
| Present | 24 | (17.9) | 27 | (20.9) | 75 | (28.4) | 81 | (32.3) | ||
| Unknown/missing | 8 | ( 6.0) | 5 | ( 3.9) | 6 | ( 2.3) | 9 | ( 3.6) | ||
| Area of lesion, mm2 | ||||||||||
| Mean (SD)‡ | 6.7 | (7.8) | 7.8 | (8.5) | 8.5 | (7.4) | 8.6 | (8.3) | 0.44 | 0.04 |
| Mean Change (SD) from baseline‡‡ | −0.4 | (6.8) | 1.6 | (5.9) | 1.9 | (6.5) | 3.0 | (7.0) | 0.006 | 0.0003 |
| Geographic atrophy±, no. (%) | ||||||||||
| None | 90 | (70.3) | 99 | (80.5) | 205 | (84.0) | 200 | (85.8) | 0.13 | 0.007 |
| Non-foveal | 27 | (21.1) | 17 | (13.8) | 28 | (11.5) | 20 | ( 8.6) | ||
| Foveal | 6 | ( 4.7) | 5 | ( 4.1) | 9 | ( 3.7) | 10 | ( 4.3) | ||
| Unknown/missing | 5 | ( 3.9) | 2 | ( 1.6) | 2 | ( 0.8) | 3 | ( 1.3) | ||
SD is standard deviation
Number in each group unknown or missing: 3, 3, 3, 1;
Number in each group unknown or missing: 3, 3, 6, 2;
Includes choroidal neovascularization, hemorrhage, blocked fluorescence, serous pigment epithelium detachment, scar, geographic atrophy, non-geographic atrophy or tear of the retinal pigment epithelium, adjacent to the location of choroidal neovascularization at baseline Number in each group unknown or missing: 12, 8, 16, 18;
Number in each group unknown or missing: 16, 12, 22, 27;
Comparison restricted to as-needed groups
Areas of hypopigmentation or hyperfluorescence of ≥250μ diameter having ≥2 of the following characteristics: circular shape, sharp borders, visible choroidal vessels. Areas meeting this definition surrounding a scar were not considered geographic atrophy. Excluded those with geographic atrophy at enrollment: 6 (4.4%), 6 (4.7%), 20 (7.8%), 18 (7.2%)