Table 4.
Randomized Treatment Assignment | Disease Type | Anti-VEGF Treatment Prior to SCORE2 | Total | ||||
---|---|---|---|---|---|---|---|
Characteristic2 | Aflibercept | Bevacizumab | CRVO | HRVO | No | Yes | |
Number of participants | 180 | 182 | 307 | 55 | 241 | 121 | 362 |
Demographic Characteristics | |||||||
Age (years) – mean (SD) | 69(11) | 69(13) | 69(12) | 70(13) | 68(12) | 71(11) | 69(12) |
< 50 (%) | 7(3.9) | 15(8.2) | 18(5.9) | 4(7.3) | 18(7.5) | 4(3.3) | 22(6.1) |
50-<60 (%) | 28(15.6) | 26(14.3) | 48(15.6) | 6(10.9) | 38(15.8) | 16(13.2) | 54(14.9) |
60-<70 (%) | 59(32.8) | 48(26.4) | 95(30.9) | 12(21.8) | 74(30.7) | 33(27.3) | 107(29.6) |
70-<80 (%) | 58(32.2) | 52(28.6) | 92(30.0) | 18(32.7) | 65(27.0) | 45(37.2) | 110(30.4) |
≥ 80 (%) | 28(15.6) | 41(22.5) | 54(17.6) | 15(27.3) | 46(19.1) | 23(19.0) | 69(19.1) |
Women (%) | 82(45.6) | 75(41.2) | 136(44.3) | 21(38.2) | 96(39.8) | 61(50.4) | 157(43.4) |
White (%) | 131(72.8) | 145(79.7) | 246(80.1) | 30(54.5) | 186(77.2) | 90(74.4) | 276(76.2) |
Black (%) | 28(15.6) | 26(14.3) | 33(10.7) | 21(38.2) | 35(14.5) | 19(15.7) | 54(14.9) |
Other (%) | 21(11.7) | 11(6.0) | 28(9.1) | 4(7.3) | 20(8.3) | 12(9.9) | 32(8.8) |
Not Hispanic or Latino (%) | 164(91.1) | 160(87.9) | 274(89.3) | 50(90.9) | 214(88.8) | 110(90.9) | 324(89.5) |
Study Eye Characteristics | |||||||
E-ETDRS visual acuity letter score – mean (SD) | 50(15) | 50(15) | 50(15) | 54(14) | 50(15) | 50(15) | 50(15) |
59–73 (20/40 to 20/63) (%) | 66(36.7) | 67(36.8) | 108(35.2) | 25(45.5) | 88(36.5) | 45(37.2) | 133(36.7) |
49–58 (20/80 to 20/100) (%) | 43(23.9) | 42(23.1) | 70(22.8) | 15(27.3) | 58(24.1) | 27(22.3) | 85(23.5) |
19–48 (20/125 to 20/400) (%) | 71(39.4) | 73(40.1) | 129(42.0) | 15(27.3) | 95(39.4) | 49(40.5) | 144(39.8) |
Duration of macular edema (months) – mean (SD) | 8(17) | 5(10) | 7(14) | 3(10) | 1(3) | 18(19) | 6(14) |
Missing | 1(0.6) | 1(0.5) | 2(0.7) | 0(0.0) | 0(0.0) | 2(1.7) | 2(0.6) |
<3 (%) | 114(63.3) | 129(70.9) | 199(64.8) | 44(80.0) | 230(95.4) | 13(10.7) | 243(67.1) |
3 – 6 (%) | 18(10.0) | 11(6.0) | 25(8.1) | 4(7.3) | 8(3.3) | 21(17.4) | 29(8.0) |
7 – 12 (%) | 17(9.4) | 17(9.3) | 30(9.8) | 4(7.3) | 2(0.8) | 32(26.4) | 34(9.4) |
>12 (%) | 30(16.7) | 24(13.2) | 51(16.6) | 3(5.5) | 1(0.4) | 53(43.8) | 54(14.9) |
OCT central subfield (microns) – mean (SD) | 665(220) | 690(238) | 691(230) | 606(213) | 689(229) | 655(231) | 678(230) |
Prior anti-VEGF treatment | 65(36.1) | 56(30.8) | 108(35.2) | 13(23.6) | - | 121(100) | 121(33.4) |
HRVO | 24(13.3) | 31(17.0) | - | 55(100) | 42(17.4) | 13(10.7) | 55(15.2) |
Lens Status | |||||||
Cataract extraction | 43(23.9) | 55(30.2) | 83(27.0) | 15(27.3) | 57(23.7) | 41(33.9) | 98(27.1) |
Natural lens, history of cataract | 108(60.0) | 95(52.2) | 170(55.4) | 33(60.0) | 137(56.8) | 66(54.5) | 203(56.1) |
Natural lens, no history of cataract | 29(16.1) | 32(17.6) | 54(17.6) | 7(12.7) | 47(19.5) | 14(11.6) | 61(16.9) |
Other Clinical Characteristics | |||||||
Diabetes mellitus (%) | |||||||
Type 1 | 1(0.6) | 0(0.0) | 1(0.3) | 0(0.0) | 0(0.0) | 1(0.8) | 1(0.3) |
Type 2 | 54(30.0) | 59(32.4) | 95(30.9) | 18(32.7) | 74(30.7) | 39(32.2) | 113(31.2) |
Hypertensive (%) | 140(77.8) | 138(75.8) | 236(76.9) | 42(76.4) | 184(76.3) | 94(77.7) | 278(76.8) |
Coronary artery disease (%) | 26(14.4) | 29(15.9) | 48(15.6) | 7(12.7) | 34(14.1) | 21(17.4) | 55(15.2) |
NEI-VFQ-25 overall score | 77(15) | 77(17) | 77(16) | 78(16) | 76(16) | 78(16) | 77(16) |
P-values that are less than 0.05, either before adjustment (comparing treatment groups), or after adjustment (comparing CRVO vs HRVO, or prior versus no prior anti VEGF) are highlighted
Mean (Std Dev) unless otherwise noted