Table 1.
Baseline demographic and ocular characteristics, intent-to-treat population
| Asian country subgroup (n = 120) | Non-Asian country subgroup (n = 1209) | |||
|---|---|---|---|---|
| Faricimab 6 mg (n = 61) |
Aflibercept 2 mg (n = 59) |
Faricimab 6 mg (n = 604) |
Aflibercept 2 mg (n = 605) |
|
| Age (years), mean ± SDa | 71.1 ± 8.6 | 70.7 ± 9.0 | 75.8 ± 8.4 | 77.0 ± 8.5 |
| Sex, n (%) | ||||
| Female | 15 (24.6%) | 19 (32.2%) | 379 (62.7%) | 380 (62.8%) |
| Male | 46 (75.4%) | 40 (67.8%) | 225 (37.3%) | 225 (37.2%) |
| Ethnicity or race, n (%)b | ||||
| Hispanic or Latino | 0 | 1 (1.7%) | 61 (10.1%) | 71 (11.7%) |
| White | 0 | 0 | 581 (96.2%) | 572 (94.5%) |
| American Indian or Alaska Native | 0 | 0 | 2 (0.3%) | 2 (0.3%) |
| Black or African American | 0 | 0 | 2 (0.3%) | 8 (1.3%) |
| Asianc | 61 (100%) | 59 (100%) | 3 (0.5%) | 3 (0.5%) |
| Japanese | 26 (42.6%) | 26 (44.1%) | 0 | 1 (33.3%) |
| Korean | 16 (26.2%) | 19 (32.2%) | 1 (33.3%) | 0 |
| Taiwanese | 11 (18.0%) | 8 (13.6%) | 0 | 0 |
| Chinese | 8 (13.1%) | 6 (10.2%) | 0 | 0 |
| Other Asian | 0 | 0 | 1 (33.3%) | 2 (66.7%) |
| Asian Indian | 0 | 0 | 1 (33.3%) | 0 |
| Region, n (%) | ||||
| US and Canada | 0 | 0 | 317 (52.5%) | 316 (52.2%) |
| Rest of the worldd | 0 | 0 | 287 (47.5%) | 289 (47.8%) |
| Asiae | 61 (100%) | 59 (100%) | 0 | 0 |
| Smoking status, n (%) | ||||
| Never smoked | 22 (36.1%) | 23 (39.0%) | 291 (48.2%) | 309 (51.1%) |
| Previous smoker | 25 (41.0%) | 21 (35.6%) | 226 (37.4%) | 215 (35.5%) |
| Current smoker | 14 (23.0%) | 15 (25.4%) | 87 (14.4%) | 81 (13.4%) |
| BMI, mean ± SD | 24.4 ± 3.6 | 24.1 ± 3.1 | 28.1 ± 5.7 | 28.3 ± 5.7 |
| BCVA (ETDRS letters), mean ± SD | 59.9 ± 13.6 | 59.3 ± 13.6 | 60.0 ± 13.3 | 60.3 ± 13.1 |
| BCVA categories, n (%) | ||||
| ≥ 74 (20/32 or better) | 8 (13.1%) | 6 (10.2%) | 84 (13.9%) | 85 (14.0%) |
| 73–55 (between 20/40 and 20/80) | 32 (52.5%) | 34 (57.6%) | 349 (57.8%) | 350 (57.9%) |
| ≤ 54 (20/80 or worse) | 21 (34.4%) | 19 (32.2%) | 171 (28.3%) | 170 (28.1%) |
| CST (ILM-RPE) (µm), mean ± SD | 336.5 ± 133.1 | 334.3 ± 104.2 | 358.8 ± 120.8 | 359.8 ± 120.6 |
| Intraocular pressure (mm Hg), mean ± SD | 14.1 ± 3.2 | 14.1 ± 2.9 | 15.1 ± 2.9 | 14.9 ± 3.0 |
| Time since AMD diagnosis, n (%) | ||||
| ≤ 1 month | 35 (57%) | 34 (58%) | 434 (72%) | 420 (69%) |
| > 1 month | 22 (36%) | 22 (37%) | 140 (23%) | 162 (27%) |
| Phakic, n (%) | 45 (73.8%) | 48 (81.4%) | 338 (56.0%) | 321 (53.1%) |
| Presence of IRF, n (%) | 19 (31.1%) | 17 (28.8%) | 269 (44.5%) | 294 (48.6%) |
| Presence of SRF, n (%) | 45 (73.8%) | 47 (79.7%) | 392 (64.9%) | 400 (66.1%) |
| CNV location by FFA, n (%) | ||||
| Subfoveal | 35 (57.4%) | 28 (47.5%) | 375 (62.1%) | 349 (57.7%) |
| Juxtafoveal | 14 (23.0%) | 19 (32.2%) | 147 (24.3%) | 153 (25.3%) |
| Extrafoveal | 11 (18.0%) | 11 (18.6%) | 72 (11.9%) | 88 (14.5%) |
| CNV lesion type by FFA, n (%) | ||||
| Classic/predominantly classic | 12 (19.7%) | 15 (25.4%) | 193 (32.0%) | 202 (33.4%) |
| Occult/minimally classic/PCV | 43 (70.5%) | 37 (62.7%) | 378 (62.6%) | 352 (58.2%) |
| RAP | 5 (8.2%) | 6 (10.2%) | 23 (3.8%) | 36 (6.0%) |
| Missing | 1 (1.6%) | 1 (1.7%) | 10 (1.7%) | 15 (2.5%) |
| Total area of CNV lesion by FFA (mm2), mean ± SD | 3.8 ± 4.0 | 4.4 ± 4.6 | 4.8 ± 4.8 | 4.4 ± 4.2 |
| PCV status per ICGA, n (%)f | 8 (18.6%) | 8 (22.9%) | 0 | 0 |
aAge at randomization
bNot all race categories are listed; therefore, the sum of proportions shown may not equal 100%
cPercentages for Asian race subgroups are based on the number of Asian patients in each treatment group
dNon-Asian includes all subjects from Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Denmark, France, Germany, Hungary, Israel, Italy, Mexico, the Netherlands, Poland, Portugal, Russia, Spain, Switzerland, Turkey, United Kingdom, and United States
eAsia includes Hong Kong, Japan, Singapore, South Korea, and Taiwan
fFor the Asian country subgroup: faricimab n = 43 and aflibercept n = 35; for the non-Asian country subgroup: faricimab n = 124; aflibercept n = 109
AMD age-related macular degeneration, BCVA best-corrected visual acuity, BMI body mass index, CNV choroidal neovascularization, CST central subfield thickness, ETDRS Early Treatment Diabetic Retinopathy Study, FFA fundus fluorescein angiography, ICGA indocyanine green angiography, ILM internal limiting membrane, IRF intraretinal fluid, PCV polypoidal choroidal vasculopathy, RAP retinal angiomatous proliferation, RPE retinal pigment epithelium, SD standard deviation, SRF subretinal fluid