Table 1.
Baseline demographic and ocular characteristics in the TENAYA Japan subgroup and pooled global TENAYA/LUCERNE trials
| TENAYA Japan | Pooled global TENAYA/LUCERNE | |||
|---|---|---|---|---|
|
Faricimab
up to Q16W (n = 66) |
Aflibercept
Q8W (n = 67) |
Faricimab
up to Q16W (n = 665) |
Aflibercept
Q8W (n = 664) |
|
| Age, years, mean (SD) | 72.1 (7.5) | 71.8 (9.5) | 75.4 (8.5) | 76.4 (8.7) |
| Sex: Female, n (%) | 12 (18.2%) | 22 (32.8%) | 394 (59.2%) | 399 (60.1%) |
| Region, n (%) | ||||
| USA and Canada | 0 | 0 | 317 (47.7%) | 316 (47.6%) |
| Rest of the world | 0 | 0 | 287 (43.2%) | 289 (43.5%) |
| Asia | 66 (100%) | 67 (100%) | 61 (9.2%) | 59 (8.9%) |
| Race, n (%) | ||||
| White | 0 | 0 | 581 (87.4%) | 572 (86.1%) |
| Asian | 66 (100%) | 67 (100%) | 64 (9.6%) | 62 (9.3%) |
| American Indian or Alaska Native | 0 | 0 | 2 (0.3%) | 2 (0.3%) |
| Black or African American | 0 | 0 | 2 (0.3%) | 8 (1.2%) |
| Ethnicity, n (%) | ||||
| Hispanic or Latino | 0 | 0 | 61 (9.2%) | 72 (10.8%) |
| BCVA, ETDRS letters, mean (SD) | 59.1 (13.1) | 59.9 (13.2) | 60.0 (13.3) | 60.2 (13.1) |
| BCVA categories, n (%) | ||||
| ≥ 74 (20/32 or better) | 7 (10.6%) | 8 (11.9%) | 92 (13.8%) | 91 (13.7%) |
| 73–55 (between 20/80–20/40) | 38 (57.6%) | 38 (56.7%) | 381 (57.3%) | 384 (57.8%) |
| ≤ 54 (20/80 or worse) | 21 (31.8%) | 21 (31.3%) | 192 (28.9%) | 189 (28.5%) |
| CST (ILM-RPE), µm, mean (SD) | 354.1 (133.6) | 335.8 (142.6) | 356.8 (122.1) | 357.5 (119.4) |
| Presence of IRF, n (%) | 24 (36.4%) | 19 (28.4%) | 288 (43.3%) | 311 (46.8%) |
| Presence of SRF, n (%) | 51 (77.3%) | 50 (74.6%) | 437 (65.7%) | 447 (67.3%) |
| CNV location by FFA, n (%) | ||||
| Subfoveal | 36 (54.5%) | 30 (44.8%) | 410 (61.7%) | 377 (56.8%) |
| Juxtafoveal | 16 (24.2%) | 22 (32.8%) | 161 (24.2%) | 172 (25.9%) |
| Extrafoveal | 13 (19.7%) | 15 (22.4%) | 83 (12.5%) | 99 (14.9%) |
| Missing/Not Done | 1 (1.5%) | 0 | 11 (1.7%) | 16 (2.4%) |
| CNV lesion type by FFA, n (%) | ||||
| Predominantly classica | 13 (19.7%) | 10 (14.9%) | 205 (30.8%) | 217 (32.7%) |
| Minimally classic | 3 (4.5%) | 3 (4.5%) | 62 (9.3%) | 61 (9.2%) |
| Occult/ | 25 (37.9%) | 36 (53.7%) | 348 (52.3%) | 314 (47.3%) |
| Missing/Not done/Otherb | 25 (37.9%) | 18 (26.9%) | 50 (7.5%) | 72 (10.8%) |
| Total Area of CNV lesion by FFA, mm2, mean (SD) | 4.3 (4.4) | 5.6 (6.7) | 4.7 (4.8) | 4.4 (4.2) |
| PCV status per ICGA, n (%)c | 15 (31.3%) | 7 (18.9%) | 8 (4.8%) | 8 (5.6%) |
aIncludes classic CNV lesion types; bOther includes PCV and RAP; cFor the TENAYA Japan subgroup: faricimab, n = 48; aflibercept, n = 37; for the pooled global TENAYA/LUCERNE trials: faricimab, n = 167; aflibercept, n = 144
BCVA best-corrected visual acuity, 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, Q8W every 8 weeks, Q16W every 16 weeks, RAP retinal angiomatous proliferation, RPE retinal pigment epithelium, SD standard deviation, SRF subretinal fluid