Table 1 Baseline characteristics and intergroup differences at the time of allocation (per protocol set).
Characteristics | TK-98 (44 patients, 87 eyes) | Placebo (25 patients, 46 eyes) | Intergroup difference | Intergroup comparison P Value | Annual change in the placebo group31 |
---|---|---|---|---|---|
Age, year | 51.0 ± 11.3 | 52.1 ± 14.4 | − 1.1 | 0.628 | |
Sex, n, female/male, (female %) | 23/21 (52.3%) | 14/11 (56.0%) | 0.462 | ||
MD value at the time of allocation (10-2) (dB) | − 14.8 ± 4.9 | − 14.2 ± 5.1 | − 0.6# | 0.549 | − 0.52 |
MD slope just before the allocation (dB/year)* | − 0.11 ± 0.92 | − 0.42 ± 0.89 | 0.31 | 0.071 | |
Total point score (10-2) (dB) | 1229.2 ± 329.6 | 1257.1 ± 361.3 | − 27.9 | 0.659 | − 35.4 |
Total point score (30-2) (dB) | 482.4 ± 350.7 | 469.5 ± 309.1 | 12.9 | 0.838 | − 21.9 |
Ellipsoid zone length (µm) | 1557.4 ± 1362.3 | 2045.5 ± 1287.8 | − 488.1# | 0.051 | − 95.6 |
Time from onset of first subjective symptoms (year) | 28.5 ± 13.1 | 26.9 ± 12.9 | 1.6 | 0.510 | |
Lens, n, Phakia/Pseudophakia, (Phakia %) | 75/12 (86.2%) | 29/17 (63.0%) | − 1.1 | 0.002 |