Table 1. Baseline Demographics and Disease Characteristics (Full Analysis Set).
Characteristic | IAI Plus Sham PDT (n = 157) |
IAI Plus Active PDT (n = 161) |
---|---|---|
Sex, No. (%) | ||
Male | 110 (70.1) | 112 (69.6) |
Female | 47 (29.9) | 49 (30.4) |
Race, No. (%) | ||
Asian | 145 (92.4) | 151 (93.8) |
Non-Asian | 12 (7.6) | 10 (6.2) |
Ethnicity, country, No. (%) | ||
Japanese | 75 (47.8) | 77 (47.8) |
Non-Japanese | 82 (52.2) | 84 (52.2) |
Age, mean (SD), y | 70.8 (8.4) | 70.4 (8.0) |
Disease duration, median, mo | 0.49a | 0.39 |
Baseline BCVA score, mean (SD) | 57.7 (11.3) | 59.0 (11.5) |
Total NEI VFQ-25 score at baseline, mean (SD) | 79.0 (11.5) | 75.4 (14.6) |
Mean CST at baseline, mean (SD) | 347.8b (118.9) | 346.1c (117.5) |
Type of CNV lesions at screening, No. (%) | ||
CNV < 50% of lesion | 22 (14.0) | 19 (11.8) |
CNV > 50% of lesion | ||
Predominantly classic | 23 (14.6) | 13 (8.1) |
Minimally classic/occult | 112 (71.3) | 129 (80.1) |
Total lesion size at baseline, mean (SD), mm2 | 8.13 (7.89) | 7.91 (6.67) |
CNV size at baseline, mean (SD), mm2 | 6.06 (6.28) | 5.86 (5.06)d |
Presence of polypoidal lesions, detected with ICGA, No. (%) | 139 (88.5) | 143 (88.8) |
Presence of branch vessel network, No. (%) | 122 (77.7) | 138 (85.7) |
Presence of serous/hemorrhagic PED, No. (%) | 78 (49.7) | 70 (43.8) |
Smoking history, No. (%) | ||
Never | 64 (40.8) | 73 (45.3) |
Former | 67 (42.7) | 65 (40.4) |
Current | 26 (16.6) | 23 (14.3) |
Qualified for rescue therapy at week 12, No. (%) | ||
Rescue therapy | 8 (5.1) | 11 (6.8) |
Nonrescue therapy | 149 (94.9) | 150 (93.2) |
Abbreviations: BCVA, best-corrected visual acuity; CNV, choroidal neovascularization; CRT, central retinal thickness; CST, central subfield thickness; IAI, intravitreal aflibercept injection; ICGA, indocyanine green angiography; NEI VFQ-25, 25-item National Eye Institute Visual Function Questionnaire; PDT, photodynamic therapy; PED, pigment epithelial detachment.
n = 156.
n = 152.
n = 158.
n = 160.