Table 1. Patient demographic, and baseline ophthalmic and lesion criteria, for 48 patients included in the efficacy evaluations.
Parameter | Results | ||
---|---|---|---|
Demographic characteristics | |||
Mean age, years (SD) | 56.8 (14.39) | ||
Age distribution, n (%) | |||
<50 years | 14 (29.2) | ||
50 to <65 years | 22 (45.8) | ||
65 to <75 years | 9 (18.8) | ||
75+ years | 3 (6.3) | ||
Gender, n (%) | |||
Female | 35 (72.9) | ||
Male | 13 (27.1) | ||
Ethnic origin, n (%) | |||
Caucasian | 44 (91.7) | ||
Other | 4 (8.3) | ||
Mean weight, kg | 78.14 | ||
Mean PM duration, years (SD) | 40.45 (21.42) | ||
Median PM duration, years | 46.86 | ||
Mean CNV duration, months (SD) | 1.8 (3.36) | ||
Median CNV duration, months | 0.6 | ||
Baseline ophthalmic characteristics | |||
Mean VA letters (SD) | 58.6 (14.63) | ||
Median visual VA letters | 61 | ||
Patients, n (%) | |||
<23 Letters | 1 (2.1) | ||
23–37 Letters | 4 (8.3) | ||
38–52 Letters | 9 (18.8) | ||
53–67 Letters | 20 (41.7) | ||
68–82 Letters | 13 (27.1) | ||
>82 Letters | 1 (2.1) | ||
Mean CMT, μm (SD) | 365.5 (111.60) | ||
Median CMT, μm | 375.0 | ||
Study eye worse than fellow eye (%) | 72.9 | ||
Baseline lesion criteria (clinician reported) | |||
Criteria | No | Yes | Questionable |
Intraretinal oedema with centre involvement, n (%) | 4 (8.3) | 44 (91.7) | NA |
Intraretinal cysts, n (%) | 12 (25.0) | 28 (58.3) | 8 (16.7) |
Subretinal fluid, n (%) | 11 (22.9) | 31 (64.6) | 6 (12.5) |
Subretinal/intraretinal haemorrhage, n (%) | 18 (37.5) | 29 (60.4) | 1 (2.1) |
CNV location, n (%) | |||
N/A | 1 (2.1) | ||
Subfoveal | 32 (66.7) | ||
Juxtafoveal | 11 (22.9) | ||
Probably subfoveal/juxtafoveal | 4 (8.3) | ||
Mean area of lesion, mm2 (SD) | 1.459 (1.392) | ||
Median area of lesion, mm2 | 1.080 |
Abbreviations: CMT, central macular thickness; CNV, choroidal neovascularisation; N/A, not available; PM, pathological myopia; SD, standard deviation; VA, visual acuity.
Baseline lesion criteria data are derived from the full safety data set.