Table 2. Best-Corrected Visual Acuity Letter Score and Change in BCVA From Baseline to Month 12 for the Full Analysis Set.
Parameter/Visita | Ranibizumab (n=141) | Aflibercept (n=137) |
---|---|---|
Baseline | ||
BCVA letter score (logMAR) [approximate Snellen equivalent] | ||
No. | 141 | 137 |
Mean (SD) | 65.3 (15.10) [20/50] | 65.1 (12.53) [20/50] |
Median (range) | 68.0 (23 to 90) [20/40] | 67.0 (23 to 89) [20/50] |
Stratification by BCVA letter score [approximate Snellen equivalent], No. (%) | ||
<39 [<20/160] | 8 ( 5.7) | 6 ( 4.4) |
39-54 [20/160 to <20/80] | 27 ( 19.1) | 19 ( 13.9) |
55-69 [20/80 to <20/40] | 38 ( 27.0) | 53 ( 38.7) |
70-84 [20/40 to <20/20] | 58 ( 41.1) | 56 ( 40.9) |
85-100 [≥20/20] | 10 ( 7.1) | 3 ( 2.2) |
Week 4 | ||
BCVA letter score (logMAR) [approximate Snellen equivalent] | ||
No. | 138 | 137 |
Mean (SD) | 67.8 (13.53) [20/40] | 65.3 (13.19) [20/50] |
Median (range) | 71.0 (34 to 94) [20/40] | 68.0 (22 to 88) [20/40] |
Stratification by BCVA letter score [approximate Snellen equivalent], No. (%) | ||
<39 [<20/160] | 5 ( 3.6) | 6 ( 4.4) |
39-54 [20/160 to <20/80] | 20 ( 14.5) | 25 ( 18.2) |
55-69 [20/80 to <20/40] | 40 ( 29.0) | 47 ( 34.3) |
70-84 [20/40 to <20/20] | 66 ( 47.8) | 54 ( 39.4) |
85-100 [≥20/20] | 7 ( 5.1) | 5 ( 3.6) |
Change in BCVA letter score from baselineb | ||
No. | 138 | 137 |
Mean (SD) | 2.5 (8.47) | 0.2 (8.55) |
Median (range) | 1.0 (−19 to 39) | 0.0 (−31 to 21) |
Stratification by change in BCVA letter score, No. (%) | ||
Gained ≥15 letters | 11 ( 8.0) | 5 ( 3.6) |
Gained 10-14 letters | 11 ( 8.0) | 10 ( 7.3) |
Gained 1-9 letters | 56 ( 40.6) | 52 ( 38.0) |
Lost 0-9 letters | 53 ( 38.4) | 60 ( 43.8) |
Lost 10-14 letters | 5 ( 3.6) | 3 ( 2.2) |
Lost ≥15 letters | 2 ( 1.4) | 7 ( 5.1) |
Week 8 | ||
BCVA letter score (logMAR) [approximate Snellen equivalent] | ||
No. | 137 | 137 |
Mean (SD) | 70.4 (15.31) [20/40] | 68.7 (13.46) [20/40] |
Median (range) | 76.0 (27 to 94) [20/32] | 72.0 (11 to 90) [20/40] |
Stratification by BCVA letter score [approximate Snellen equivalent], No. (%) | ||
<39 [<20/160] | 5 ( 3.6) | 4 ( 2.9) |
39-54 [20/160 to <20/80] | 19 ( 13.9) | 15 ( 10.9) |
55-69 [20/80 to <20/40] | 29 ( 21.2) | 41 ( 29.9) |
70-84 [20/40 to <20/20] | 64 ( 46.7) | 68 ( 49.6) |
85-100 [≥20/20] | 20 ( 14.6) | 9 ( 6.6) |
Change in BCVA letter score from baselineb | ||
No. | 137 | 137 |
Mean (SD) | 5.3 (9.07) | 3.6 (10.86) |
Median (Range) | 4.0 (−15 to 49) | 3.0 (−33 to 42) |
Stratification by change in BCVA letter score, No. (%) | ||
Gained ≥15 letters | 18 ( 13.1) | 18 ( 13.1) |
Gained 10-14 letters | 18 ( 13.1) | 21 ( 15.3) |
Gained 1-9 letters | 69 ( 50.4) | 48 ( 35.0) |
Lost 0-9 letters | 27 ( 19.7) | 40 ( 29.2) |
Lost 10-14 letters | 4 ( 2.9) | 2 ( 1.5) |
Lost ≥15 letters | 1 ( 0.7) | 8 ( 5.8) |
Month 12 | ||
BCVA letter score (logMAR) [approximate Snellen equivalent], No. (%) | ||
No. | 127 | 121 |
Mean (SD) | 72.9 (15.54) [20/32] | 70.5 (14.63) [20/40] |
Median (range) | 78.0 (5 to 95) [20/25] | 74.0 (36 to 91) [20/32] |
Stratification by BCVA letter score [approximate Snellen equivalent], No. (%) | ||
<39 [<20/160] | 4 ( 3.1) | 5 ( 4.1) |
39-54 [20/160 to <20/80] | 13 ( 10.2) | 13 ( 10.7) |
55-69 [20/80 to <20/40] | 22 ( 17.3) | 25 ( 20.7) |
70-84 [20/40 to <20/20] | 63 ( 49.6) | 58 ( 47.9) |
85-100 [≥20/20] | 25 ( 19.7) | 20 ( 16.5) |
Change in BCVA letter score from baselineb | ||
No. | 127 | 121 |
Mean (SD) | 6.9 (12.25) | 5.2 (12.83) |
Median (range) | 6.0 (−41 to 52) | 5.0 (−38 to 37) |
Stratification by change in BCVA letter score, No. (%) | ||
Gained ≥15 letters | 28 ( 22.0) | 25 ( 20.7) |
Gained 10-14 letters | 17 ( 13.4) | 20 ( 16.5) |
Gained 1-9 letters | 52 ( 40.9) | 34 ( 28.1) |
Lost 0-9 letters | 24 ( 18.9) | 28 ( 23.1) |
Lost 10-14 letters | 2 ( 1.6) | 8 ( 6.6) |
Lost ≥15 letters | 4 ( 3.1) | 6 ( 5.0) |
Abbreviation: BCVA, best-corrected visual acuity.
Mandatory visit times are included for the analysis: baseline, week 4, week 8, and month 12.
The last available nonmissing value collected before the start of treatment in the study eye. One participant in the aflibercept arm had baseline BCVA assessed using a Snellen chart instead of a logMAR chart. The BCVA total score for that participant was converted from Snellen to logMAR.