Table 2 Outcomes at 3-months follow up
Outcome | Monotherapy arm (three monthly IVB) n = 32 | Combination arm (single dose of SCTA + three monthly IVB) n = 26 | Mean difference (combination – monotherapy) (95% CI) a | Linear mixed-effects model analysis (combination vs monotherapy) (95% CI) b |
|---|---|---|---|---|
Visual acuity (log MAR) | – | |||
Baseline c | 0.79 (0.29) | 0.80 (0.32) | 0.00 (− 0.15 to 0.17) P = 0.91 | – |
4 weeks c | 0.70 (0.27) | 0.59 (0.36) | – | – |
Change (4 weeks – baseline) d | - 0.09 (0.07) | - 0.20 (0.10) | - 0.11 (− 0.21 to - 0.01) P = 0.010 | – |
Within group analysis e | P = 0.22 | P = 0.046 | – | – |
12 weeks c | 0.59 (0.24) | 0.42 (0.30) | – | – |
Change (12 weeks – baseline) d | - 0.20 (0.07) | - 0.37 (0.09) | - 0.17 (− 0.38 to - 0.05) P = 0.004 | - 0.15 (− 0.27 to - 0.03) P = 0.014 |
Within group analysis e | P = 0.004 | P < 0.001 | – | |
Visual acuity (ETDRS Letter scores) | – | |||
Baseline | 46 (14) | 45 (16) | 0 (− 8 to 8) P = 0.91 | – |
4 weeks | 50 (13) | 55 (18) | – | – |
Change (4 weeks – baseline) | 4 (4) | 10 (5) | 6 (1 to 11) P = 0.010 | – |
Within group analysis | P = 0.22 | P = 0.046 | – | – |
12 weeks | 55 (12) | 64 (15) | – | – |
Change (12 weeks – baseline) | 10 (3) | 18 (4) | 9 (3 to 14) P = 0.005 | 7 (1 to 13) P = 0.018 |
Within group analysis | P = 0.004 | P < 0.001 | – | – |
No.(%) ≥ 15 ETDRS Letter scores improvement | 12 (37.5%) | 12 (46.2%) | P = 0.59 f | – |
Central subfield thickness (μm) | – | |||
Baseline | 520 (116) | 524 (153) | 4 (− 67 to 75) P = 0.91 | – |
4 weeks | 444 (117) | 337 (107) | – | – |
Change (4 weeks – baseline) | - 76 (31) | - 187 (42) | - 111 (− 270 to - 48) P = 0.010 | – |
Within group analysis | P = 0.015 | P < 0.001 | – | – |
12 weeks | 413 (109) | 348 (132) | – | – |
Change (12 weeks – baseline) | - 108 (28) | - 176 (37) | - 69 (− 131 to - 7) P = 0.038 | - 48 (− 89 to - 8) P = 0.019 |
Within group analysis | P < 0.001 | P < 0.001 | – | – |
No. below sex-specific normal threshold values (%) g | 8 (25%) | 14 (53.8%) | P = 0.032 f | – |
Macular volume (mm3) | – | |||
Baseline | 11.4 (1.8) | 11.3 (2.3) | - 0.1 (− 1.2 to 1) P = 0.83 | – |
4 weeks | 10.7 (1.5) | 9.6 (1.1) | – | – |
Change (4 weeks – baseline) | - 0.7 (0.4) | - 1.6 (0.6) | - 0.9 (− 2.1 to - 0.3) P = 0.027 | – |
Within group analysis | P = 0.11 | P = 0.007 | – | – |
12 weeks | 10.4 (1.5) | 9.9 (1.9) | – | – |
Change (12 weeks – baseline) | - 1.0 (0.4) | - 1.4 (0.5) | - 0.4 (−1.0 to 0.1) P = 0.19 | - 0.5 (− 1.0 to - 0.1) P = 0.027 |
Within group analysis | P = 0.020 | P = 0.011 | – | – |
Intraocular pressure (mmHg) | – | |||
Baseline | 14.9 (2.7) | 15.3 (3.2) | 0.4 (− 1.2 to 1.9) P = 0.65 | – |
4 weeks | 15.0 (1.9) | 16 (3.1) | – | – |
Change (4 weeks – baseline) | 0.1 (0.6) | 0.7 (0.9) | 0.6 (− 0.2 to 1.5) P = 0.18 | – |
Within group analysis | P = 0.93 | P = 0.42 | – | |
12 weeks | 15.5 (2.2) | 16.1 (2.6) | – | |
Change (12 weeks – baseline) | 0.6 (0.6) | 0.8 (0.8) | 0.2 (− 0.8 to 1.2) P = 0.65 | 0.6 (− 0.2 to 1.4) P = 0.13 |
Within group analysis | P = 0.28 | P = 0.31 | – | – |