Safety outcomes at 12 months
| AE, n (%) | SAS (n=593) | Regular cohort (n=102) | Irregular cohort with treatment initiation (n=266) | Irregular cohort without treatment initiation (n=60) |
| Any AE | 170 (28.7) | 22 (21.6) | 77 (28.9) | 12 (20.0) |
| Ocular | 87 (14.7) | 15 (14.7) | 48 (18.0) | 4 (6.7) |
| Non-ocular | 103 (17.4) | 11 (10.8) | 42 (15.8) | 8 (13.3) |
| Any treatment-related AE | 31 (5.2) | 5 (4.9) | 17 (6.4) | 1 (1.7) |
| Ocular | 27 (4.6) | 4 (3.9) | 16 (6.0) | 1 (1.7) |
| Non-ocular | 4 (0.7) | 1 (1.0) | 1 (0.4) | 0 |
| Most common (>1%) treatment-related ocular AEs occurring in any treatment group* | ||||
| Vitreous floaters | 11 (1.9) | 3 (2.9) | 6 (2.3) | – |
| Drug ineffective | 8 (1.3) | 1 (1.0) | 5 (1.9) | – |
| Eye pain | 7 (1.2) | – | 4 (1.5) | 1 (1.7) |
| Lacrimation increased | 7 (1.2) | 2 (2.0) | 5 (1.9) | – |
| Metamorphopsia | 6 (1.0) | 1 (1.0) | 3 (1.1) | – |
| Visual acuity reduced | 5 (0.8) | 1 (1.0) | 3 (1.1) | – |
| Vision blurred | 5 (0.8) | 1 (1.0) | 3 (1.1) | – |
| Eye allergy | 5 (0.8) | 1 (1.0) | – | 1 (1.7) |
| Injection-site pain | 4 (0.7) | – | 3 (1.1) | – |
| Photophobia | – | – | 3 (1.1) | – |
| Choroidal neovascularisation | – | – | – | 1 (1.7) |
| Retinal oedema | – | – | – | 1 (1.7) |
| Retinal vein occlusion | – | – | – | 1 (1.7) |
| Any treatment-emergent SAE | 46 (7.8) | 7 (6.9) | 18 (6.8) | 4 (6.7) |
| Ocular | 4 (0.7) | 2 (2.0) | 2 (0.8) | 0 |
| Non-ocular | 42 (7.1) | 5 (4.9) | 16 (6.0) | 4 (6.7) |
| Treatment-related ocular SAE | ||||
| Traumatic cataract | 1 (0.2) | 1 (1.0) | – | – |
| Treatment-related non-ocular SAE | ||||
| Transient ischaemic attack | 4 (0.7) | – | 3 (1.1) | – |
| Peripheral arterial occlusive disease | 1 (0.2) | – | – | – |
| Any AE leading to discontinuation | 31 (5.2) | 4 (3.9) | 17 (6.4) | 1 (1.7) |
| Ocular | 20 (3.4) | 2 (2.0) | 12 (4.5) | 1 (1.7) |
| Non-ocular | 13 (2.2) | 2 (2.0) | 7 (2.6) | 0 |
| Any treatment-related AE leading to discontinuation | 14 (2.4) | 1 (1.0) | 8 (3.0) | 1 (1.7) |
| Ocular | 14 (2.4) | 1 (1.0) | 8 (3.0) | 1 (1.7) |
| Non-ocular | 0 (0.0) | 0 | 0 | 0 |
| Death (not treatment-related) | 4 (0.7) | 0 | 0 | 0 |
Values in the cohort columns are based on the FAS population.
*AE rates<0.5% are not shown.
AE, adverse event; FAS, full analysis set; SAE, serious adverse event; SAS, safety analysis set.