Table 3. Safety Overview at Week 52.
| Characteristic | IAI Plus Sham PDT (n = 157) |
IAI Plus Active PDT (n = 161) |
Treated But Not Randomizeda (n = 15) |
|---|---|---|---|
| Study participants with AEs, No. (%) | |||
| Any AE | 102 (65.0) | 86 (53.4) | 6 (40.0) |
| Any pretreatment AE | 16 (10.2) | 11 (6.8) | 1 (6.7) |
| Any posttreatment AE | 9 (5.7) | 4 (2.5) | 0 |
| Any TEAE | 96 (61.1) | 83 (51.6) | 6 (40.0) |
| Any ocular TEAE | 49 (31.2) | 47 (29.2) | 3 (20.0) |
| Study eye | 43 (27.4) | 34 (21.1) | 3 (20.0) |
| Fellow eye | 23 (14.6) | 27 (16.8) | 0 |
| Any nonocular TEAE | 74 (47.1) | 64 (39.8) | 5 (33.3) |
| Any SAE | 17 (10.8) | 16 (9.9) | 4 (26.7) |
| Any ocular SAE | 0 | 5 (3.1) | 1 (6.7) |
| Study eye | 0 | 5 (3.1) | 1 (6.7) |
| Fellow eye | 0 | 0 | 0 |
| Any nonocular SAE | 17 (10.8) | 12 (7.5) | 3 (20.0) |
| Any AE leading to discontinuation of the study drug | 3 (1.9) | 3 (1.9) | 2 (13.3) |
| Any AE leading to interruption of the study drug | 3 (1.9) | 1 (0.6) | 0 |
| Any death | 1 (0.6) | 0 | 1 (6.7) |
| Any APTC-classified event | 1 (0.6) | 1 (0.6) | 1 (6.7) |
| Nonfatal stroke | |||
| Cerebral infarction | 0 | 1 (0.6) | 0 |
| Vascular death | |||
| Arrhythmia | 1 (0.6) | 0 | 0 |
| Sudden cardiac death | 0 | 0 | 1 (6.7) |
Abbreviations: AE, adverse event; APTC, Antiplatelet Trialists' Collaboration; IAI, intravitreal aflibercept injection; PDT, photodynamic therapy; SAE, serious AE; TEAE, treatment-emergent AE.
a
All study participants who were enrolled in the study and received treatment but were not randomized at week 12 because of protocol deviation, adverse event, withdrawal, death, or loss to follow-up.