Table 4.
Safety outcomes following intravitreal aflibercept treatment for 24 months
| Safety event, n (%) | Treatment-naïve (n = 1480) | Previously treated (n = 386) |
|---|---|---|
| Any TEAE | 291 (19.7) | 12 (3.1) |
| Oculara | 194 (13.1) | 5 (1.3) |
| Any TEAE (treatment-related) | 29 (2.0)b | 3 (0.8)c |
| Oculara | 21 (1.4) | 0 |
| Discontinuation due to TEAE | 3 (0.2) | 0 |
| Discontinuation due to treatment-related TEAE | 1 (0.1) | 0 |
| Any serious TEAE | 71 (4.8)d | 5 (1.3)e |
| Oculara | 7 (0.5) | 0 |
| All serious ocular TEAEsa | 7 (0.5) | 0f |
| Retinal detachment | 2 (0.1) | 0 |
| Cataract | 1 (0.1) | 0 |
| Eye hemorrhage | 1 (0.1) | 0 |
| Tractional retinal detachment | 1 (0.1) | 0 |
| Uveitis | 1 (0.1) | 0 |
| Vitreous hemorrhage | 1 (0.1) | 0 |
TEAE, treatment-emergent adverse event
aTEAEs listed under the “eye disorders” category in MedDRA
bSeven cases of conjunctival hemorrhage and four cases of intraocular pressure increased; all other TEAEs deemed study drug-related by the investigator occurred ≤ 3 times
cOne case of endophthalmitis and two cases of transient ischemic attack were deemed study drug-related by the investigator
dThe most common serious TEAEs were cerebrovascular accident (n = 6, 0.4%) and myocardial infarction (n = 4, 0.3%). All other serious TEAEs occurred ≤ 3 times
eOne case each of endophthalmitis, femur fracture, and diabetic complication, and two cases of transient ischemic attack
fThe case of endophthalmitis was listed under the “infections and infestations” category in MedDRA