Table 2.
Safety overview at week 5 (SAS)
| IVT-AFL N = 16 |
|
|---|---|
| Any TEAE | 6 (37.5) |
| Any IVT-AFL- or IVT procedure-related AE | 3 (18.8) |
| Any IVT-AFL-related AEa | 1 (6.3) |
| Any IVT procedure-related AEb | 2 (12.5) |
| Any protocol-required procedure-related AE | 0 |
| Ocular TEAEs ≥ 2 patients | |
| Eye pain | 4 (25.0) |
| Maximum intensity of any AE | |
| Mild | 4 (25.0) |
| Moderate | 2 (12.5) |
| Severe | 0 |
| Any SAEc | 1 (6.3) |
| Any IVT-AFL-related or IVT procedure-related SAE | 0 |
| Any IVT-AFL-related AE | 0 |
| Discontinuation of study drug because of an AE | 0 |
| Any death | 0 |
Values are number of patients (%)
AE adverse event, IVT-AFL intravitreal aflibercept, IVT intravitreal, SAE serious adverse event, SAS safety analysis set, TEAE treatment-emergent adverse event
aIVT-AFL-related AE was headache
bIVT procedure-related AEs were eye pain (n = 2; 12.5%) and eye pruritus (n = 1; 6.3%)
cSAE was pneumonia and was not considered related to treatment or injection procedure