Table 2.
Treatment-emergent adverse events during the first 6 months (safety population)a
| Adverse event preferred term, n (%)b | DEX (n = 129) | Sham (n = 130) |
|---|---|---|
| IOP increased | 38 (29.5) | 4 (3.1) |
| Conjunctival hemorrhage | 24 (18.6) | 5 (3.8) |
| Conjunctival hyperemia | 17 (13.2) | 6 (4.6) |
| Visual acuity reduced | 4 (3.1) | 6 (4.6) |
| Conjunctival edema | 4 (3.1) | 1 (0.8) |
| Ocular hypertension | 4 (3.1) | 0 (0) |
| Eye pain | 3 (2.3) | 3 (2.3) |
| Headache | 3 (2.3) | 1 (0.8) |
| Vitreous hemorrhage | 0 (0) | 3 (2.3) |
DEX dexamethasone intravitreal implant, IOP intraocular pressure
aAll treatment-emergent adverse events reported in >2% of patients in either treatment group are listed
bAdverse events were categorized for analysis using MedDRA version 17.0 preferred terms