Table 4.
Most frequently reported adverse events in Phase III studies of dexamethasone intravitreal implant in the treatment of diabetic macular edema
| Adverse event | Incidence (% patients)
|
||
|---|---|---|---|
| DEX implant 0.35 mg | DEX implant 0.7 mg | Sham control | |
| Cataract relateda | 64.1 | 67.9 | 20.4 |
| IOP elevationb | 27.4 | 32.0 | 4.3 |
| Conjunctival hemorrhage | 25.9 | 21.0 | 12.9 |
| Vitreous hemorrhage | 13.1 | 6.9 | 7.1 |
| Macular fibrosis | 10.8 | 5.8 | 2.9 |
| Conjunctival hyperemia | 8.7 | 5.8 | 5.4 |
| Vitreous detachment | 6.7 | 4.9 | 2.3 |
| Retinal hemorrhage | 5.8 | 4.0 | 4.3 |
| Dry eye | 5.5 | 6.1 | 2.6 |
| Conjunctival edema | 5.0 | 4.3 | 1.1 |
| Conjunctivitis | 4.4 | 5.5 | 2.3 |
Notes:
a
Cataract, cataract cortical, cataract subcapsular, cataract nuclear, or lenticular opacities.
b
IOP ≥25 mmHg. Data from Boyer et al.82
Abbreviations: DEX implant, dexamethasone intravitreal implant; IOP, intraocular pressure.