Summary of 1-year incidence of targeted ocular events
| Number of ocular events of particular interest (%) | WAVE Germany N=3470 | HELIOS Netherlands N=243 | HELIOS Belgium N=260 | Sweden N=471 | Total n=4444 |
|---|---|---|---|---|---|
| Any ocular event of particular interest | 73 (1.64) | ||||
| Retinal pigment epithelial tear | 16 (0.46) | 7 (2.88) | 3 (1.15) | 1 (0.21) | 27 (0.61) |
| Intraocular pressure-related events | 9 (0.26) | 2 (0.82) | 1 (0.38) | 0 | 12 (0.27) |
| Traumatic cataract | 5 (0.14) | 4 (1.65) | 1 (0.38) | 0 | 10 (0.23) |
| Vitreous haemorrhage | 7 (0.20) | 1 (0.41) | 0 | 0 | 8 (0.18) |
| Deterioration of retinal blood flow | 3 (0.09) | 2 (0.82) | 1 (0.38) | 0 | 6 (0.14) |
| Endophthalmitis | 4 (0.12) | 0 | 1 (0.38) | 0 | 5 (0.11) |
| Intraocular inflammation | 1 (0.03) | 1 (0.41) | 1 (0.38) | 0 | 3 (0.07) |
| Retinal tear | 1 (0.03) | 0 | 0 | 0 | 1 (0.02) |
| Retinal detachment | 0 | 0 | 1 (0.38) | 0 | 1 (0.02) |
The incidence rates for events of special interest were derived by summing the incidence rates of the relevant preferred terms. With this approach, patients might be counted more than once, which could have led to a conservative overestimation of the rate. Ocular safety events were recorded for both eyes in patients from HELIOS Netherlands and HELIOS Belgium; ocular safety events were recorded for the study eye only in patients from the German WAVE and Swedish registries.
HELIOS, Health Economics with Lucentis In Observational Settings; WAVE, Lucentis in Wet AMD: Evaluation of Visual Acuity and Quality of Life.