Country | WAVE Germany N=3470 | HELIOS Netherlands N=243 | HELIOS Belgium N=253 | Sweden N=471 |
---|---|---|---|---|
Mean age, years (SD) | 77.6 (±7.8) | 77.9 (±8.0) | 78.7 (±6.8) | 78.1 (±8.0) |
Gender | ||||
Female | 64.6% | 59.3% | 62.1% | 66.0% |
Male | 35.3% | 40.7% | 37.9% | 34.0% |
No previous NV-AMD treatment | 75.1% | 83.5% | 75.9% | 42.3% |
Mean baseline VA ETDRS letters (SD)* | 48.8 (±18.7) | 45.1 (±21.5) | 56.3 (±14.2) | 58.3 (±12.2)† |
Patients in study at 1 year | n=2587 | n=208 | n=178 | n=370 |
Mean VA at 1 year ETDRS letters (SD)* | 48.0 (±11.7) | 50.7 (±24.0) | 58.8 (±17.9) | 59.3 (±16.2) |
Mean number of injections (SD)* | ||||
All patients | 4.0 (±1.8) | 5.1 (±2.4) | 5.0 (±2.1) | 4.4 (±1.6) |
Patients who completed 1 year | 4.3 (±1.9) | 5.5 (±2.3) | 5.7 (±1.8)‡ | 4.7 (±1.6) |
*Visual acuity and mean number of injections are for the primary study eye only.
†n=367 from patients having completed 1 year. Due to missing data and being based on observed data, the number of observations can be smaller than N.
‡N=203, based on 12 month completers from final study report (N=178 for interim analysis). LogMAR VA or Snellen VA fractions were measured and converted to Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores as described by Gregori NZ, et al.12 Formula of conversion from Snellen fraction to ETDRS letters: 85+50×log(Snellen fraction); formula of conversion from LogMAR to ETDRS letters: 85-50 LogMAR.
HELIOS, Health Economics with Lucentis in Observational Settings; NV-AMD, neovascular age-related macular degeneration; SD, standard deviation; VA, visual acuity; WAVE, Lucentis in Wet AMD: Evaluation of Visual Acuity and Quality of Life.