Number of ranibizumab injections and laser treatments, number of visits scheduled for treatment from months 3 to 24 and treatment intervals up to month 24 (safety set)
| T&E ranibizumab 0.5 mg+laser n=126 | T&E ranibizumab 0.5 mg n=126 | PRN ranibizumab 0.5 mg n=118 | |
|---|---|---|---|
| Number of injections (up to month 24) | |||
| Total | 1563 | 1607 | 1259 |
| Mean±SD | 12.4±3.8 | 12.8±3.7 | 10.7±5.6 |
| Median (range) | 12 (3–23) | 12 (3–23) | 10 (1–24) |
| Frequency of injections, n (%) | |||
| 1–3 | 1 (0.8) | 1 (0.8) | 10 (8.47) |
| 4–6 | 6 (4.76) | 3 (2.38) | 20 (16.95) |
| 7–9 | 7 (5.56) | 7 (5.56) | 27 (22.88) |
| 10–12 | 66 (52.38) | 65 (51.59) | 22 (18.64) |
| 13–15 | 23 (18.25) | 23 (18.25) | 14 (11.86) |
| 16–18 | 12 (9.52) | 17 (13.49) | 12 (10.16) |
| 19–21 | 9 (7.14) | 8 (6.35) | 8 (6.78) |
| 22–24 | 2 (1.59) | 2 (1.59) | 5 (4.23) |
| Number of laser treatments (up to month 24) | |||
| Total | 146 | – | – |
| Mean±SD | 1.2±0.66 | – | – |
| Median (range) | 1 (0–4) | – | – |
| Frequency of laser, n (%) | |||
| 0 | 8 (6.3)* | – | – |
| 1 | 98 (77.8) | – | – |
| 2 | 15 (11.9) | – | – |
| 3 | 2 (1.6) | – | – |
| 4 | 3 (2.4) | – | – |
| Number of visits scheduled for treatment† after the visit with initial BCVA stability up to month 24 | |||
| Total‡ | 1131 | 1105 | 1828 |
| Mean±SD | 9.0±4.30 | 8.9±3.81 | 16.6±4.28 |
| Median (range) | 8 (1–21) | 8 (2–20) | 18 (1–20) |
| Average interval between treatment (months)§ | |||
| N | 123 | 123 | 90 |
| Mean±SD | 2.468±0.954 | 2.299±0.616 | 2.828±2.644 |
| Median (range) | 2.5 (0.93–7.95) | 2.4 (0.98–3.79) | 2.145 (0.68–19.63) |
| Frequency, n (%)¶ | |||
| 1 month (16–45 days) | 18 (14.6) | 20 (16.3) | 22 (24.4) |
| 2 months (46–75 days) | 44 (35.8) | 48 (39.0) | 36 (40.0) |
| 3 months (76–105 days) | 54 (43.9) | 54 (43.9) | 16 (17.8) |
| >3 months (≥106 days) | 7 (5.7) | 1 (0.8) | 16 (17.8) |
Safety set comprised all patients who received at least one active application of study treatment and had at least one postbaseline safety assessment.
Percentages are based on the number of patients in the safety set in the specific treatment group.
*Eight patients who were randomised to the T&E ranibizumab alone group or the PRN ranibizumab group, supposed to be noted with laser treatment equal to 0, actually received laser treatment in the study eye. These patients were assigned to T&E ranibizumab+laser group in the safety analysis set, although laser was not considered as the study treatment because of the initial randomisation, and as such, these patients were not considered in the analysis of the number of study laser treatments. Because the laser treatment of these eight patients was not the randomised study medication, these cases were recorded in the concomitant medication dataset.
†Treatment visits do not include protocol-mandated intermediary visits.
‡Total number of scheduled treatment visits in this period over all patients in the treatment group.
§Interval after the visit with initial VA stability up to month 24.
¶Percentages are based on n, the number of patients in the safety set and with at least one treatment administered on or after the visit with initial VA stability in the specific treatment group.
BCVA, best-corrected visual acuity; PRN, pro re nata; T&E, treat-and-extend; VA, visual acuity.