Table 1.
Comparison of baseline characteristics for those evaluated at 5 years in the RAINBOW extension study and the core study population from RAINBOW.
| Entered into extension study | Ranibizumab 0.2 mg |
Ranibizumab 0.1 mg |
Laser |
Core study population |
|---|---|---|---|---|
| 61 | 65 | 54 | n = 225 | |
| Gestational age at birth | ||||
| Median [range] | 25.0 [23–32] weeks | 26.0 [23–32] weeks | 26.0 [23–32] weeks | 26 [23–32] weeks |
| No. ≤ 24 weeks | 25 (41%) | 21 (32%) | 19 (35%) | 37% |
| >24–<27 weeks | 16 (26%) | 19 (29%) | 11 (20%) | 25% |
| ≥27 weeks | 20 (33%) | 25 (38%) | 24 (44%) | 38% |
| Male Sex | 29 (48%) | 30 (46%) | 27 (50%) | 107 (48%) |
| Multiple birth | 16/58 (28%) | 16/63 (25%) | 16/49 (33%) | 54/207 (26%) |
| Geographical region | ||||
| Region 1 (NNMa ≤5 × 103) | 38 (62%) | 41 (63%) | 33 (61%) | 134 (60%) |
| Region 2 (NNMa >5 × 103) | 23 (38%) | 24 (37%) | 21 (39%) | 91 (40%) |
| Ethnic group | ||||
| White | 38 (62%) | 40 (62%) | 32 (59%) | 110 (61%) |
| Black | 0 | 4 (6%) | 2 (4%) | 6 (3%) |
| Asian | 22 (36%) | 18 (28%) | 18 (33%) | 58 (32%) |
| Other | 1 (2%) | 3 (5%) | 2 (4%) | 6 (3%) |
| Postmenstrual age core study entry (median [range]) | 37.0 [30.3–51.9] weeks | 36.9 [31.9–44.6] weeks | 36.3 [31–47.6] weeks | |
| Postmenstrual age at extension study entry (w) | 63.1 [56.7–95.1] weeks | 64.0 [56.6–106.1] weeks | 61.7 [55–99.6] weeks | |
| Site of ROP at core study enrolmentb | ||||
| Zone I | 23 (38%) | 25 (38%) | 21 (39%) | 86 (38%) |
| Zone II | 38 (62%) | 40 (62%) | 33 (61%) | 138 (62%)b |
| Aggressive posterior-ROP at core study enrolment | 7 (11%) | 8 (12%) | 8 (15%) | 30 (13%) |
| Worst grade of ROP/subject at core study enrolment | ||||
| Zone I AP ROP | 7 | 8 | 7 | 29 |
| Zone II AP ROP | – | – | 1 | 1 |
| Zone I stage 3+ | 10 | 11 | 8 | 37 |
| Zone I stage 3 | 3 | 4 | 1 | 8 |
| Zone I stage 2+ | 3 | 1 | 4 | 9 |
| Zone I stage 1+ | – | 1 | 1 | 3 |
| Zone II stage 3+ | 38 | 39 | 32 | 135 |
| Zone II stage 3 | – | 1 | – | 1 |
| Zone II stage 2+ | 1 | |||
| Completed 5 year study | 54 (89%) | 55 (85%) | 47 (87%) |
a
NNM, neonatal mortality in respective countries at time of core study.
b
1 patient (who received ranibizumab 0.1 mg) had no Zone specified.