Primary and secondary outcomes (visual acuity and number of anti-VEGF injections) at month 36
| Baseline to month 36 | Month 24 to month 36 | |||||||||
| EMB+ranibizumab group | Ranibizumab monotherapy group | Difference (95% CI) | EMB+ranibizumab group | Ranibizumab monotherapy group | Difference (95% CI) | |||||
| n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | |||
| Co-primary outcomes | ||||||||||
| BCVA change, ETDRS letters | 238 | −19.7 (18.5) | 119 | −4.8 (12.5) | −14.9 (−18.5 to −11.2) | 238 | −8.9 (12.9) | 119 | −3.4 (8.6) | −5.5 (−8.1 to −2.9) |
| Number of anti-VEGF retreatments* | 244 | 12.1 (8.1) | 119 | 11.4 (6.1) | 0.7 (−0.9 to 2.3) | 200 | 3.6 (3.3) | 102 | 3.9 (2.7) | −0.3 (−1.0 to 0.4) |
| Secondary BCVA outcomes | ||||||||||
| <15 ETDRS letter loss (%) | 244 | 107 (43.9%) | 119 | 95 (79.8%) | 35.9% (25.7 to 44.7) | 244 | 185 (75.8%) | 119 | 111 (93.3%) | 17.5% (10.5 to 24.5) |
| ≥0 ETDRS letter gain (%) | 244 | 35 (14.3%) | 119 | 41 (34.5%) | 20.2% (10.8 to 29.8) | 244 | 54 (22.1%) | 119 | 46 (38.6%) | 16.5% (6.3 to 26.7) |
| ≥15 ETDRS letter gain (%) | 244 | 0 (0.0%) | 119 | 3 (2.5%) | 2.5% (0.2 to 7.2) | 244 | 2 (0.8%) | 119 | 2 (1.7%) | 0.9% (−1.7 to 3.4) |
Results for co-primary outcomes are based on analysis of covariance model of the change in visual acuity, adjusting for baseline visual acuity, baseline lens status and baseline lesion type.
*Ranibizumab was the anti-VEGF agent administered until month 24. After month 24 when the participants returned to standard care, the anti-VEGF drug was either ranibizumab or aflibercept.
BCVA, best-corrected visual acuity; EMB, epimacular brachytherapy; VEGF, vascular endothelial growth factor.