Table 2. Primary and Secondary Outcomes at Month 24.
| Variable | EMB + ranibizumab group | Ranibizumab monotherapy group | Difference (95% CI) | ||
|---|---|---|---|---|---|
| No. | Mean (SD) | No. | Mean (SD) | ||
| Coprimary outcomes | |||||
| BCVA change from baseline, ETDRS lettersa | 243 | –11.2 (15.7) | 119 | –1.4 (10.9) | –9.8 (–6.7 to –12.9) |
| Number of ranibizumab retreatments | 244 | 9.3 (6.7) | 119 | 8.3 (4.5) | 1.0 (–0.3 to 2.3) |
| Secondary outcomes: BCVA | |||||
| <15 ETDRS letter loss from baseline, No. (%) | 244 | 160 (65.6) | 119 | 103 (86.6) | 21 (12.4 to 29.5) |
| ≥0 ETDRS letter gain from baseline, No. (%) | 244 | 69 (28.3) | 119 | 61 (51.3) | 23 (12.4 to 33.6) |
| ≥15 ETDRS letter gain from baseline, No. (%) | 244 | 2 (0.8) | 119 | 4 (3.4) | 2.6 (–0.9 to 6.0) |
| Secondary outcomes: FFA and OCT | |||||
| Change in total lesion size, mm2 | 196 | 4.1 (8.7) | 96 | 2.1 (5.8) | 2.0 (0.04 to 3.9) |
| Change in total CNV size, mm2 | 196 | 2.6 (10.0) | 96 | 0.04 (6.3) | 2.6 (0.3 to 4.7) |
| Change in foveal thickness, μm | 213 | 7.0 (193) | 100 | –20.0 (130) | 27 (–14.8 to 68.8) |
Abbreviations: BCVA, best-corrected visual acuity; CNV, choroidal neovascularization; EMB, epimacular brachytherapy; ETDRS, Early Treatment Diabetic Retinopathy Study; FFA, fundus fluorescein angiography; OCT, optical coherence tomography.
a
Results 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.