m Baseline 7.9 10.9 8.1 8.9 7.6 9.4
Difference† in LS mean
(95.1% CI) 0.3
(-2.0, 2.5) 3.2
(0.9, 5.4) -0.9
(-3.1, 1.3) -2.0
(-4.1, 0.2)
Number of patients who gained at least 15 letters of vision from Baseline (%) 92
(31%) 114
(38%) 94
(31%) 96
(31%) 91
(29%) 99
(34%)
Difference† (%)
(95.1% CI) -0.4
(-7.7, 7.0) 6.6
(-1.0, 14.1) -2.6
(-10.2, 4.9) -4.6
(-12.1, 2.9)
Figure 8: Mean Change in Visual Acuity from Baseline to Week 52 in VIEW1 and VIEW2 Studies
Figure 8
14.2 Macular Edema Following Central Retinal Vein Occlusion (CRVO)
The safety and efficacy of EYLEA were assessed in two randomized, multi-center, double-masked, sham-controlled studies in patients with macular edema following CRVO. A total of 358 patients were treated and eva luable for efficacy (217 with EYLEA) in the two studies (COPERNICUS and GALILEO). In both studies, patients were randomly assigned in a 3:2 ratio to either 2 mg EYLEA administered every 4 weeks (2Q4), or sham injections (control group) administered every 4 weeks for a total of 6 injections. Patient ages ranged from 22 to 89 years with a mean of 64 years.
In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters in BCVA compared to baseline. At week 24, the EYLEA 2 mg Q4 group was superior to the control group for the primary endpoint.
Results from the analysis of the COPERNICUS and GALILEO studies are shown in TABLE 5 and FIGURE 9 below.
Table 5: Efficacy Outcomes at Week 24 (Full Analysis Set with LOCF) in COPERNICUS and GALILEO Studies
COPERNICUS GALILEO
Control EYLEA
2 mg Q4 weeks Control EYLEA
2 mg Q4 weeks
N=73 N=114 N=68 N=103
* Difference is EYLEA 2 mg Q4 weeks minus Control † Difference and CI are calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for baseline factors; 95.1% confidence intervals were presented to adjust for the multiple assessments conducted during the study. ‡ p<0.01 compared with Control § LS mean and CI based on an ANCOVA model
Efficacy Outcomes
Proportion of patients who gained at least 15 letters in BCVA from Baseline (%) 12% 56% 22% 60%
Weighted Difference *,† (%)
(95.1% CI) 44.8%‡
(32.9, 56.6) 38.3%‡
(24.4, 52.1)
Mean change in BCVA as measured by ETDRS letter score from Baseline (SD) -4.0
(18.0) 17.3
(12.8) 3.3
(14.1) 18.0
(12.2)
Difference in LS mean *,§
(95.1% CI) 21.7‡
(17.3, 26.1) 14.7‡
(10.7, 18.7)
Figure 9: Mean Change in BCVA as Measured by ETDRS Letter Score from Baseline to Week 24 in COPERNICUS and GALILEO Studies
Figure 9
Treatment effects in eva luable subgroups (e.g., age, gender, race, baseline visual acuity, retinal perfusion status, and CRVO duration) in each study and in the combined analysis were in general consistent with the results in the overall populations.
14.3 Macular Edema Following Branch Retinal Vein Occlusion (BRVO)
The safety and efficacy of EYLEA were assessed in a 24-week, randomized, multi-center, double-masked, controlled study in patients with macular edema following BRVO. A total of 181 patients were treated and eva luable for efficacy (91 |
