erence was maintained through week 52.
Detailed results from the analysis of both studies are shown in the Table and Figure below.
Table 4: Efficacy outcomes at week 24, week 52 and week 76/100 (Full Analysis Set with LOCFC)) in COPERNICUS and GALILEO studies
Efficacy Outcomes
COPERNICUS
GALILEO
24 Weeks
52 Weeks
100 Weeks
24 Weeks
52 Weeks
76 Weeks
Control
Eylea
2 mg Q4
ControlE)
Eylea
2 mg
Control E,F)
Eylea F)
2 mg
Control
Eylea
2 mg Q4
Control
Eylea
2 mg
Control G)
Eylea G)
2 mg
(n = 73)
(n = 114)
(n = 73)
(n = 73)
(n = 114)
(n = 114)
(n = 68)
(n = 103)
(n = 68)
(n = 103)
(n = 68)
(n = 103)
Proportion of patients who gained at least 15 letters in BCVAC) from baseline
12%
56%
30%
55%
23.3%
49.1%
22%
60%
32%
60%
29.4%
57.3%
Weighted differenceA,B,E)
(95% CI)
44.8%
(33.0, 56.6)
25.9%
(11.8, 40.1)
26.7%
(13.1, 40.3)
38.3%
(24.4, 52.1)
27.9%
(13.0, 42.7)
28.0%
(13.3, 42.6)
p-value
p < 0.0001
p = 0.0006
p=0.0003
p < 0.0001
p = 0.0004
p=0.0004
Mean change in BCVA as measured by ETDRSC) letter score from baseline (SD)
-4.0
(18.0)
17.3
(12.8)
3.8
(17.1)
16.2
(17.4)
1.5
(17.7)
13.0
(17.7)
3.3
(14.1)
18.0
(12.2)
3.8
(18.1)
16.9
(14.8)
6.2
(17.7)
13.7
(17.8)
Difference in LS meanA,C,D,E)
(95% CI)
21.7
(17.4, 26.0)
12.7
(7.7, 17.7)
11.8
( 6.7, 17.0)
14.7
(10.8, 18.7)
13.2
(8.2, 18.2)
7.6
(2.1, 13.1)
p-value
p < 0.0001
p < 0.0001
p < 0.0001
p < 0.0001
p < 0.0001
p=0.0070
A) Difference is Eylea 2 mg Q4 weeks minus control
B) Difference and confidence interval (CI) are calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for region (America vs. rest of the world for COPERNICUS and Europe vs. Asia/Pacific for GALILEO) and baseline BCVA category (> 20/200 and ≤ 20/200)
C) BCVA: Best Corrected Visual Acuity
ETDRS: Early Treatment Diabetic Retinopathy Study
LOCF: Last Observation Carried Forward
SD: Standard deviation
LS: Least square means derived from ANCOVA
D) LS mean difference and confidence interval based on an ANCOVA model with factors treatment group, region (America vs. rest of the world for COPERNICUS and Europe vs. Asia/Pacific for GALILEO) and baseline BCVA category (> 20/200 and ≤ 20/200)
E) In COPERNICUS study, control group patients could receive Eylea on an as-needed basis as frequently as every 4 weeks during week 24 to week 52
F) In COPERNICUS study, both control group and Eylea 2mg patients received Eylea 2 mg on an as-needed basis as frequent |
