ndomised but on a modified dosing schedule guided by assessment of visual and anatomic outcomes with a protocol-defined maximum dosing interval of 12 weeks.
In both studies, the primary efficacy endpoint was the proportion of patients in the Per Protocol Set who maintained vision, defined as losing fewer than 15 letters of visual acuity at week 52 compared to baseline.
In the VIEW1 study, at week 52, 95.1% of patients in the Eylea 2Q8 treatment group maintained vision compared to 94.4% patients in the ranibizumab 0.5Q4 group. Eylea treatment was shown to be non-inferior and clinically equivalent to the ranibizumab 0.5Q4 group.
In the VIEW2 study, at week 52, 95.6% of patients in the Eylea 2Q8 treatment group maintained vision compared to 94.4% patients in the ranibizumab 0.5Q4 group. Eylea treatment was shown to be non-inferior and clinically equivalent to the ranibizumab 0.5Q4 group.
Detailed results from the combined analysis of both studies are shown in the Table and Figure below.
Table 3: Efficacy outcomes at week 52 (primary analysis) and week 96; combined data from the VIEW1 and VIEW2 studiesB)
Efficacy Outcome
Eylea 2Q8 E)
(Eylea 2 mg every 8 weeks following 3 initial monthly doses)
Ranibizumab 0.5Q4
(ranibizumab 0.5 mg every 4 weeks)
(n = 607)
(n = 595)
Week 52
Week 96 G)
Week 52
Week 96 G)
Mean number of injections from baseline
7.6
11.2
12.3
16.5
Mean number of injections during second year (Week 52 to 96)
4.2
4.7
Proportion of patients with maintained visual acuity
(< 15 letters of BCVAA) loss) (Per Protocol Set)
95.33%B)
92.42%
94.42% B)
91.60%
DifferenceC)
(95% CI)D)
0.9%
(-1.7, 3.5)F)
0.8%
(-2.3, 3.8)F)
Mean change in BCVA as measured by ETDRSA) letter score from baseline
8.40
7.62
8.74
7.89
Difference in LS A) mean change (ETDRS letters)C)
(95% CI)D)
-0.32
(-1.87, 1.23)
-0.25
(-1.98, 1.49)
Proportion of patients who gained at least 15 letters of vision from baseline
30.97%
33.44%
32.44%
31.60%
DifferenceC)
(95% CI)D)
-1.5%
(-6.8, 3.8)
1.8%
(-3.5, 7.1)
A) BCVA: Best Corrected Visual Acuity
ETDRS: Early Treatment Diabetic Retinopathy Study
LS: Least square means derived from ANCOVA
B) Full Analysis Set (FAS), Last Observation Carried Forward (LOCF) for all analyses except proportion of patients with maintained visual acuity at week 52 which is Per Protocol Set (PPS)
C) The difference is the value of the Eylea group minus the value of the ranibizumab group. A positive value favours Eylea.
D) Confidence interval (CI) calculated by normal approximation
E) After treatment initiation with three monthly doses
F) A confidence interval lying entirely above -10% indicates a non-inferiority of Eylea to ranibizumab
G) Beginning at week 52, all groups were treated using a modified quarterly treatment paradigm where patients could be dosed as frequently as every 4 weeks but not less frequently than every 12 weeks based upon pre-specified retreatment criteria
Figure 1. Mean Change in Visual Acuity from Baseline to Week 96 for the Combined Data from the View1 and View2 Studies
*) From Baseline to Week 52, Eylea was dosed every 8 weeks following 3 initial month |
