with EYLEA) in the VIBRANT study. In the study, patients were randomly assigned in a 1:1 ratio to either 2 mg EYLEA administered every 4 weeks (2Q4) or laser photocoagulation administered at baseline and subsequently as needed (control group). Patient ages ranged from 42 to 94 years with a mean of 65 years.
In the VIBRANT study, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters in BCVA at week 24 compared to baseline. At week 24, the EYLEA 2 mg Q4 group was superior to the control group for the primary endpoint.
Detailed results from the analysis of the VIBRANT study are shown in TABLE 6 and FIGURE 10 below.
Table 6: Efficacy Outcomes at Week 24 (Full Analysis Set with LOCF) in VIBRANT Study
VIBRANT
Control EYLEA
2 mg Q4 weeks
N=90 N=91
* Difference is EYLEA 2 mg Q4 weeks minus Control † Difference and CI are calculated using Mantel-Haenszel weighting scheme adjusted for region (North America vs. Japan) and baseline BCVA category (> 20/200 and ≤ 20/200) ‡ 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 (%) 26.7% 52.7%
Weighted Difference *,† (%)
(95% CI) 26.6%‡
(13.0, 40.1)
Mean change in BCVA as measured by ETDRS letter score from Baseline (SD) 6.9
(12.9) 17.0
(11.9)
Difference in LS mean *,§
(95% CI) 10.5‡
(7.1, 14.0)
Figure 10: Mean Change in BCVA as Measured by ETDRS Letter Score from Baseline to Week 24 in VIBRANT Study
Figure 10
Treatment effects in eva luable subgroups (e.g., age, gender, and baseline retinal perfusion status) in the study were in general consistent with the results in the overall populations.
14.4 Diabetic Macular Edema (DME)
The safety and efficacy of EYLEA were assessed in two randomized, multi-center, double-masked, controlled studies in patients with DME. A total of 862 randomized and treated patients were eva luable for efficacy. Patient ages ranged from 23 to 87 years with a mean of 63 years.
Of those, 576 were randomized to EYLEA groups in the two studies (VIVID and VISTA). In each study, patients were randomly assigned in a 1:1:1 ratio to 1 of 3 dosing regimens: 1) EYLEA administered 2 mg every 8 weeks following 5 initial monthly injections (EYLEA 2Q8); 2) EYLEA administered 2 mg every 4 weeks (EYLEA 2Q4); and 3) macular laser photocoagulation (at baseline and then as needed). Beginning at week 24, patients meeting a pre-specified threshold of vision loss were eligible to receive additional treatment: patients in the EYLEA groups could receive laser and patients in the laser group could receive EYLEA.
In both studies, the primary efficacy endpoint was the mean change from baseline in BCVA at week 52 as measured by ETDRS letter score. Efficacy of both EYLEA 2Q8 and EYLEA 2Q4 groups was statistically superior to the control group. This statistically superior improvement in BCVA was maintained at week 100 in both studies.
Results from the analysis of the VIVID and VISTA studies are shown in TABLE 7 and FIGURE 11 below.
Table 7: Efficacy Outcomes at Weeks 52 and 100 (Full Analysis Set with LOCF) in VIVID and VISTA Studies
VIVID VISTA
EYLEA
2 mg Q8 weeks * EYLEA
2 mg Q4 weeks Control EYLEA
2 mg Q8 weeks * EYLEA
2 mg Q4 weeks Control
Full Analysis Set N=135 N=136 N=132 N=151 N=154&n |
