bsp;N=154
* After treatment initiation with 5 monthly injections † LS mean and CI based on an ANCOVA model with baseline BCVA measurement as a covariate and a factor for treatment group. Additionally, protocol specified stratification factors were included in the model. ‡ Difference is EYLEA group minus Control group § p<0.01 compared with Control ¶ Difference with confidence interval (CI) and statistical test is calculated using Mantel-Haenszel weighting scheme adjusted by protocol specified stratification factors.
Efficacy Outcomes at Week 52
Mean change in BCVA as measured by ETDRS letter score from Baseline (SD) 10.7
(9.3) 10.5
(9.6) 1.2
(10.6) 10.7
(8.2) 12.5
(9.5) 0.2
(12.5)
Difference†, ‡ in LS mean
(97.5% CI) 9.1§
(6.3, 11.8) 9.3§
(6.5, 12.0) 10.5§
(7.7, 13.2) 12.2§
(9.4, 15.0)
Proportion of patients who gained at least 15 letters in BCVA from Baseline (%) 33.3% 32.4% 9.1% 31.1% 41.6% 7.8%
Adjusted Difference‡, ¶ (%)
(97.5% CI) 24.2%§
(13.5, 34.9) 23.3%§
(12.6, 33.9) 23.3%§
(13.5, 33.1) 34.2%§
(24.1, 44.4)
Efficacy Outcomes at Week 100
Mean change in BCVA as measured by ETDRS letter score from Baseline (SD) 9.4
(10.5) 11.4
(11.2) 0.7
(11.8) 11.1
(10.7) 11.5
(13.8) 0.9
(13.9)
Difference†, ‡ in LS mean
(97.5% CI) 8.2§
(5.2, 11.3) 10.7§
(7.6, 13.8) 10.1§
(7.0, 13.3) 10.6§
(7.1, 14.2)
Proportion of patients who gained at least 15 letters in BCVA from Baseline (%) 31.1% 38.2% 12.1% 33.1% 38.3% 13.0%
Adjusted Difference‡, ¶ (%)
(97.5% CI) 19.0%§
(8.0, 29.9) 26.1%§
(14.8, 37.5) 20.1%§
(9.6, 30.6) 25.8%§
(15.1, 36.6)
Figure 11: Mean Change in BCVA as Measured by ETDRS Letter Score from Baseline to Week 100 in VIVID and VISTA Studies
Figure 11
Treatment effects in the subgroup of patients who had previously been treated with a VEGF inhibitor prior to study participation were similar to those seen in patients who were VEGF inhibitor naïve prior to study participation.
Treatment effects in eva luable subgroups (e.g., age, gender, race, baseline HbA1c, baseline visual acuity, prior anti-VEGF therapy) in each study were in general consistent with the results in the overall populations.
14.5 Diabetic Retinopathy (DR) in Patients with DME
In the VIVID and VISTA studies, an efficacy outcome was the change in the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (ETDRS-DRSS). The ETDRS-DRSS score was assessed at baseline and approximately every 6 months thereafter for the duration of the studies [see CLINICAL STUDIES (14.4)].
All enrolled patients had DR and DME at baseline. The majority of patients enrolled in these studies (77%) had moderate-to-severe nonproliferative diabetic retinopathy (NPDR) based on the ETDRS-DRSS. At week 100, the proportion of patients improving by at least 2 steps on the ETDRS-DRSS was significantly greater in both EYLEA treatment groups (2Q4 and 2Q8) when compared to the control group.
Results from t |
