Session Title: Vascular Diseases and Diabetic Retinopathy I
Session Date/Time: Thursday 11/09/2014 | 08:00-10:00
Paper Time: 08:40
Venue: Boulevard C
First Author: : E.Midena ITALY
Co Author(s): : J-F Korobelnik
To evaluate the impact of baseline visual acuity on best-corrected visual acuity (BCVA) and change in central retinal thickness (CRT) in patients with DME enrolled in 2 similarly-designed studies (VIVID-DME and VISTA-DME).
VIVID-DME and VISTA-DME were similarly-designed, Phase 3 double-masked, randomised, active-controlled clinical trials enrolling patients with DME with central involvement. These studies were conducted to determine the efficacy and safety of IVT-AFL compared with macular laser photocoagulation.
A total of 865 patients (VIVID-DME [n=404]; VISTA-DME [n=461]) were randomised (1:1:1) and received treatment with IVT-AFL 2 mg every 4 weeks (2q4) plus sham laser, IVT-AFL 2 mg every 8 weeks (2q8) (after 5 initial monthly doses) plus sham laser, or laser photocoagulation plus sham IVT treatment. The primary endpoint was the mean change in BCVA at Week 52. Subgroup analyses were performed to evaluate the impact of baseline BCVA on changes in BCVA and CRT at Week 52. Baseline BCVA subgroups (EDTRS letters) for VIVID-DME and VISTA-DME, respectively were <40 (n=30, n=36), ≥40 to <55 (n=69, n=85), ≥55 to <65 (n=125, n=161), and ≥65 (n=179, n=177). Overall, within each study, the subgroup sizes were relatively well balanced among the treatment groups. In VIVID-DME the mean baseline CRT was greater in the laser group compared with the 2q4 and 2q8 groups (540.3 vs 501.9 and 518.4 µm); however, in VISTA-DME, the mean baseline CRT was similar in the 2q4 (485.4 µm), 2q8 (479.0 µm) and laser (483.4 µm) treatment groups.
In VIVID-DME, the mean changes in BCVA from baseline to Week 52 for laser, 2q4, and 2q8, respectively were 2.8, 15.3, and 20.6 (<40); –0.1, 12.0, and 10.2 (≥40-<55); 2.4, 11.6, and 11.5 (≥55-<65) and 0.5, 8.6, and 8.1 (≥65). In VISTA-DME, the mean changes in BCVA from baseline to Week 52 for laser, 2q4, and 2q8, respectively were –4.7, 19.9, and 14.5 (<40); 5.2, 14.1, and 9.4 (≥40-<55); 1.6, 12.8, and 11.7 (≥55-<65); and –1.8, 9.8, and 9.4 (≥65). In VIVID-DME, the mean changes in CRT (µm) from baseline to Week 52 for laser, 2q4, and 2q8, respectively were –29.8, –423.3, and –355.3 (<40); –80.2, –256.2, and –204.9 (≥40-<55); –111.2, –209.1, and – 215.1 (≥55-<65); and –34.7, –135.7, and –132.6 (≥65). In VISTA-DME, the mean changes in CRT (µm) from baseline to Week 52 for laser, 2q4, and 2q8, respectively were –124.9, –358.7, and –401.9 (<40); –145.9, –209.2, and –209.4 (≥40-<55); –72.6, –194.6, and –179.5 (≥55-<65); and –33.7, –131.2, and –128.4 (≥65). Overall, IVT-AFL was generally well tolerated with a similar incidence of adverse events and serious adverse events across the respective IVT-AFL and laser groups, and no significant differences in the incidence of Antiplatelet Trialists’ Collaboration ATE events.
Mean changes in BCVA and CRT based on baseline VA subgroups were consistent with the outcomes seen in the overall study population in that greater improvements were seen in the 2q4 and 2q8 groups compared with the laser treatment group. Furthermore, there was a trend towards greater improvements in visual and anatomical outcomes in patients with worse baseline VA compared with those with better baseline VA.