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Katrin Lorenz, VIVID-DME and VISTA-DME study investigators; Evaluation of Intravitreal Aflibercept for Treatment of Diabetic Macular Edema: Visual Acuity Subgroups in VIVID-DME and VISTA-DME. Invest. Ophthalmol. Vis. Sci. 2014;55(13):5054.
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The Phase 3 trials VIVID-DME and VISTA-DME evaluated the efficacy and safety of 2 mg intravitreal aflibercept injection (IAI or IVT-AFL) for the treatment of diabetic macular edema (DME). Post-hoc subanalyses were conducted using data from patients within these trials who had baseline best-corrected visual acuity (BCVA) of ≥39 to ≤60 or ≥61 to ≤73 letters.
In VIVID-DME (N=406) and VISTA-DME (N=466), patients received laser photocoagulation + sham injection or 5 monthly doses of IAI followed by dosing every 4 weeks + sham laser (2q4) or every 8 weeks + sham laser (2q8). Here we present post-hoc subanalyses of 52-week data from the studies.
Mean baseline demographics and disease characteristics were balanced within studies. The mean increase in BCVA from baseline was significantly greater in the 2q4 and 2q8 arms vs laser in VIVID-DME (10.5, 10.7, and 1.2, respectively, P<0.0001) and in VISTA-DME (12.5, 10.7, and 0.2 letters, respectively, P<0.0001). In patients with a baseline BCVA of ≥39 to ≤60 letters (~37% in both studies), the mean increase in BCVA from baseline was greater in the IAI 2q4 and 2q8 arms vs laser in VIVID-DME (11.9, 11.3, and 2.5 letters, respectively) and VISTA-DME (13.7, 11.4, and 2.6 letters, respectively). In patients with baseline BCVA ≥61 to ≤73 letters (~55% in both trials), the mean increase in BCVA from baseline was greater in the IAI 2q4 and 2q8 arms vs laser in VIVID-DME (9.1, 8.6, and 0.7 letters, respectively) and VISTA-DME (10.5, 9.9, and -0.4 letters, respectively). In the overall population of these studies, the percentage of patients with ≥1 ocular serious adverse events in VIVID-DME was 4.5% in the laser arm and 1.8% in the combined IAI arms and in VISTA-DME was 3.9% in the laser arm and 1.6% in the combined IAI arms.
Subgroup analysis by baseline BCVA in the VIVID-DME and VISTA-DME showed BCVA changes that were consistent with the overall population. Both laser and IAI treatment resulted in slightly better visual outcomes in patients with a baseline BCVA of ≥39 to ≤60 letters in comparison with those with a baseline BCVA of ≥61 to ≤73 letters. These results demonstrate the efficacy of IAI for the treatment of DME and compare favorably with results of similar subgroup analyses in studies of other anti-VEGF compounds.
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