Impact of Baseline (BL) Visual Acuity (VA) in the VIVID‐DME and VISTA‐DME trials

Abstract

AbstractPurpose To evaluate the impact of BL VA on changes in best‐corrected VA (BCVA) and central retinal thickness (CRT) in patients (pts) with diabetic macular edema (DME) in the VIVID‐DME and VISTA‐DME trials.Methods Pts received intravitreal aflibercept (IVT‐AFL) 2 mg plus sham laser every 4 wks (2q4) or every 8 wks (2q8) (after 5 monthly doses), or laser photocoagulation plus sham IVT treatment. Subgroup analyses assessed the impact of BL BCVA on changes in BCVA and CRT at Week 52 (W52). BL BCVA subgroups were <40, ≥40‐<55, ≥55‐<65, and ≥65 ETDRS letters.Results VIVID‐DME: Mean BCVA changes from BL to W52 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). Mean CRT changes (µm) for laser, 2q4, and 2q8 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). VISTA‐DME: Mean BCVA changes from BL to W52 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). Mean CRT changes (µm) for laser, 2q4, and 2q8 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). IVT‐AFL was generally well tolerated. Incidence of AEs and serious AEs was similar across all groups, with no significant differences in the incidence of APTC events.Conclusion Outcomes based on BL VA were consistent with those in the overall study population, with greater improvements seen in the IVT‐AFL groups vs laser. There was a trend towards greater improvements in pts with worse vs better BL VA. Commercial interest