Table 1

Concentration–time data for free aflibercept (µg/L) in the VIEW 2 and VIVID-DME studies over 52 weeks—all patients (SAF)

VIEW 2 study
TimeAflibercept*
IAI 2 mg every 4 weeksIAI 2 mg every 8 weeks
Number of observations/number of
observations >LLOQ		Mean±SD (range)†Number of observations/number
of observations >LLOQ		Mean±SD (range)†
Week 0, predose169/00‡168/00‡
Week 0, 1–4 hours postdose165/51.95±13.3 (0–148)165/61.91±11.9 (0–124)
Week 1169/394.74±8.96 (0–35.0)166/5210.4±38.9 (0–473)
Week 4, predose170/00‡167/30.65±5.66 (0–67.4)
Week 12, predose164/20.27±2.51 (0–27.8)162/00‡
Week 48, predose151/10.12±1.43 (0–17.6)157/00‡
Week 48, 1–4 hours postdose150/50.81±4.92 (0–48.3)155/40.97±6.93 (0–70)
Week 52, predose150/00‡157/00‡
VIVID-DME study
TimeAflibercept‡
IAI 2 mg every 4 weeksIAI 2 mg every 8 weeks
Number of observations/number of
observations >LLOQ		Mean±SD (range)Number of observations/number
of observations >LLOQ		Mean±SD (range)
Baseline, predose129/10.20±2.29 (0–26.0)128/00‡
Week 0, 1–4 hours postdose127/31.30±11.8 (0–131)128/32.21±17.1 (0–171)
Week 0, 2–4 days postdose§125/6215.8±20.0 (0–103)125/7321.1±24.9 (0–129)
Week 24, predose125/00‡130/00‡
Week 52, predose121/10.17±1.92 (0–21.1)119/00‡

  • *For the 0.5 every 4 weeks dose group only two individual plasma samples had free aflibercept concentrations >LLOQ, and are thus not presented here.

  • †Maximum mean concentration:arithmetic mean.

  • ‡All values <LLOQ.

  • §Samples were taken at visit 2 only.

  • IAI, intravitreal aflibercept injection; LLOQ, lower limit of quantification; SAF, safety analysis set.