Time to Resolution of Diabetic Macular Edema after Treatment with Intravitreal Aflibercept Injection or Laser in VISTA and VIVID.

ABSTRACT

OBJECTIVE: To assess the relationship between baseline factors and time to diabetic macular edema (DME) resolution. DESIGN: Post hoc analysis of VISTA and VIVID. PARTICIPANTS: Eyes with baseline central subfield thickness (CST) of ≥ 290 µm. INTERVENTION Eyes were treated with intravitreal aflibercept injection (IAI) 2 mg (n = 558; every 4 weeks or every 8 weeks after 5 monthly doses) or laser control (n = 274). The effect of baseline factors on the time to DME resolution (CST < 290 µm) was assessed in univariable and multivariable models and further evaluated by the Kaplan-Meier method. MAIN OUTCOME MEASURES: Time to and cumulative incidence of DME resolution. RESULTS: Eyes treated with IAI had a 2.5-fold higher DME resolution rate, with median time of 33.0 weeks (95% confidence interval [CI], 28.1-40.0), compared with DME resolution not being achieved in 50% of eyes treated with laser control. Multivariable analysis demonstrated that a lower DME resolution rate was associated with a thicker baseline CST (hazard ratio [HR] [95% CI] per 100-µm CST increase, 0.79 [0.72-0.86]) and better baseline best-corrected visual acuity (BCVA) (HR [95% CI] per 5-letter increase, 0.87 [0.83-0.92]) with IAI. Tertiles of increasing CST (T1CST ≤ 419 µm; T2CST > 419 to ≤ 541; T3CST > 541) were associated with longer median times to DME resolution (20.1, 39.1, and 49.1 weeks, respectively; P < 0.001 for T2CST and T3CST versus T1CST) and lower cumulative incidence of events (HR, 1.0, 0.6, and 0.6, respectively; P < 0.001 for T2CST and T3CST versus T1CST) with IAI. Tertiles of increasing BCVA (T1BCVA ≤ 57 letters; T2BCVA > 57 to ≤ 66; T3BCVA >66) were associated with longer median times to DME resolution (28.4, 31.7, and 44.1 weeks, respectively; P < 0.05 for T3BCVA versus T1BCVA) and lower cumulative incidence of events (HR, 1.0, 0.9, and 0.8, respectively; P < 0.05 for T3BCVA versus T1BCVA) with IAI. No other baseline factor was associated with the time to DME resolution. CONCLUSIONS: The median time to DME resolution was 33 weeks among IAI-treated eyes. A thicker baseline CST and better baseline BCVA in the IAI group were associated with a longer time to and a lower rate of DME resolution.