Abstract
Purpose :
To assess the relationship between baseline factors and DME resolution in patients randomized to IAI or laser control in VISTA/VIVID.
Methods :
Of 862 patients in VISTA/VIVID full analysis set, this analysis included 558 patients treated with IAI 2 mg (given either q4 weeks or q8 weeks after 5 monthly doses) and 274 patients treated with laser control; 30 patients with baseline central subfield thickness (CST) <290 µm were excluded. Effect of baseline factors (age, gender, race, ethnicity, diabetes type and duration, HbA1c, hypertension, hyperlipidemia, smoking status, CST, best-corrected visual acuity [BCVA], and DRSS) on time to first DME resolution (CST <290 µm) was assessed in univariate and multivariate models and was further evaluated by Kaplan–Meier method based on tertiles of baseline factors.
Results :
IAI patients had a 2.5-fold higher rate of DME resolution, with median (95% confidence interval [CI]) time of 33.0 (28.1, 40.0) weeks vs not achieved with laser. Based on multivariate analysis of baseline factors, lower DME resolution rate was associated with thicker CST (HR [95% CI] per 100 µm CST increase: 0.79 [0.72, 0.86]) and better BCVA (HR [95% CI] per 5 letters increase: 0.87 [0.83, 0.92]) in the IAI group. Based on Kaplan–Meier analysis, in the IAI group, tertiles of increasing CST (T1: ≤419, T2: 419–541, T3: >541 µm) were associated with significantly longer median time to DME resolution (20.1, 39.1, and 49.1 weeks for T1–T3, respectively; P≤0.0001 for T2 and T3 vs T1) and lower cumulative incidence of the event (HR of 0.6, and 0.6 for T2 and T3 vs T1, respectively, P<0.001 for T2 and T3 vs T1). In the IAI group, tertiles of increasing BCVA (T1: ≤57, T2: 57–66, T3: >66) were also associated with relatively longer median time to DME resolution (28.4, 31.7, and 44.1 weeks for T1–T3, respectively; P<0.05 for T3 vs T1) and lower cumulative incidence of events (HR of 0.9, 0.8 for T2 and T3 vs T1, respectively; P<0.05 for T3 vs T1).
Conclusions :
Thicker CST and better BCVA in the IAI group were baseline factors associated with longer time to and lower rate of DME resolution in VISTA and VIVID. These findings may inform physicians and patients regarding expectations of DME therapy.
This is a 2021 ARVO Annual Meeting abstract.