Impact of Baseline Central Retinal Thickness on Outcomes in the VIVID-DME and VISTA-DME Studies

Edoardo Midena, Mark Gillies, Todd A Katz, Carola Metzig, Chengxing Lu, Yuichiro Ogura, Edoardo Midena, Mark Gillies, Todd A Katz, Carola Metzig, Chengxing Lu, Yuichiro Ogura

Abstract

Purpose: To report the impact of baseline central retinal thickness (CRT) on outcomes in patients with diabetic macular edema (DME) in VIVID-DME and VISTA-DME.

Methods: Post hoc analyses of two randomized controlled trials in which 862 DME patients were randomized 1 : 1 : 1 to treatment with intravitreal aflibercept 2.0 mg every 4 weeks (2q4), intravitreal aflibercept 2.0 mg every 8 weeks after five initial monthly doses (2q8), or macular laser photocoagulation at baseline and as needed. We compared visual and anatomical outcomes in subgroups of patients with baseline CRT < 400 μm and ≥400 μm.

Results: At weeks 52 and 100, outcomes with intravitreal aflibercept 2q4 and 2q8 were superior to those in laser control-treated patients regardless of baseline CRT. When looked at in a binary fashion, the treatment effect of intravitreal aflibercept versus laser was not significantly better in the ≥400 μm than the <400 μm group; when looked at as a continuous variable, baseline CRT seemed to have an impact on the treatment effect of intravitreal aflibercept versus laser.

Conclusions: Post hoc analyses of VIVID-DME and VISTA-DME demonstrated the benefits of intravitreal aflibercept treatment in DME patients with baseline CRT < 400 μm and ≥400 μm. This trial is registered with NCT01331681 and NCT01363440.

Figures

Figure 1
Figure 1
Least squares mean change in best-corrected visual acuity by a visit from baseline to week 100 for patients with (a) baseline central retinal thickness μm and (b) baseline central retinal thickness ≥ 400 μm (full analysis set, last observation carried forward, adjusted for baseline visual acuity). ETDRS: Early Treatment Diabetic Retinopathy Study.
Figure 2
Figure 2
Least squares mean change in BCVA by baseline central retinal thickness and BCVA subgroups, adjusted for baseline BCVA at (a) week 52 and (b) week 100. BCVA: best-corrected visual acuity; ETDRS: Early Treatment Diabetic Retinopathy Study.

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Source: PubMed

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