Correlation of Change in Macular Thickness With Change in Visual Acuity in Diabetic Macular Edema: Post Hoc Analysis of VISTA and VIVID Trials

Abstract

Purpose: To assess the correlation between the change in central subfield thickness (CST) and change in best-corrected visual acuity (BCVA) in eyes with diabetic macular edema (DME) treated with fixed-dosing intravitreal aflibercept injection (IAI). Methods: This post hoc analysis of the VISTA and VIVID randomized controlled clinical trials, in which 862 eyes with central-involved DME were randomly assigned to IAI 2 mg every 4 weeks (2q4; 290 eyes), IAI 2 mg every 8 weeks after 5 initial monthly doses (2q8; 286 eyes), or macular laser (286 eyes) and followed through 100 weeks. Correlations between the change in CST and change in BCVA from baseline to weeks 12, 52, and 100 were assessed using the Pearson correlation. Results: The respective correlations (r [95% CI]) at weeks 12, 52, and 100 were -0.39 (-0.49 to -0.29), -0.27 (-0.38 to -0.15), and -0.30 (-0.41 to -0.17) in the 2q4 arm and -0.28 (-0.39 to -0.17), -0.29 (-0.41 to -0.17), and -0.33 (-0.44 to -0.20) in the 2q8 arm. Linear regression analysis of the correlation at week 100, adjusted for relevant baseline factors, showed CST changes accounted for 17% of the variance in BCVA changes; every 100-µm decrease in CST was associated with a 1.2-letter increase in BCVA (P = .001). Conclusions: Correlations between the change in CST and change in BCVA after 2q4 or 2q8 fixed-dosing IAI for DME were modest. Although a change in CST might be important in determining the need for antivascular endothelial growth factor for DME at follow-up, it was not a good surrogate for VA outcomes.

Keywords: aflibercept; anti-VEGF; central subfield thickness; correlation; diabetic macular edema; visual acuity.

Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Drs Nanegrungsunk and Gu declare no conflict of interest. Dr S. Bressler has received grants to Johns Hopkins University School of Medicine from Bayer, Biocon, Biogen, Boehringer-Ingleheim Pharma GmbH & Co, EyePoint, Genentech (Roche), Mylan Inc, Notal Vision, Novartis, and Regeneron Pharmaceuticals Inc, and has a contract with Amgen as chair of the Data and Safety Monitoring Committee; Drs Du, Amer, and Moini are salaried employees with and have stock ownership in Regeneron Pharmaceuticals, Inc. Dr N. Bressler has received grants to Johns Hopkins University from Bayer, Biogen, Genentech (Roche), Novartis, Regeneron Pharmaceuticals, Inc, and Samsung Bioepis, and has contract with the American Medical Association as editor-in-chief of JAMA Ophthalmology.

© The Author(s) 2022.

Figures

Figure 1.

Correlations between changes in BCVA and changes in CST from baseline in patients treated with IAI 2q4 at (A) week 12, (B) week 52, and (C) week 100. Solid lines indicate the correlation line, and dashed lines indicate the 95% CI. Abbreviations: 2q4, 2 mg every 4 weeks; BCVA, best-corrected visual acuity; CST, central subfield thickness; IAI, intravitreal aflibercept injection; r, correlation;R2, coefficient of determination.

Figure 2.

Correlations between changes in BCVA and changes in CST from baseline in patients treated with IAI 2q8 at (A) week 12, (B) week 52, and (C) week 100. Solid lines indicate the correlation line, and dashed lines indicate the 95% CI. Abbreviations: 2q8, 2 mg every 8 weeks after 5 initial monthly doses; BCVA, best-corrected visual acuity; CST, central subfield thickness; IAI, intravitreal aflibercept injection;r, correlation; R2, coefficient of determination.