Abstract

Determine correlation between change in central subfield thickness (CST) and change in best-corrected visual acuity (BCVA) in neovascular age-related macular degeneration receiving anti-vascular endothelial growth factor agents. A post hoc analysis of VIEW 1 and 2 randomized clinical trials. This analysis included participants randomized to ranibizumab 0.5 mg every 4 weeks (Rq4), intravitreal aflibercept injection 2 mg every 4 weeks (2q4), and intravitreal aflibercept injection 2 mg every 8 weeks after 3 monthly doses (2q8) to week 52, followed by capped as-needed (at least every 12 weeks) dosing to week 96. Relationship between changes in CST and BCVA was determined using Pearson correlation coefficient. Of 1815 eyes, 595 were assigned to the Rq4, 613 to 2q4, and 607 to 2q8 arms. Correlations (95% confidence intervals [CI]) at weeks 12, 52, and 96 were -0.08 (95% CI, -0.17 to 0.00), -0.05 (95% CI, -0.14 to 0.04), and -0.15 (95% CI, -0.24 to -0.06) for Rq4; -0.13 (95% CI, -0.21 to -0.04), -0.06 (95% CI, -0.14 to 0.03) and -0.04 (95% CI, -0.13 to 0.05) for 2q4, and -0.04 (95% CI, -0.12 to 0.05), -0.01 (95% CI, -0.09 to 0.08), and -0.01 (95% CI, -0.10 to 0.09) for 2q8. Linear regression analysis adjusted for relevant baseline factors showed CST changes accounted for 11% of BCVA changes. Every 100 μm decrease in CST was associated with a 0.3 letter decrease (P = .25) at week 52 and a 0.14 letter decrease (P = .69) at week 96. Weak or no correlation was found between changes in CST and BCVA with either agent or regimen, suggesting changes in CST should not be used as a surrogate for visual acuity outcomes in neovascular age-related macular degeneration.

Highlights

  • Several studies have explored biomarkers that may predict visual acuity outcomes in eyes with neovascular age-related macular degeneration or response after treatment with intravitreal anti-vascular endothelial growth factor injections

  • Weak or no correlation was found between changes in central subfield thickness (CST) and best-corrected visual acuity (BCVA) with either agent or regimen, suggesting changes in CST should not be used as a surrogate for visual acuity outcomes in neovascular age-related macular degeneration (nAMD)

  • An analysis from the Comparison of Age-related Macular Degeneration Treatments Trials (CATT) suggested that new foveal scarring, active choroidal neovascularization (CNV), intraretinal fluid (IRF), subretinal hyper-reflective material (SHRM), retinal thinning, progression of geographic atrophy, or increased lesion size at follow-up may be associated with visual acuity outcomes when managing eyes with intravitreal bevacizumab or ranibizumab.[1]

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Summary

Introduction

Several studies have explored biomarkers that may predict visual acuity outcomes in eyes with neovascular age-related macular degeneration (nAMD) or response after treatment with intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections. If 1 eye has a greater reduction in central subfield thickness (CST) than another eye following treatment, these outcomes do not necessarily mean that the eye with greater reduction in CST will have better visual acuity than the eye that did not have as great a reduction in CST When looking at this relationship in other conditions receiving anti-VEGF therapy, in eyes with centerinvolved diabetic macular edema (DME) and vision impairment, a weak correlation was found between change in CST and change in best-corrected visual acuity (BCVA) following a pro re nata (PRN) treatment regimen with either aflibercept, bevacizumab, or ranibizumab.[4] This relationship has been investigated in eyes with nAMD treated with fixed, PRN, or treat-and-extend regimens using ranibizumab; no strong correlation with visual acuity at follow-up with these parameters was found.[5] To date, to our knowledge, studies have not explored this relationship in eyes with nAMD managed with intravitreal aflibercept injection (IAI)

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